A CCEPTED MANUSCRIPT
Table 2. Trial adverse events overview.
Treatment
Bif195
Placebo
Total
N (%) E N (%) E N (%) E
Number of subjects
38
37
75
14 (37.8) 20
All adverse events
8 (21.1) 12
22 (29.3) 32
Back pain
1 ( 2.6) 1
0 (0) 0
1 (1.3) 1
Blocked sinuses
0 (0) 0
1 (2.7) 1
1 (1.3) 1
Chest infection
1 (2.6) 1
0 (0) 0
1 (1.3) 1
Cold and flu
0 (0) 0
1 (2.7) 1
1 (1.3) 1
Cold flu symptoms
1 (2.6) 1
0 (0) 0
1 (1.3) 1
Cold/flu symptoms including a nose bleed.
0 (0) 0
1 (2.7) 1
1 (1.3) 1
Cough, nasal congestion
0 (0) 0
1 (2.7) 1
1 (1.3) 1
Cramping in the stomach
1 (2.6) 1
0 (0) 0
1 (1.3) 1
MANUSCRIPT 1 (2.6) 1 0 (0) 0 1 (1.3) 1 1 (2.6) 1 2 (5.4) 2 3 (4.0) 3 0 (0) 0 1 (2.7) 1 1 (1.3) 1
Cystitis
Headache
Headache, sore throat, rhinorrhea.
Heartburn
0 (0) 0
2 (5.4) 2
2 (2.7) 2
Inflammation in kidneys due to kidney stones
1( 2.6) 1 0(0) 0
1 (1.3) 1
Lower abdominal pain
0 (0) 0
1 (2.7) 1
1 (1.3) 1
Nasal congestion
1 (2.6) 1
0 (0) 0
1 (1.3) 1
Nausea
1 (2.6) 1
0 (0) 0
1 (1.3) 1
Nausea, vomiting, headache, fatigue
0 (0) 0
1 (2.7) 1
1 (1.3) 1
Pain and discomfort in the stomach and gut region.
0 (0) 0
1 (2.7) 1
1 (1.3) 1
Pain and discomfort in the stomach/gut region.
1 (2.6) 1
0 (0) 0
1 (1.3) 1
Pain/discomfort in the stomach and gut region.
0 (0) 0
1 (2.7) 1
1 (1.3) 1
Painful headache which caused vomiting, thigh and back pain.
0 (0) 0
1 (2.7) 1
1 (1.3) 1
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