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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122427503 | 12242750 | 3 | F | 20140408 | 20160713 | 20160406 | 20160722 | EXP | JP-UCBSA-2016011837 | UCB | 60.75 | YR | F | Y | 51.00000 | KG | 20160722 | MD | JP | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122427503 | 12242750 | 1 | PS | Certolizumab pegol RA | CERTOLIZUMAB PEGOL | 1 | Subcutaneous | 400 MG, EV 2 WEEKS(QOW) | Y | U | 125160 | 400 | MG | SOLUTION FOR INJECTION | QOW | ||||
| 122427503 | 12242750 | 2 | SS | Certolizumab pegol RA | CERTOLIZUMAB PEGOL | 1 | Subcutaneous | 200 MG, EV 2 WEEKS(QOW) | Y | U | 125160 | 200 | MG | SOLUTION FOR INJECTION | QOW | ||||
| 122427503 | 12242750 | 3 | SS | Certolizumab pegol RA | CERTOLIZUMAB PEGOL | 1 | Subcutaneous | 200 MG, EV 2 WEEKS(QOW) | Y | U | 125160 | 200 | MG | SOLUTION FOR INJECTION | QOW | ||||
| 122427503 | 12242750 | 4 | SS | METHOTREXATE. | METHOTREXATE | 1 | Oral | 12 MG, WEEKLY (QW) | Y | U | 0 | 12 | MG | /wk | |||||
| 122427503 | 12242750 | 5 | SS | METHOTREXATE. | METHOTREXATE | 1 | Oral | 10 MG, WEEKLY (QW) | Y | U | 0 | 10 | MG | /wk | |||||
| 122427503 | 12242750 | 6 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 4 MG/DAY | 0 | ||||||||||
| 122427503 | 12242750 | 7 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 3 MG/DAY | 0 | ||||||||||
| 122427503 | 12242750 | 8 | C | DICLOFENAC SODIUM. | DICLOFENAC SODIUM | 1 | Oral | 37.5 MG DAILY | U | 0 | |||||||||
| 122427503 | 12242750 | 9 | C | Foliamin | FOLIC ACID | 1 | Oral | 5 MG, DAILY | U | 0 | 5 | MG | |||||||
| 122427503 | 12242750 | 10 | C | Artist | CARVEDILOL | 1 | Oral | 5 MG DAILY | U | 0 | |||||||||
| 122427503 | 12242750 | 11 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | Oral | 10 MG DAILY | U | 0 | |||||||||
| 122427503 | 12242750 | 12 | C | Toyofarol | ALFACALCIDOL | 1 | Oral | 1 ?G DAILY | U | 0 | |||||||||
| 122427503 | 12242750 | 13 | C | Acinon | NIZATIDINE | 1 | Oral | 150 MG DAILY | U | 0 | |||||||||
| 122427503 | 12242750 | 14 | C | Benet | RISEDRONATE SODIUM | 1 | Oral | 17.5 MG DAILY | U | 0 | |||||||||
| 122427503 | 12242750 | 15 | C | Loxonin | LOXOPROFEN SODIUM | 1 | Transdermal | UNK | U | 0 | |||||||||
| 122427503 | 12242750 | 16 | C | ALLOID G | SODIUM ALGINATE | 1 | Oral | 60 ML DAILY | U | 0 | |||||||||
| 122427503 | 12242750 | 17 | C | Adona | CARBAZOCHROME SODIUM SULFONATE | 1 | 100 MG DAILY | U | 0 | ||||||||||
| 122427503 | 12242750 | 18 | C | Takepron | LANSOPRAZOLE | 1 | Oral | 15 MG DAILY | U | 0 | |||||||||
| 122427503 | 12242750 | 19 | C | Acetated ringer | 2 | 1500 ML/DAY | U | 0 | |||||||||||
| 122427503 | 12242750 | 20 | C | Antibiotics-resistant lactic acid bacteriae | UNSPECIFIED INGREDIENT | 1 | 3 PACKS/DAY | U | 0 | ||||||||||
| 122427503 | 12242750 | 21 | C | ALBUMIN TANNATE | ALBUMIN BOVINETANNIC ACID | 1 | 3 G/DAY | U | 0 | ||||||||||
| 122427503 | 12242750 | 22 | C | KETOCONAZOLE. | KETOCONAZOLE | 1 | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122427503 | 12242750 | 1 | Rheumatoid arthritis |
| 122427503 | 12242750 | 4 | Rheumatoid arthritis |
| 122427503 | 12242750 | 6 | Rheumatoid arthritis |
| 122427503 | 12242750 | 8 | Rheumatoid arthritis |
| 122427503 | 12242750 | 9 | Prophylaxis |
| 122427503 | 12242750 | 10 | Product used for unknown indication |
| 122427503 | 12242750 | 11 | Product used for unknown indication |
| 122427503 | 12242750 | 12 | Product used for unknown indication |
| 122427503 | 12242750 | 13 | Prophylaxis |
| 122427503 | 12242750 | 14 | Product used for unknown indication |
| 122427503 | 12242750 | 15 | Product used for unknown indication |
| 122427503 | 12242750 | 16 | Prophylaxis |
| 122427503 | 12242750 | 17 | Endoscopy upper gastrointestinal tract |
| 122427503 | 12242750 | 18 | Prophylaxis |
| 122427503 | 12242750 | 19 | Pyelonephritis acute |
| 122427503 | 12242750 | 20 | Enterocolitis |
| 122427503 | 12242750 | 21 | Enterocolitis |
| 122427503 | 12242750 | 22 | Tinea infection |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122427503 | 12242750 | OT |
| 122427503 | 12242750 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122427503 | 12242750 | Cataract | |
| 122427503 | 12242750 | Cystitis | |
| 122427503 | 12242750 | Enterocolitis | |
| 122427503 | 12242750 | Pyelonephritis acute | |
| 122427503 | 12242750 | Tinea 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 |
|---|---|---|---|---|---|---|
| 122427503 | 12242750 | 1 | 20131114 | 20131212 | 0 | |
| 122427503 | 12242750 | 2 | 20131226 | 20140403 | 0 | |
| 122427503 | 12242750 | 3 | 20140516 | 0 | ||
| 122427503 | 12242750 | 4 | 20140710 | 0 | ||
| 122427503 | 12242750 | 5 | 20140711 | 0 | ||
| 122427503 | 12242750 | 6 | 20131212 | 0 | ||
| 122427503 | 12242750 | 7 | 20131212 | 20141127 | 0 | |
| 122427503 | 12242750 | 8 | 20150402 | 0 | ||
| 122427503 | 12242750 | 12 | 20140411 | 0 | ||
| 122427503 | 12242750 | 13 | 20140515 | 0 | ||
| 122427503 | 12242750 | 15 | 20140502 | 0 | ||
| 122427503 | 12242750 | 16 | 20140414 | 20140502 | 0 | |
| 122427503 | 12242750 | 17 | 20140422 | 20140422 | 0 | |
| 122427503 | 12242750 | 18 | 20140516 | 0 | ||
| 122427503 | 12242750 | 19 | 20140411 | 20140418 | 0 | |
| 122427503 | 12242750 | 20 | 20140411 | 20140506 | 0 | |
| 122427503 | 12242750 | 21 | 20140414 | 20140416 | 0 | |
| 122427503 | 12242750 | 22 | 20140711 | 20140905 | 0 |