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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1193938810 | 11939388 | 10 | F | 20151207 | 20160629 | 20160122 | 20160704 | EXP | CO-ABBVIE-16K-036-1541872-00 | ABBVIE | 76.60 | YR | F | Y | 55.00000 | KG | 20160704 | CN | COUNTRY NOT SPECIFIED | CO |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1193938810 | 11939388 | 1 | PS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | 53087XH06 | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | QOW | ||||||
| 1193938810 | 11939388 | 2 | SS | NITROFURANTOIN. | NITROFURANTOIN | 1 | Unknown | N | UNKNOWN | 0 | TABLET | Q12H | |||||||
| 1193938810 | 11939388 | 3 | C | FOLIC ACID. | FOLIC ACID | 1 | 0 | TABLET | QD | ||||||||||
| 1193938810 | 11939388 | 4 | C | WINADEINE | 2 | BY PAIN | 0 | TABLET | Q8H | ||||||||||
| 1193938810 | 11939388 | 5 | C | MESALAZINE | MESALAMINE | 1 | 0 | TABLET | |||||||||||
| 1193938810 | 11939388 | 6 | C | AZATHIOPRINE. | AZATHIOPRINE | 1 | 0 | TABLET | Q12H |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 1193938810 | 11939388 | 1 | Colitis ulcerative |
| 1193938810 | 11939388 | 2 | Product used for unknown indication |
| 1193938810 | 11939388 | 3 | Product used for unknown indication |
| 1193938810 | 11939388 | 4 | Pain |
| 1193938810 | 11939388 | 5 | Product used for unknown indication |
| 1193938810 | 11939388 | 6 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 1193938810 | 11939388 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 1193938810 | 11939388 | Anal fistula | |
| 1193938810 | 11939388 | Anovulvar fistula | |
| 1193938810 | 11939388 | Bacterial test positive | |
| 1193938810 | 11939388 | Bladder hyperaemia | |
| 1193938810 | 11939388 | Bladder injury | |
| 1193938810 | 11939388 | Brenner tumour | |
| 1193938810 | 11939388 | Circulatory collapse | |
| 1193938810 | 11939388 | Cystitis | |
| 1193938810 | 11939388 | Diarrhoea | |
| 1193938810 | 11939388 | Drug ineffective | |
| 1193938810 | 11939388 | Enterovesical fistula | |
| 1193938810 | 11939388 | Gastrointestinal wall thickening | |
| 1193938810 | 11939388 | Haemorrhoids | |
| 1193938810 | 11939388 | Hypertonic bladder | |
| 1193938810 | 11939388 | Intestinal stenosis | |
| 1193938810 | 11939388 | Large intestinal stenosis | |
| 1193938810 | 11939388 | Large intestinal ulcer | |
| 1193938810 | 11939388 | Large intestine polyp | |
| 1193938810 | 11939388 | Lymphoid tissue hyperplasia | |
| 1193938810 | 11939388 | Peritonitis | |
| 1193938810 | 11939388 | Pseudopolyposis | |
| 1193938810 | 11939388 | Reduced bladder capacity | |
| 1193938810 | 11939388 | Urinary bladder polyp | |
| 1193938810 | 11939388 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 1193938810 | 11939388 | 1 | 20150429 | 20160315 | 0 |