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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118119403 | 11811940 | 3 | F | 201501 | 20160818 | 20151208 | 20160824 | EXP | PHHY2015BR094913 | NOVARTIS | 17.60 | YR | M | Y | 42.00000 | KG | 20160824 | MD | COUNTRY NOT SPECIFIED | BR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118119403 | 11811940 | 1 | PS | EXJADE | DEFERASIROX | 1 | Oral | 1 DF OF 500 MG (10 MG/KG), QD | 21882 | 10 | MG/KG | DISPERSIBLE TABLET | QD | ||||||
| 118119403 | 11811940 | 2 | SS | EXJADE | DEFERASIROX | 1 | Oral | 2 DF OF 500 MG (20 MG/KG), QD | 52016 | 21882 | 20 | MG/KG | DISPERSIBLE TABLET | QD | |||||
| 118119403 | 11811940 | 3 | SS | EXJADE | DEFERASIROX | 1 | Unknown | 1 DF OF 500 MG (10 MG/KG), QD | 21882 | 10 | MG/KG | DISPERSIBLE TABLET | QD | ||||||
| 118119403 | 11811940 | 4 | SS | HIDROXIUREA | HYDROXYUREA | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118119403 | 11811940 | 1 | Sickle cell anaemia |
| 118119403 | 11811940 | 4 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 118119403 | 11811940 | HO |
| 118119403 | 11811940 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118119403 | 11811940 | Abasia | |
| 118119403 | 11811940 | Cerebrovascular accident | |
| 118119403 | 11811940 | Dysphagia | |
| 118119403 | 11811940 | Eating disorder | |
| 118119403 | 11811940 | Fracture | |
| 118119403 | 11811940 | Haemoglobin decreased | |
| 118119403 | 11811940 | Incorrect route of drug administration | |
| 118119403 | 11811940 | Osteomyelitis | |
| 118119403 | 11811940 | Osteoporosis | |
| 118119403 | 11811940 | Paralysis | |
| 118119403 | 11811940 | Serum ferritin increased | |
| 118119403 | 11811940 | Skin ulcer | |
| 118119403 | 11811940 | Urinary tract infection | |
| 118119403 | 11811940 | Weight decreased |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |