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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127955311 | 12795531 | 1 | I | 201510 | 20160922 | 20160929 | 20160929 | EXP | FR-UCBSA-2016036928 | UCB | 34.02 | YR | F | Y | 0.00000 | 20160929 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127955311 | 12795531 | 1 | PS | CIMZIA | CERTOLIZUMAB PEGOL | 1 | Subcutaneous | 1 DF, WEEKLY (QW) | N | U | 125160 | 1 | DF | SOLUTION FOR INJECTION | /wk | ||||
| 127955311 | 12795531 | 2 | SS | Biprofenid | KETOPROFEN | 1 | Oral | UNK | N | U | 0 | ||||||||
| 127955311 | 12795531 | 3 | SS | SALAZOPYRINE | SULFASALAZINE | 1 | Oral | 2 DF, 3X/DAY (TID) | 0 | 2 | DF | TID | |||||||
| 127955311 | 12795531 | 4 | SS | INIPOMP | PANTOPRAZOLE SODIUM | 1 | Oral | 1 DF, ONCE DAILY (QD) | N | U | 0 | 1 | DF | GASTRO-RESISTANT TABLET | QD | ||||
| 127955311 | 12795531 | 5 | SS | LANSOPRAZOLE. | LANSOPRAZOLE | 1 | Oral | UNK | 0 | ||||||||||
| 127955311 | 12795531 | 6 | C | Uvedose | CHOLECALCIFEROL | 1 | UNK | U | 0 | ||||||||||
| 127955311 | 12795531 | 7 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | UNK | U | 0 | ||||||||||
| 127955311 | 12795531 | 8 | C | TRAMADOL. | TRAMADOL | 1 | UNK | U | 0 | ||||||||||
| 127955311 | 12795531 | 9 | C | Nefopam | NEFOPAM | 1 | UNK | U | 0 | ||||||||||
| 127955311 | 12795531 | 10 | C | Nefopam | NEFOPAM | 1 | DAILY | U | 0 | ||||||||||
| 127955311 | 12795531 | 11 | C | Ludeal | ETHINYL ESTRADIOLLEVONORGESTREL | 1 | UNK | U | 0 | ||||||||||
| 127955311 | 12795531 | 12 | C | SIMPONI | GOLIMUMAB | 1 | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127955311 | 12795531 | 1 | Ankylosing spondylitis |
| 127955311 | 12795531 | 2 | Ankylosing spondylitis |
| 127955311 | 12795531 | 3 | Ankylosing spondylitis |
| 127955311 | 12795531 | 4 | Prophylaxis against gastrointestinal ulcer |
| 127955311 | 12795531 | 5 | Prophylaxis against gastrointestinal ulcer |
| 127955311 | 12795531 | 6 | Product used for unknown indication |
| 127955311 | 12795531 | 7 | Product used for unknown indication |
| 127955311 | 12795531 | 8 | Product used for unknown indication |
| 127955311 | 12795531 | 9 | Product used for unknown indication |
| 127955311 | 12795531 | 11 | Product used for unknown indication |
| 127955311 | 12795531 | 12 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127955311 | 12795531 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127955311 | 12795531 | Off label use | |
| 127955311 | 12795531 | Renal failure | |
| 127955311 | 12795531 | Tubulointerstitial nephritis |
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 |
|---|---|---|---|---|---|---|
| 127955311 | 12795531 | 1 | 201510 | 201609 | 0 | |
| 127955311 | 12795531 | 2 | 201302 | 201608 | 0 | |
| 127955311 | 12795531 | 3 | 201302 | 0 | ||
| 127955311 | 12795531 | 4 | 201302 | 201606 | 0 | |
| 127955311 | 12795531 | 5 | 201607 | 0 | ||
| 127955311 | 12795531 | 7 | 20160615 | 0 | ||
| 127955311 | 12795531 | 8 | 201606 | 0 | ||
| 127955311 | 12795531 | 9 | 2016 | 2016 | 0 | |
| 127955311 | 12795531 | 10 | 20160831 | 0 | ||
| 127955311 | 12795531 | 11 | 201608 | 0 | ||
| 127955311 | 12795531 | 12 | 201406 | 201510 | 0 |