Table 1.
Total hospitalizations by treatment group and by MedDRA System Organ Class category
| Physical Activity (N=807) | Health Education (N=811) | |||||||
|---|---|---|---|---|---|---|---|---|
| MedDRA System Organ Class | Participants (% of participants) |
Total Events |
Events per participant year (95% CI) |
Particip ants (% of particip ants) |
Tot al Eve nts |
Events per participant year (95% CI) |
Difference In % of Participan ts (95% CL) |
Rate Ratio (95% CI) |
| ALL Inpatient Hospitalizations | 396 (49.1%) | 777 |
0.378 (0.340,
0.419) |
360
(44.4%) |
681 |
0.324 (0.291,
0.361) |
−4.68 (−
9.54, 0.18) |
1.16 (1.00,
1.35) |
| Blood And Lymphatic System Disorders | 11 (1.4%) | 16 |
0.009 (0.004,
0.022) |
9 (1.1%) | 12 |
0.006 (0.003,
0.014) |
−0.25 (−
1.33, 0.82) |
1.45 (0.44,
4.78) |
| Cardiac Disorders | 77 (9.5%) | 116 |
0.054 (0.042,
0.070) |
70
(8.6%) |
97 |
0.045 (0.034,
0.060) |
−0.91 (−
3.71, 1.89) |
1.21 (0.83,
1.76) |
| Ear And Labyrinth Disorders | 5 (0.6%) | 5 |
0.002 (0.001,
0.006) |
6 (0.7%) | 6 |
0.003 (0.001,
0.006) |
0.12 (−4.72,
4.97) |
0.84 (0.26,
2.76) |
| Endocrine Disorders | 4 (0.5%) | 5 |
0.002 (0.001,
0.006) |
1 (0.1%) | 1 |
0.000 (0.000,
0.003) |
−0.37 (−
5.21, 4.48) |
5.05 (0.59,
43.26) |
| Gastrointestinal Disorders | 59 (7.3%) | 81 |
0.038 (0.029,
0.050) |
47
(5.8%) |
53 |
0.025 (0.018,
0.034) |
−1.52 (−
3.93, 0.90) |
1.50 (0.99,
2.28) |
| General Disorders And Administration Site Conditions |
19 (2.4%) | 24 |
0.011 (0.006,
0.017) |
19 (2.3%) | 21 |
0.009 (0.005,
0.015) |
−0.01 (−
1.49, 1.46) |
1.16 (0.58,
2.32) |
| Hepatobiliary Disorders | 8 (1.0%) | 9 |
0.004 (0.002,
0.010) |
6 (0.7%) | 7 |
0.003 (0.001,
0.008) |
−0.25 (−
1.15, 0.65) |
1.29 (0.36,
4.70) |
| Immune System Disorders | 5 (0.6%) | 7 |
0.003 (0.001,
0.008) |
3 (0.4%) | 3 |
0.001 (0.000,
0.005) |
−0.24 (−
5.09, 4.60) |
2.44 (0.48,
12.40) |
| Infections And Infestations | 61 (7.6%) | 73 |
0.035 (0.027,
0.045) |
49
(6.0%) |
57 |
0.027 (0.020,
0.035) |
−1.52 (−
3.97, 0.94) |
1.30 (0.88,
1.93) |
| Injury, Poisoning And Procedural Complications |
54 (6.7%) | 58 |
0.027 (0.021,
0.036) |
56
(6.9%) |
63 |
0.029 (0.023,
0.038) |
0.21 (−2.24,
2.67) |
0.93 (0.64,
1.36) |
| Investigations | 3 (0.4%) | 4 |
0.002 (0.001,
0.005) |
2 (0.2%) | 2 |
0.001 (0.000,
0.004) |
−0.12 (−
4.97, 4.72) |
2.02 (0.37,
11.03) |
| Metabolism And Nutrition Disorders | 22 (2.7%) | 25 |
0.012 (0.008,
0.017) |
21
(2.6%) |
21 |
0.010 (0.006,
0.015) |
−0.14 (−
1.70, 1.43) |
1.20 (0.67,
2.15) |
| Musculoskeletal And Connective Tissue Disorders |
50 (6.2%) | 54 |
0.025 (0.019,
0.034) |
55
(6.8%) |
64 |
0.029 (0.022,
0.038) |
0.59 (−1.81,
2.99) |
0.87 (0.59,
1.29) |
| Neoplasms Benign, Malignant And Unspecified (Incl Cysts And Polyps) |
17 (2.1%) | 17 |
0.008 (0.005,
0.014) |
17
(2.1%) |
20 |
0.009 (0.006,
0.015) |
−0.01 (−
1.41, 1.39) |
0.87 (0.43,
1.76) |
| Nervous System Disorders | 67 (8.3%) | 83 |
0.039 (0.030,
0.051) |
55
(6.8%) |
66 |
0.031 (0.024,
0.041) |
−1.52 (−
4.09, 1.05) |
1.26 (0.86,
1.85) |
| Psychiatric Disorders | 7 (0.9%) | 7 |
0.003 (0.001,
0.007) |
3 (0.4%) | 3 |
0.001 (0.000,
0.004) |
−0.49 (−
5.33, 4.36) |
2.34 (0.61,
9.07) |
| Renal And Urinary Disorders | 14 (1.7%) | 15 |
0.006 (0.004,
0.011) |
16
(2.0%) |
16 |
0.007 (0.004,
0.011) |
0.24 (−1.08,
1.55) |
0.94 (0.46,
1.90) |
| Reproductive System And Breast Disorders | 4 (0.5%) | 4 |
0.002 (0.001,
0.005) |
3 (0.4%) | 3 |
0.001 (0.000,
0.004) |
−0.12 (−
4.97, 4.72) |
1.35 (0.30,
6.03) |
| Respiratory, Thoracic And Mediastinal Disorders |
48 (5.9%) | 60 |
0.030 (0.022,
0.042) |
36
(4.4%) |
44 |
0.021 (0.015,
0.031) |
−1.51 (−
3.67, 0.65) |
1.43 (0.87,
2.33) |
| Skin And Subcutaneous Tissue Disorders | 2 (0.2%) | 2 |
0.001 (0.000,
0.004) |
7
(0.9%) |
9 |
0.004 (0.002,
0.010) |
0.61 (−4.23,
5.45) |
0.22 (0.04,
1.19) |
| Surgical And Medical Procedures | 68 (8.4%) | 76 |
0.036 (0.028,
0.046) |
73
(9.0%) |
84 |
0.039 (0.031,
0.049) |
0.57 (−2.17,
3.32) |
0.91 (0.65,
1.28) |
| Vascular Disorders | 33 (4.1%) | 36 |
0.017 (0.011,
0.025) |
26
(3.2%) |
29 |
0.014 (0.009,
0.021) |
−0.88 (−
2.71, 0.94) |
1.25 (0.69,
2.29) |