parallel randomized trial

S003046

Design

Arm	Treatment	Background	Randomized	Analyzed
A1	PG-102 PG-102 15 mg weekly	lifestyle: not reported	6	6
A2	PG-102 PG-102 30 mg weekly	lifestyle: not reported	6	6
A3	PG-102 PG-102 30/60 mg weekly	lifestyle: not reported	6	6
A4	Placebo Placebo	lifestyle: not reported	6	6

As printed in the trial reports or registry, per arm or for the whole trial.

Characteristic	Statistic	PG-102 15 mg weekly A1	PG-102 30 mg weekly A2	PG-102 30/60 mg weekly A3	Placebo A4
age	mean (years)	30.3	31.3	28.5	33.5
age	sd (years)	6.1	7.8	5.7	7.8
bmi	mean (kg/m2)	26.7	27.0	26.5	27.7
bmi	sd (kg/m2)	1.2	1.2	0.3	1.5
female	n	1	1	0	0
female	percent	16.7	16.7	0	0
weight	mean (kg)	77.6	80.0	81.9	82.8
weight	sd (kg)	3.5	9.7	5.2	8.6

31 adjudicated result lines, grouped by outcome. Open an outcome to see its values.

Serious adverse events (4 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	0 / 6	not stated; safety; R0015956:Results
A2	events	0 / 6	not stated; safety; R0015956:Results
A3	events	0 / 6	not stated; safety; R0015956:Results
A4	events	0 / 6	not stated; safety; R0015956:Results

Discontinuation due to adverse events (4 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	1 / 6	not stated; safety; R0015956:Results
A2	events	0 / 6	not stated; safety; R0015956:Abstract
A3	events	0 / 6	not stated; safety; R0015956:Abstract
A4	events	0 / 6	not stated; safety; R0015956:Abstract

Nausea (4 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	2 / 6	not stated; safety; R0015956:Table 2
A2	events	2 / 6	not stated; safety; R0015956:Table 2
A3	events	2 / 6	not stated; safety; R0015956:Table 2
A4	events	0 / 6	not stated; safety; R0015956:Table 2

Vomiting (4 lines; O27B)

Arm	Statistic	Events / N	Detail
A1	events	0 / 6	not stated; safety; R0015956:Table 2
A2	events	1 / 6	not stated; safety; R0015956:Table 2
A3	events	2 / 6	not stated; safety; R0015956:Table 2
A4	events	0 / 6	not stated; safety; R0015956:Table 2

Diarrhea (4 lines; O27C)

Arm	Statistic	Events / N	Detail
A1	events	1 / 6	not stated; safety; R0015956:Table 2
A2	events	2 / 6	not stated; safety; R0015956:Table 2
A3	events	1 / 6	not stated; safety; R0015956:Table 2
A4	events	1 / 6	not stated; safety; R0015956:Table 2

Constipation (4 lines; O27D)

Arm	Statistic	Events / N	Detail
A1	events	0 / 6	not stated; safety; R0015956:Table 2
A2	events	3 / 6	not stated; safety; R0015956:Table 2
A3	events	1 / 6	not stated; safety; R0015956:Table 2
A4	events	0 / 6	not stated; safety; R0015956:Table 2

Discontinuation due to gastrointestinal adverse events (3 lines; O27E)

Arm	Statistic	Events / N	Detail
A2	events	0 / 6	not stated; safety; R0015956:Abstract
A3	events	0 / 6	not stated; safety; R0015956:Abstract
A4	events	0 / 6	not stated; safety; R0015956:Abstract

Death by suicide (4 lines; O35B)

Arm	Statistic	Events / N	Detail
A1	events	0 / 6	not stated; safety; R0015956:Results
A2	events	0 / 6	not stated; safety; R0015956:Results
A3	events	0 / 6	not stated; safety; R0015956:Results
A4	events	0 / 6	not stated; safety; R0015956:Results