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Eudravigilance voorbeeld Oracle BI Interactive Dashboards - DAP.pdf

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Oracle BI Interactive Dashboards - DAP Number of Individual Cases by EEA countries

Number of Individual Cases By Reaction Groups

Number of Individual Cases for a selected Reaction Group

Number of Individual Cases for a selected Reaction

Line Listing

Choose a Reaction Group and then a Reported Suspected Reaction to see the number of individual cases identified in EudraVigilance for TOZINAMERAN (up to 11/06/2022) Number of individual cases by Age Group & Sex, Reporter Group and Outcome

Reaction Groups & Reported Suspected Reaction Reaction Groups Blood and lymphatic system disorders

Age Group & Sex

Not Specified 0-1 Month 2 Months - 2 Years 3-11 Years 12-17 Years 18-64 Years 65-85 Years More than 85 Years 0

10

20

30

40

50

60

70

Number of individual cases

Reporter Group

Female

Male

Not Specified

Healthcare Professional

81

Non Healthcare Professional

11

Not Specified

0 0

15

30

45

60

75

90

Number of individual cases

12

Fatal

13

Not Recovered/Not Resolved

Outcome

Reported Suspected Reaction ate et so de Platelet dysfunction Platelet production decreased Poikilocytosis Polychromasia Polycythaemia Post-anaphylaxis mast cell anergy Protein deficiency anaemia Pseudolymphoma Purpura non-thrombocytopenic Red blood cell abnormality Reticulocytosis Reticuloendothelial dysfunction Retroperitoneal lymphadenopathy Sarcoidosis of lymph node Secondary thrombocytosis Sickle cell anaemia with crisis Spleen atrophy Spleen disorder Spleen ischaemia Splenic artery thrombosis Splenic cyst Splenic embolism Splenic granuloma Splenic haematoma Splenic haemorrhage Splenic infarction Splenic lesion Splenic necrosis Splenic thrombosis Splenic vein thrombosis Splenitis Splenomegaly Spontaneous haematoma Spontaneous haemorrhage Spur cell anaemia Stress polycythaemia Thrombocytopenia Thrombocytopenic purpura Thrombocytosis Thrombosis with thrombocytopenia syndrome Thrombotic microangiopathy Thrombotic thrombocytopenic purpura Thymus disorder Thymus enlargement Warm autoimmune haemolytic anaemia White blood cell disorder

0

Not Specified

12

Recovered/Resolved 5

Recovered/Resolved With Sequelae

35

Recovering/Resolving 15

Unknown 0

5

10

15

20

25

30

35

40

Number of individual cases

https://dap.ema.europa.eu/analytics/saw.dll?PortalPages

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