Example 2b. Reported Side Effects at 12-Months for Active and Placebo Groups in TOMHS
Active Group
Placebo Group
P-Value
Condition
No. Cond
Percent
No. Cond
Percent
Drowsiness
78
12.3
24
10.7
0.551
Tiredness
112
17.7
55
24.4
0.031
Faintness
50
7.9
18
8.0
1.000
Itchy Skin
79
12.5
24
10.7
0.551
Skin Rash
55
8.7
18
8.0
0.889
Headaches
136
21.5
52
23.1
0.639
Ringing in Ears
86
13.6
31
13.8
0.910
Stuffy Nose
168
26.5
64
28.4
0.600
Dry Mouth
44
6.9
17
7.6
0.763
Cough
69
10.9
28
12.4
0.541
Fast Heart Rate
46
7.3
16
7.1
1.000
Chest Pain
43
6.8
23
10.2
0.109
Joint Pain
187
29.5
69
30.7
0.735
Swelling Feet
38
6.0
16
7.1
0.527
Muscle Cramps
84
13.2
38
16.9
0.183
Numbness
66
10.4
27
12.0
0.533
Trouble Sleeping
65
10.3
23
10.2
1.000
Waking up Early
107
16.9
40
17.8
0.758
Mood Changes
43
6.8
22
9.8
0.145
Depressed
76
12.0
26
11.6
0.905
Number of Participants
634
225
Notes: P-values based on Fishers exact test
pn=example2b rundate=31AUG2018