Table 5 |
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|
Classification of adverse events by cause and relatedness to study intervention |
|||||
| Study Related |
Non-study Related |
||||
|
|
|||||
| Category, Freq: n (%) |
Serious |
Non-Serious Minor-Moderate |
Serious |
Non-Serious Minor-Moderate |
Total |
|
|
|||||
| Cardiovascular |
2 (1.4) |
4 (2.6) |
23 (15.8) |
45 (30.8) |
74 (50.6) |
| Musculoskeletal |
0 (0.0) |
9 (6.2) |
3 (2.1) |
15 (10.3) |
27 (18.6) |
| Metabolic-Endocrine |
0 (0.0) |
0 (0.0) |
6 (4.1) |
4 (2.6) |
10 (6.7) |
| Infectious Disease |
0 (0.0) |
3 (2.1) |
4 (2.7) |
8 (5.5) |
15 (10.3) |
| Psycho-Neurological |
0 (0.0) |
1 (0.7) |
4 (2.7) |
3 (2.1) |
8 (5.5) |
| Gastrointestinal |
0 (0.0) |
0 (0.0) |
0 (0.0) |
3 (2.1) |
3 (2.1) |
| Motor Vehicle Accident |
0 (0.0) |
0 (0.0) |
2 (1.4) |
1 (0.7) |
3 (2.1) |
| Surgical |
0 (0.0) |
0 (0.0) |
4 (2.7) |
2 (1.4) |
6 (4.1) |
|
|
|||||
| Total |
2 (1.4) |
17 (11.6) |
46 (31.5) |
81 (55.5) |
146 (100.0) |
|
|
|||||
|
Note. Serious AE's were defined consistent with most IRB definitions as a 1) death; 2) a life threatening experience; 3) hospitalization or prolongation of hospitalization; 4) persistent significant disability or incapacity; or 5) an event that jeopardizes the subject and may require medical or surgical treatment to prevent one of the preceding outcomes. Non-serious AE's consisted of both minor and moderately serious AE's. Moderately serious AE's were defined as concerning new medical symptoms (not imminently life threatening) or acute events that either required suspension until clearance by a physician to rule out potential for Serious AE's (cardiopulmonary dysfunction) and insure optimal patient self-care (e.g., medication, blood pressure, or blood sugar regulation) or, events causing voluntary cessation of walking by the participant until the aggravating event passed (e.g., illness, serious musculoskeletal injury, motor vehicle accident). Minor AE's were defined as events not necessitating study suspension and causing minor discomfort or inconvenience to the participant as a result of study participation (e.g., sore muscles, blisters, equipment malfunction). |
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|
Goodrich et al. International Journal of Behavioral Nutrition and Physical Activity 2007 4:20 doi:10.1186/1479-5868-4-20 |
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