Table 2.
Summary of outcomes categorised according to the COMET taxonomy
| Core area | Core domains | Trials including one or more outcome in core domain (n (%)) | Outcomes included in core domain (n (%)) | Trials including as a primary outcomea (n) |
|---|---|---|---|---|
| Death | Mortality/survival | 3 (2.2) | 3 (0.2) | 0 |
| Physiological/clinical | Blood and lymphatic system outcomes | 9 (6.5) | 19 (1.3) | 1 |
| Cardiac outcomes | 20 (14.5) | 56 (3.9) | 9 | |
| Congenital, familial and genetic outcomes | 0(0) | 0 (0) | ||
| Endocrine outcomes | 31(22.5) | 50 (3.5) | 7 | |
| Ear and labyrinth outcomes | 0 (0) | 0 (0) | 0 | |
| Eye outcomes | 2 (1.4) | 2 (0.1) | 0 | |
| Gastrointestinal outcomes | 5 (3.6) | 20 (1.4) | 2 | |
| General outcomes | 65 (47.1) | 146 (10.1) | 3 | |
| Hepatobiliary outcomes | 12 (8.7) | 25 (1.7) | 3 | |
| Immune system outcomes | 28 (20.3) | 73 (5.1) | 4 | |
| Infection and infestation outcomes | 4 (2.9) | 8 (0.6) | 0 | |
| Injury and poisoning outcomes | 0 (0) | 0 (0) | 0 | |
| Metabolism and nutrition outcomes | 121 (87.7) | 582 (40.3) | 92 | |
| Musculoskeletal and connective tissue outcomes | 2 (1.4) | 2 (0.1) | 1 | |
| Outcomes relating to neoplasms: benign, malignant and unspecified (including cysts and polyps) | 0 (0) | 0 (0) | 0 | |
| Nervous system outcomes | 6 (4.3) | 16 (1.1) | 2 | |
| Pregnancy, puerperium and perinatal outcomes | 0 (0) | 0 (0) | 0 | |
| Renal and urinary outcomes | 27 (19.6) | 76 (5.3) | 5 | |
| Reproductive system and breast outcomes | 0 (0) | 0 (0) | 0 | |
| Psychiatric outcomes | 2 (1.4) | 2 (0.1) | 0 | |
| Respiratory, thoracic and mediastinal outcomes | 3 (2.2) | 11 (0.8) | 1 | |
| Skin and subcutaneous tissue outcomes | 1 (0.7) | 1 (0.1) | 0 | |
| Vascular outcomes | 51 (37) | 134 (9.3) | 13 | |
| Physical functioning | 5 (3.6) | 7 (0.5) | 0 | |
| Life impact | Social functioning | 5 (3.6) | 6 (0.4) | 0 |
| Role functioning | 3 (2.2) | 6 (0.4) | 0 | |
| Emotional functioning/wellbeing | 8 (5.8) | 28 (1.9) | 0 | |
| Cognitive functioning | 2 (1.4) | 22 (1.5) | 0 | |
| Global quality of life | 4 (2.9) | 5 (0.3) | 0 | |
| Perceived health status | 4 (2.9) | 4 (0.3) | 0 | |
| Delivery of care | 30 (21.7) | 60 (4.2) | 4 | |
| Personal circumstance | 0 (0) | 0 (0) | 0 | |
| Resource use | Economic | 4 (4) | 6 (0.4) | 0 |
| Hospital | 3 (2.2) | 4 (0.3) | 0 | |
| Need for intervention | 16 (11.6) | 24 (1.7) | 1 | |
| Societal/carer burden | 0 (0) | 0 (0) | 0 | |
| Adverse events | Adverse events/effects | 33 (23.9) | 46 (3.2) | 5 |
aSome trials included more than one primary outcome