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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113972242 | 11397224 | 2 | F | 2015 | 20160810 | 20150819 | 20160817 | EXP | CA-UCBSA-2015026162 | UCB | 65.03 | YR | F | Y | 0.00000 | 20160817 | OT | CA | CA |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113972242 | 11397224 | 1 | PS | Certolizumab pegol RA | CERTOLIZUMAB PEGOL | 1 | Subcutaneous | 400 MG, EV 2 WEEKS(QOW) | Y | 125160 | 400 | MG | QOW | ||||||
| 113972242 | 11397224 | 2 | SS | Certolizumab pegol RA | CERTOLIZUMAB PEGOL | 1 | Subcutaneous | 200 MG, EV 2 WEEKS(QOW) | Y | 125160 | 200 | MG | QOW | ||||||
| 113972242 | 11397224 | 3 | SS | PREDNISONE. | PREDNISONE | 1 | 60 MG; 5 DAYS | U | U | 0 | |||||||||
| 113972242 | 11397224 | 4 | SS | PREDNISONE. | PREDNISONE | 1 | 5 MG X 15 DAYS | U | U | 0 | |||||||||
| 113972242 | 11397224 | 5 | C | SPIRIVA | TIOTROPIUM BROMIDE MONOHYDRATE | 1 | UNK | U | 0 | ||||||||||
| 113972242 | 11397224 | 6 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | Oral | 10 MG, ONCE DAILY (QD) | U | 0 | 10 | MG | QD | ||||||
| 113972242 | 11397224 | 7 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | Oral | 0.075 MG, ONCE DAILY (QD) | U | 0 | .075 | MG | QD | ||||||
| 113972242 | 11397224 | 8 | C | Cilazapril | CILAZAPRIL ANHYDROUS | 1 | Oral | 5 MG, 2X/DAY (BID) | U | 0 | 5 | MG | BID | ||||||
| 113972242 | 11397224 | 9 | C | NIZATIDINE. | NIZATIDINE | 1 | Oral | 150 MG, 2X/DAY (BID) | U | 0 | 150 | MG | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 113972242 | 11397224 | 1 | Rheumatoid arthritis |
| 113972242 | 11397224 | 3 | Product used for unknown indication |
| 113972242 | 11397224 | 5 | Product used for unknown indication |
| 113972242 | 11397224 | 6 | Hypertension |
| 113972242 | 11397224 | 7 | Hypothyroidism |
| 113972242 | 11397224 | 8 | Hypertension |
| 113972242 | 11397224 | 9 | Gastrooesophageal reflux disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 113972242 | 11397224 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 113972242 | 11397224 | Muscle spasms | |
| 113972242 | 11397224 | Pneumonia |
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 |
|---|---|---|---|---|---|---|
| 113972242 | 11397224 | 1 | 20121211 | 20130108 | 0 | |
| 113972242 | 11397224 | 2 | 20130122 | 20150921 | 0 | |
| 113972242 | 11397224 | 4 | 20150803 | 0 |