Table 7 Impact of dossier evidence on DERP reports by clinical category
Clinical area | Included from dossiers | Used qualitatively | Used in MA | Gap | Confirms | Changes |
|---|---|---|---|---|---|---|
All | 160 | 142(89%) | 26 (16%) | 72 (45%) | 66 (41%) | 67 (42%) |
Cardiovascular | 3 | 3(100%) | 0 | 0 | 3(100%) | 0 |
Dermatology | 10 | 10 (100%) | 6(60%) | 3(30%) | 10 (100%) | 5(50%) |
Endocrinology | 16 | 11(69%) | 4(25%) | 8(50%) | 9(56%) | 9(56%) |
Gastrointestinal | 22 | 21(95%) | 1(5%) | 12(55%) | 6(27%) | 6(27%) |
Hepatitis | 17 | 15 (88%) | 2(12%) | 8(47%) | 7(41%) | 5(29%) |
Pain/neurology | 17 | 12(71%) | 5(29%) | 4(24%) | 11(65%) | 4(24%) |
Psychiatry | 54 | 49 (91%) | 6(11%) | 29(54%) | 15(28%) | 31(57%) |
Respiratory | 20 | 19(95%) | 1(5%) | 6(30%) | 5(25%) | 6(30%) |
Studies | 123 | |||||
Cardiovascular | 0 | – | – | – | – | |
Dermatology | 6 | 6 (100%) | 5 (83%) | 2 (33%) | 6 (100%) | 4 (67%) |
Endocrinology | 12 | 8 (67%) | 4 (33%) | 6 (50%) | 7 (58%) | 7 (58%) |
Gastrointestinal | 21 | 20 (95%) | 1 (5%) | 11 (52%) | 6 (29%) | 6 (6%) |
Hepatitis | 8 | 6 (75%) | 2 (25%) | 5 (63%) | 2 (25%) | 5 (63%) |
Neurology/pain | 11 | 6 (55%) | 5 (45%) | 1 (9%) | 7 (64%) | 2 (18%) |
Psychiatry | 46 | 41 (89%) | 6 (13%) | 26 (57%) | 14 (30%) | 27 (59%) |
Respiratory | 19 | 18 (95%) | 1(5%) | 6 (32%) | 5 (26%) | 5 (26%) |
Supplemental evidence | 37 | |||||
Cardiovascular | 3 | 3 (100%) | 0 | 0 | 3(100%) | 0 |
Dermatology | 4 | 4(100%) | 2(50%) | 1 (25%) | 4(100%) | 1 (25%) |
Endocrinology | 4 | 4(100%) | 0 | 2 (50%) | 2(50%) | 2 (50%) |
Gastrointestinal | 1 | 1 (100%) | 0 | 1(100%) | 0 | 0 |
Hepatitis | 9 | 9 (100%) | 0 | 3 (33%) | 5 (56%) | 0 |
Neurology/pain | 6 | 6 (100%) | 0 | 3(50%) | 4 (67%) | 1 (17%) |
Psychiatry | 8 | 8 (100%) | 0 | 4 (50%) | 1 (13%) | 4 (50%) |
Respiratory | 2 | 2 (100%) | 0 | 1 (50%) | 0 | 1(50%) |
Published studies | 95 | |||||
Cardiovascular | 3 | 3 (100%) | 0 | 0 | 3 (100%) | 0 |
Dermatology | 10 | 10 (100%) | 7 (70%) | 3 (30%) | 10 (100%) | 5 (50%) |
Endocrinology | 15 | 10 (67%) | 4 (27%) | 8 (53%) | 8 (53%) | 9 (60%) |
Gastrointestinal | 22 | 20 (91%) | 1 (5%) | 12 (55%) | 6 (27%) | 6 (27%) |
Hepatitis | 7 | 5 (71%) | 2 (29%) | 4 (57%) | 3(43%) | 3 (43%) |
Neurology | 5 | 4 (80%) | 1 (20%) | 2 (40%) | 2 (40%) | 3 (30%) |
Psychiatry | 24 | 21 (88%) | 2 (8%) | 10 (42%) | 8 (33%) | 8 (33%) |
Respiratory | 9 | 8 (89%) | 1 (11%) | 4 (44%) | 3 (33%) | 3 (33%) |
Unpublished evidence | 65 | |||||
Cardiovascular | 0 | – | – | – | – | |
Dermatology | 0 | – | – | – | – | – |
Endocrinology | 1 | 1 (100%) | 0 | 0 | 1(100%) | 0 |
Gastrointestinal | 0 | – | – | – | – | – |
Hepatitis | 10 | 10 (100%) | 0 | 4 (40%) | 4 (40%) | 2 (20%) |
Neurology | 12 | 8 (67%) | 4 (33%) | 2 (17%) | 9 (75%) | 1 (8%) |
Psychiatry | 30 | 27 (90%) | 4 (13%) | 20 (67%) | 7 (23%) | 23 (77%) |
Respiratory | 12 | 12 (100%) | 0 | 3 (25%) | 2 (17%) | 3 (25%) |