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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121938337 | 12193833 | 7 | F | 2016 | 20160704 | 20160321 | 20160708 | EXP | IE-AMGEN-IRLSL2016033753 | AMGEN | 63.00 | YR | A | F | Y | 0.00000 | 20160708 | MD | IE | IE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121938337 | 12193833 | 1 | PS | PROLIA | DENOSUMAB | 1 | Intramuscular | 60 MG, UNK | Y | 125320 | 60 | MG | SOLUTION FOR INJECTION | ||||||
| 121938337 | 12193833 | 2 | SS | DICLAC | DICLOFENAC | 1 | Oral | 150 MG, QD | 0 | 150 | MG | QD | |||||||
| 121938337 | 12193833 | 3 | C | FOLIC ACID. | FOLIC ACID | 1 | 10 MG, QWK | 0 | 10 | MG | /wk | ||||||||
| 121938337 | 12193833 | 4 | C | METHOTREXATE. | METHOTREXATE | 1 | 12.5 MG, QWK | 0 | 12.5 | MG | /wk | ||||||||
| 121938337 | 12193833 | 5 | C | IDEOS | CALCIUM CARBONATECHOLECALCIFEROL | 1 | Oral | 1 IN 1 D | 0 | ||||||||||
| 121938337 | 12193833 | 6 | C | PNEUMOCOCCAL VACCINE POLYVALENT NOS | PNEUMOCOCCAL VACCINE POLYVALENT | 1 | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121938337 | 12193833 | 1 | Osteoporosis |
| 121938337 | 12193833 | 2 | Arthralgia |
| 121938337 | 12193833 | 3 | Rheumatoid arthritis |
| 121938337 | 12193833 | 4 | Rheumatoid arthritis |
| 121938337 | 12193833 | 5 | Osteoporosis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 121938337 | 12193833 | OT |
| 121938337 | 12193833 | LT |
| 121938337 | 12193833 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121938337 | 12193833 | Abdominal pain upper | |
| 121938337 | 12193833 | Arthralgia | |
| 121938337 | 12193833 | Diarrhoea | |
| 121938337 | 12193833 | Faeces discoloured | |
| 121938337 | 12193833 | Fatigue | |
| 121938337 | 12193833 | Feeling abnormal | |
| 121938337 | 12193833 | Gait disturbance | |
| 121938337 | 12193833 | Haematemesis | |
| 121938337 | 12193833 | Injection site erythema | |
| 121938337 | 12193833 | Injection site pain | |
| 121938337 | 12193833 | Injection site swelling | |
| 121938337 | 12193833 | Internal haemorrhage | |
| 121938337 | 12193833 | Joint swelling | |
| 121938337 | 12193833 | Pain | |
| 121938337 | 12193833 | Syncope |
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 |
|---|---|---|---|---|---|---|
| 121938337 | 12193833 | 1 | 20160208 | 20160209 | 0 | |
| 121938337 | 12193833 | 2 | 20160209 | 0 | ||
| 121938337 | 12193833 | 3 | 2004 | 0 | ||
| 121938337 | 12193833 | 4 | 2004 | 0 | ||
| 121938337 | 12193833 | 5 | 2004 | 0 | ||
| 121938337 | 12193833 | 6 | 20160208 | 0 |