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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121062373 | 12106237 | 3 | F | 20130813 | 20160729 | 20160223 | 20160803 | EXP | JP-ABBVIE-14P-087-1299474-00 | ABBVIE | 27.00 | YR | F | Y | 59.00000 | KG | 20160803 | MD | COUNTRY NOT SPECIFIED | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121062373 | 12106237 | 1 | PS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | Y | UNKNOWN | 125057 | 160 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | ||||||
| 121062373 | 12106237 | 2 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | Y | UNKNOWN | 125057 | 80 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | ||||||
| 121062373 | 12106237 | 3 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | Y | UNKNOWN | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | QOW | |||||
| 121062373 | 12106237 | 4 | C | MESALAZINE | MESALAMINE | 1 | Oral | 0 | TABLET | ||||||||||
| 121062373 | 12106237 | 5 | C | MESALAZINE | MESALAMINE | 1 | 0 | ||||||||||||
| 121062373 | 12106237 | 6 | C | TACROLIMUS. | TACROLIMUS | 1 | Oral | 0 | CAPSULE | ||||||||||
| 121062373 | 12106237 | 7 | C | AZATHIOPRINE. | AZATHIOPRINE | 1 | Oral | 0 | |||||||||||
| 121062373 | 12106237 | 8 | C | PARENTERAL | 2 | Oral | 0 | ||||||||||||
| 121062373 | 12106237 | 9 | C | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 0 | 20 | MG | |||||||||
| 121062373 | 12106237 | 10 | C | PREDNISOLONE. | PREDNISOLONE | 1 | 0 | 15 | MG | ||||||||||
| 121062373 | 12106237 | 11 | C | PREDNISOLONE. | PREDNISOLONE | 1 | 0 | 12.5 | MG | ||||||||||
| 121062373 | 12106237 | 12 | C | PREDNISOLONE. | PREDNISOLONE | 1 | 0 | 15 | MG | ||||||||||
| 121062373 | 12106237 | 13 | C | PREDNISOLONE. | PREDNISOLONE | 1 | 0 | 12.5 | MG | ||||||||||
| 121062373 | 12106237 | 14 | C | PREDNISOLONE. | PREDNISOLONE | 1 | 0 | 15 | MG | ||||||||||
| 121062373 | 12106237 | 15 | C | PREDNISOLONE. | PREDNISOLONE | 1 | 0 | ||||||||||||
| 121062373 | 12106237 | 16 | C | PREDNISOLONE. | PREDNISOLONE | 1 | 0 | 15 | MG | ||||||||||
| 121062373 | 12106237 | 17 | C | PREDNISOLONE. | PREDNISOLONE | 1 | 0 | ||||||||||||
| 121062373 | 12106237 | 18 | C | ALFACALCIDOL | ALFACALCIDOL | 1 | Oral | 0 | .5 | UG | |||||||||
| 121062373 | 12106237 | 19 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Oral | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121062373 | 12106237 | 1 | Behcet's syndrome |
| 121062373 | 12106237 | 4 | Behcet's syndrome |
| 121062373 | 12106237 | 6 | Behcet's syndrome |
| 121062373 | 12106237 | 7 | Behcet's syndrome |
| 121062373 | 12106237 | 8 | Behcet's syndrome |
| 121062373 | 12106237 | 9 | Behcet's syndrome |
| 121062373 | 12106237 | 18 | Prophylaxis |
| 121062373 | 12106237 | 19 | Prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 121062373 | 12106237 | LT |
| 121062373 | 12106237 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121062373 | 12106237 | Abdominal pain | |
| 121062373 | 12106237 | Behcet's syndrome | |
| 121062373 | 12106237 | Cystitis | |
| 121062373 | 12106237 | Diarrhoea | |
| 121062373 | 12106237 | Enterocolitis viral | |
| 121062373 | 12106237 | Faeces soft | |
| 121062373 | 12106237 | Gastrointestinal disorder | |
| 121062373 | 12106237 | Intestinal perforation | |
| 121062373 | 12106237 | Rhinorrhoea | |
| 121062373 | 12106237 | Upper respiratory tract infection | |
| 121062373 | 12106237 | Vomiting | |
| 121062373 | 12106237 | Vulvovaginal candidiasis |
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 |
|---|---|---|---|---|---|---|
| 121062373 | 12106237 | 1 | 20130717 | 20130717 | 0 | |
| 121062373 | 12106237 | 2 | 20130731 | 20130731 | 0 | |
| 121062373 | 12106237 | 3 | 20130814 | 20141008 | 0 | |
| 121062373 | 12106237 | 4 | 20130727 | 0 | ||
| 121062373 | 12106237 | 5 | 20131009 | 0 | ||
| 121062373 | 12106237 | 6 | 20131220 | 0 | ||
| 121062373 | 12106237 | 7 | 20140312 | 20140326 | 0 | |
| 121062373 | 12106237 | 8 | 20140314 | 20140317 | 0 | |
| 121062373 | 12106237 | 9 | 20130813 | 20130813 | 0 | |
| 121062373 | 12106237 | 10 | 20130814 | 20130924 | 0 | |
| 121062373 | 12106237 | 11 | 20130925 | 20131022 | 0 | |
| 121062373 | 12106237 | 12 | 20131023 | 20131201 | 0 | |
| 121062373 | 12106237 | 13 | 20131202 | 20131220 | 0 | |
| 121062373 | 12106237 | 14 | 20131221 | 20131221 | 0 | |
| 121062373 | 12106237 | 15 | 20131226 | 20140727 | 0 | |
| 121062373 | 12106237 | 16 | 20140728 | 20140901 | 0 | |
| 121062373 | 12106237 | 17 | 20140902 | 20141014 | 0 |