An Open-Label, Noncomparative, Multicenter Study to Evaluate Efficacy and Safety of NASHA/Dx Gel as a Bulking Agent for the Treatment of Fecal Incontinence
Table 4
Related AEs with an incidence of >3 events by MedDRA preferred term: safety population.
MedDRA preferred term
Number of events
Maximal intensity
Median time to onset
Median duration
Method of intervention*
Proportion of events resolved
Mild
Moderate
Severe
None required
Medical treatment
Other
Adominal pain
3
1
2
0
1.0
8.0
1
2
0
100%
Constipation
5
4
1
0
2.0
3.0
1
4
0
100%
Diarrhea
5
2
3
0
1.0
8.0
3
2
0
100%
Injection site pain
4
2
2
0
1.0
3.0
0
4
0
100%
Perineal pain
3
1
2
0
1.0
6.0
1
2
0
100%
Proctalgia
15
7
7
1
0.0
5.0
9
5
1*
100%
Pyrexia
8
3
4
1
1.0
3.5
2
6
0
100%
Rectal hemorrhage
3
2
1
0
13.0
4.0
2
0
1*
100%
Rectal tenesmus
3
3
0
0
0.0
8.0
3
0
0
100%
MedDRA: medical dictionary of regulatory authorities.
*One event each of proctalgia and rectal hemorrhage were coinciding events with a rectal prolapse that was treated in surgery.
