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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 951867813 | 9518678 | 13 | F | 201209 | 20160725 | 20130912 | 20160729 | EXP | PHHY2013BR100414 | NOVARTIS | 17.31 | YR | M | Y | 62.00000 | KG | 20160729 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 951867813 | 9518678 | 1 | PS | EXJADE | DEFERASIROX | 1 | Oral | 10 MG/KG, QD (2 DF OF 250 MG) | 21882 | 10 | MG/KG | DISPERSIBLE TABLET | QD | ||||||
| 951867813 | 9518678 | 2 | SS | EXJADE | DEFERASIROX | 1 | Oral | 15 MG/KG, QD (1000 MG) | 21882 | 15 | MG/KG | DISPERSIBLE TABLET | QD | ||||||
| 951867813 | 9518678 | 3 | SS | EXJADE | DEFERASIROX | 1 | Oral | 25 MG/KG, QD (3 DF OF 500 MG) | 21882 | 25 | MG/KG | DISPERSIBLE TABLET | QD | ||||||
| 951867813 | 9518678 | 4 | C | AAS | ASPIRIN | 1 | Oral | 1 DF, QD | Y | 0 | 1 | DF | QD | ||||||
| 951867813 | 9518678 | 5 | C | FOLIC ACID. | FOLIC ACID | 1 | Oral | 5 MG, QD | 0 | 5 | MG | QD | |||||||
| 951867813 | 9518678 | 6 | C | ZOLOFT | SERTRALINE HYDROCHLORIDE | 1 | Unknown | 0 | |||||||||||
| 951867813 | 9518678 | 7 | C | DRAMAMINE | DIMENHYDRINATE | 1 | Unknown | U | 0 | ||||||||||
| 951867813 | 9518678 | 8 | C | ALENDRONATE | ALENDRONATE SODIUM | 1 | Unknown | 0 | |||||||||||
| 951867813 | 9518678 | 9 | C | DESFERAL | DEFEROXAMINE MESYLATE | 1 | Unknown | U | 0 | ||||||||||
| 951867813 | 9518678 | 10 | C | HYDREA | HYDROXYUREA | 1 | Oral | 3 DF, QD | 0 | 3 | DF | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 951867813 | 9518678 | 1 | Sickle cell anaemia |
| 951867813 | 9518678 | 4 | Product used for unknown indication |
| 951867813 | 9518678 | 5 | Sickle cell anaemia |
| 951867813 | 9518678 | 6 | Product used for unknown indication |
| 951867813 | 9518678 | 7 | Product used for unknown indication |
| 951867813 | 9518678 | 8 | Product used for unknown indication |
| 951867813 | 9518678 | 9 | Product used for unknown indication |
| 951867813 | 9518678 | 10 | Sickle cell anaemia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 951867813 | 9518678 | HO |
| 951867813 | 9518678 | OT |
| 951867813 | 9518678 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 951867813 | 9518678 | Abasia | |
| 951867813 | 9518678 | Arthralgia | |
| 951867813 | 9518678 | Aspergillus infection | |
| 951867813 | 9518678 | Back pain | |
| 951867813 | 9518678 | Bacterial infection | |
| 951867813 | 9518678 | Candida infection | |
| 951867813 | 9518678 | Cardiac disorder | |
| 951867813 | 9518678 | Contusion | |
| 951867813 | 9518678 | Dyspnoea | |
| 951867813 | 9518678 | Fall | |
| 951867813 | 9518678 | Fatigue | |
| 951867813 | 9518678 | Haemoglobin decreased | |
| 951867813 | 9518678 | Headache | |
| 951867813 | 9518678 | Hypoxia | |
| 951867813 | 9518678 | Infarction | |
| 951867813 | 9518678 | Ischaemia | |
| 951867813 | 9518678 | Lethargy | |
| 951867813 | 9518678 | Lung disorder | |
| 951867813 | 9518678 | Malaise | |
| 951867813 | 9518678 | Mental disorder | |
| 951867813 | 9518678 | Pain | |
| 951867813 | 9518678 | Pneumonia | |
| 951867813 | 9518678 | Pulmonary hypertension | |
| 951867813 | 9518678 | Pulmonary thrombosis | |
| 951867813 | 9518678 | Pyrexia | |
| 951867813 | 9518678 | Respiratory arrest | |
| 951867813 | 9518678 | Scratch | |
| 951867813 | 9518678 | Serum ferritin increased | |
| 951867813 | 9518678 | Sickle cell anaemia with crisis | |
| 951867813 | 9518678 | Tachycardia | |
| 951867813 | 9518678 | Vasoconstriction | |
| 951867813 | 9518678 | Vena cava thrombosis | |
| 951867813 | 9518678 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 951867813 | 9518678 | 1 | 20120413 | 0 | ||
| 951867813 | 9518678 | 4 | 201209 | 201309 | 0 |