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NCT04467697 · OUTCOME

Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment.

Ambulatory Blood Pressure Monitoring (ABPM) Extension Study of Oral Testosterone Undecanoate in Hypogonadal Men · Source last updated 2024-06-28

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: MEAN
Unit: bpm
Interval / dispersion: Standard Deviation
Time frame: 120 and 180 days

What was measured

Observed and change from baseline in Ambulatory half hourly heart rate as measured by ABPM after 120 Days (+/-3) and after 180 Days (+/-3) of SOV2012-F1 treatment.

Analysis population: Extension Treated Set

Groups in this outcome

SOV2012-F1-treated - Heart Rate (Bpm), Baseline

Baseline Ambulatory Blood Pressure Monitoring (ABPM) heart rate.

SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E

Observed Ambulatory Blood Pressure Monitoring heart rate after 120 days of treatment with SOV2012-F1.

SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E

Change from Baseline for Ambulatory Blood Pressure Monitoring heart rate after 120 days of treatment with SOV2012-F1.

SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E

Observed Ambulatory Blood Pressure Monitoring heart rate after 180 days of treatment with SOV2012-F1.

SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E

Change from Baseline for Ambulatory Blood Pressure Monitoring heart rate after 180 days of treatment with SOV2012-F1.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	155
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	155
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	155
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	155
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	155

Reported measurements

0 hours

Analysis denominator · Participants

Group	Source count
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	153
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	136
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	136
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	125
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	125

Values in bpm · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	72.6	10.22	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	74.5	10.15	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	2.3	9.72	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	74.5	11.63	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	3.0	10.17	Not reported	Not reported	Not reported

0.5 hours

Analysis denominator · Participants

Group	Source count
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	142
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	120
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	111
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	115
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	109

Values in bpm · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	76.0	12.94	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	77.6	12.70	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	0.5	11.06	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	78.1	14.86	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	3.4	14.24	Not reported	Not reported	Not reported

1 hour

Analysis denominator · Participants

Group	Source count
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	144
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	125
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	118
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	112
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	106

Values in bpm · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	77.7	15.77	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	80.4	13.03	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	2.4	16.11	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	81.1	16.17	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	4.5	18.28	Not reported	Not reported	Not reported

1.5 hours

Analysis denominator · Participants

Group	Source count
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	143
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	128
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	120
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	116
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	109

Values in bpm · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	79.9	12.93	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	80.8	16.36	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	1.4	16.77	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	83.1	14.84	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	3.6	15.81	Not reported	Not reported	Not reported

2 hours

Analysis denominator · Participants

Group	Source count
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	148
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	131
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	126
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	119
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	117

Values in bpm · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	80.7	15.79	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	80.8	13.53	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	0.8	16.59	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	82.9	15.78	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	3.6	16.50	Not reported	Not reported	Not reported

2.5 hours

Analysis denominator · Participants

Group	Source count
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	144
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	127
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	121
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	123
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	118

Values in bpm · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	79.4	14.63	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	80.3	14.60	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	0.7	15.94	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	82.8	15.84	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	4.4	15.38	Not reported	Not reported	Not reported

3 hours

Analysis denominator · Participants

Group	Source count
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	152
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	127
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	126
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	121
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	121

Values in bpm · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	79.0	13.08	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	79.5	13.15	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	0.2	14.08	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	80.3	15.85	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	2.7	14.96	Not reported	Not reported	Not reported

3.5 hours

Analysis denominator · Participants

Group	Source count
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	147
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	129
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	125
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	124
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	119

Values in bpm · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	79.3	15.29	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	80.1	13.81	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	0.4	18.50	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	79.9	16.20	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	2.3	18.42	Not reported	Not reported	Not reported

4 hours

Analysis denominator · Participants

Group	Source count
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	144
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	133
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	125
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	116
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	109

Values in bpm · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	78.4	14.73	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	79.7	14.59	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	1.1	15.37	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	80.1	16.23	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	2.8	18.74	Not reported	Not reported	Not reported

4.5 hours

Analysis denominator · Participants

Group	Source count
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	145
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	131
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	124
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	121
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	117

Values in bpm · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	79.1	15.18	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	79.2	13.65	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	0.4	16.29	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	79.9	15.05	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	3.0	16.75	Not reported	Not reported	Not reported

5 hours

Analysis denominator · Participants

Group	Source count
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	149
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	129
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	125
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	119
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	116

Values in bpm · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	79.0	15.42	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	80.5	14.79	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	1.2	16.09	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	79.7	15.39	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	2.9	14.93	Not reported	Not reported	Not reported

5.5 hours

Analysis denominator · Participants

Group	Source count
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	150
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	129
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	128
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	123
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	121

Values in bpm · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	78.5	14.56	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	80.6	13.19	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	1.9	15.36	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	81.0	16.05	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	4.0	16.48	Not reported	Not reported	Not reported

6 hours

Analysis denominator · Participants

Group	Source count
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	149
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	130
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	128
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	123
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	120

Values in bpm · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	79.3	14.41	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	80.5	13.26	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	1.2	15.46	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	80.4	14.02	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	2.9	15.49	Not reported	Not reported	Not reported

6.5 hours

Analysis denominator · Participants

Group	Source count
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	146
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	132
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	126
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	118
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	112

Values in bpm · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	79.2	15.03	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	80.1	14.40	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	1.5	14.90	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	80.4	13.94	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	3.2	15.91	Not reported	Not reported	Not reported

7 hours

Analysis denominator · Participants

Group	Source count
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	149
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	134
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	131
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	122
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	120

Values in bpm · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	80.6	15.04	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	80.9	13.85	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	0.8	14.83	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	79.8	13.27	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	0.6	15.44	Not reported	Not reported	Not reported

7.5 hours

Analysis denominator · Participants

Group	Source count
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	148
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	130
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	127
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	122
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	119

Values in bpm · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	80.0	14.51	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	79.5	13.66	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	-0.3	15.20	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	81.1	14.52	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	2.4	14.98	Not reported	Not reported	Not reported

8 hours

Analysis denominator · Participants

Group	Source count
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	150
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	132
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	131
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	123
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	121

Values in bpm · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	81.5	14.63	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	80.8	14.18	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	-0.9	15.86	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	80.8	14.34	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	0.5	15.15	Not reported	Not reported	Not reported

8.5 hours

Analysis denominator · Participants

Group	Source count
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	147
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	127
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	123
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	122
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	118

Values in bpm · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	80.0	14.09	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	79.9	14.41	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	-0.1	13.89	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	79.9	13.34	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	0.6	14.18	Not reported	Not reported	Not reported

9 hours

Analysis denominator · Participants

Group	Source count
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	148
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	127
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	123
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	117
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	114

Values in bpm · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	80.1	13.86	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	80.9	14.06	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	0.2	14.70	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	82.2	13.93	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	2.5	15.45	Not reported	Not reported	Not reported

9.5 hours

Analysis denominator · Participants

Group	Source count
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	149
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	128
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	126
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	118
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	118

Values in bpm · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	79.9	14.21	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	80.1	16.09	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	-0.1	14.18	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	81.8	13.70	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	2.1	16.58	Not reported	Not reported	Not reported

10 hours

Analysis denominator · Participants

Group	Source count
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	148
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	129
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	126
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	118
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	114

Values in bpm · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	81.8	16.28	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	80.6	15.75	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	-1.0	15.28	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	82.1	14.95	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	1.1	16.53	Not reported	Not reported	Not reported

10.5 hours

Analysis denominator · Participants

Group	Source count
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	147
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	129
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	124
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	120
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	115

Values in bpm · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	80.4	14.75	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	78.4	13.73	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	-2.2	13.59	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	80.7	13.82	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	1.2	15.30	Not reported	Not reported	Not reported

11 hours

Analysis denominator · Participants

Group	Source count
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	146
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	132
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	127
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	121
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	116

Values in bpm · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	79.9	14.07	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	80.5	15.79	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	0.3	14.52	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	80.8	13.14	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	2.0	13.84	Not reported	Not reported	Not reported

11.5 hours

Analysis denominator · Participants

Group	Source count
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	149
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	127
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	124
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	121
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	119

Values in bpm · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	79.8	14.31	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	79.4	14.58	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	-1.0	16.26	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	80.2	15.05	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	0.9	14.64	Not reported	Not reported	Not reported

12 hours

Analysis denominator · Participants

Group	Source count
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	152
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	133
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	132
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	122
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	122

Values in bpm · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	79.5	13.80	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	79.3	15.02	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	-0.5	15.77	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	79.8	14.57	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	1.2	13.92	Not reported	Not reported	Not reported

12.5 hours

Analysis denominator · Participants

Group	Source count
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	152
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	132
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	131
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	121
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	120

Values in bpm · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	78.8	13.66	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	79.1	15.12	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	0.7	15.81	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	78.9	14.33	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	0.8	13.62	Not reported	Not reported	Not reported

13 hours

Analysis denominator · Participants

Group	Source count
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	151
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	132
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	130
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	120
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	119

Values in bpm · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	76.4	12.04	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	77.6	13.23	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	1.7	13.59	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	77.8	14.49	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	2.3	14.37	Not reported	Not reported	Not reported

13.5 hours

Analysis denominator · Participants

Group	Source count
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	147
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	133
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	127
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	124
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	120

Values in bpm · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	75.8	12.05	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	77.6	13.90	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	2.3	14.01	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	78.1	15.15	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	3.7	14.77	Not reported	Not reported	Not reported

14 hours

Analysis denominator · Participants

Group	Source count
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	152
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	134
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	134
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	122
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	122

Values in bpm · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	75.6	12.47	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	75.5	13.44	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	0.1	13.93	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	75.9	13.63	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	1.0	13.19	Not reported	Not reported	Not reported

14.5 hours

Analysis denominator · Participants

Group	Source count
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	152
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	134
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	133
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	121
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	120

Values in bpm · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	73.3	12.74	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	75.5	12.80	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	2.0	13.70	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	75.1	13.76	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	2.3	14.03	Not reported	Not reported	Not reported

15 hours

Analysis denominator · Participants

Group	Source count
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	146
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	133
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	126
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	122
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	116

Values in bpm · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	72.5	11.47	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	74.5	12.37	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	2.0	13.02	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	74.3	13.49	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	2.3	11.29	Not reported	Not reported	Not reported

15.5 hours

Analysis denominator · Participants

Group	Source count
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	151
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	133
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	131
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	122
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	120

Values in bpm · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	72.0	12.06	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	73.3	12.41	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	1.1	12.61	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	72.9	12.71	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	1.1	12.61	Not reported	Not reported	Not reported

16 hours

Analysis denominator · Participants

Group	Source count
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	151
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	135
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	133
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	120
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	118

Values in bpm · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	70.8	12.21	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	71.9	12.01	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	1.0	11.48	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	72.6	12.32	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	1.7	12.40	Not reported	Not reported	Not reported

16.5 hours

Analysis denominator · Participants

Group	Source count
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	151
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	134
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	132
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	123
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	121

Values in bpm · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	69.5	10.97	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	71.0	11.59	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	1.8	12.13	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	72.0	13.19	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	2.5	12.75	Not reported	Not reported	Not reported

17 hours

Analysis denominator · Participants

Group	Source count
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	152
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	134
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	133
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	119
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	118

Values in bpm · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	69.7	12.03	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	70.5	11.83	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	0.8	11.60	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	70.2	13.07	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	0.8	12.09	Not reported	Not reported	Not reported

17.5 hours

Analysis denominator · Participants

Group	Source count
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	153
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	133
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	133
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	121
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	121

Values in bpm · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	69.5	10.94	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	69.9	11.53	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	0.5	12.57	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	70.3	13.13	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	0.4	13.22	Not reported	Not reported	Not reported

18 hours

Analysis denominator · Participants

Group	Source count
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	153
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	133
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	133
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	123
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	123

Values in bpm · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	68.2	11.40	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	68.7	10.61	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	0.5	11.33	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	69.4	12.94	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	1.4	12.65	Not reported	Not reported	Not reported

18.5 hours

Analysis denominator · Participants

Group	Source count
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	149
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	131
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	127
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	123
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	119

Values in bpm · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	68.4	11.24	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	68.4	11.23	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	0.2	10.66	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	69.5	13.10	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	1.4	13.11	Not reported	Not reported	Not reported

19 hours

Analysis denominator · Participants

Group	Source count
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	151
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	135
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	133
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	122
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	120

Values in bpm · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	67.4	10.88	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	67.6	10.68	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	0.4	10.56	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	69.2	13.04	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	2.1	11.70	Not reported	Not reported	Not reported

19.5 hours

Analysis denominator · Participants

Group	Source count
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	149
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	133
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	129
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	123
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	120

Values in bpm · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	67.1	11.10	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	67.4	11.15	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	0.9	11.08	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	69.8	12.70	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	2.7	12.47	Not reported	Not reported	Not reported

20 hours

Analysis denominator · Participants

Group	Source count
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	149
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	135
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	134
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	121
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	120

Values in bpm · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	68.5	11.67	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	66.8	10.85	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	-1.2	11.74	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	67.7	12.50	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	-0.4	13.55	Not reported	Not reported	Not reported

20.5 hours

Analysis denominator · Participants

Group	Source count
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	148
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	134
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	130
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	120
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	117

Values in bpm · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	68.5	12.28	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	67.3	11.70	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	-0.8	13.57	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	68.4	12.36	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	0.0	12.43	Not reported	Not reported	Not reported

21 hours

Analysis denominator · Participants

Group	Source count
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	150
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	128
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	126
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	122
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	120

Values in bpm · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	69.0	11.22	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	68.1	12.46	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	-0.6	13.25	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	68.8	12.70	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	-0.2	12.68	Not reported	Not reported	Not reported

21.5 hours

Analysis denominator · Participants

Group	Source count
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	150
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	131
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	129
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	155
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	122

Values in bpm · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	69.9	13.57	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	68.2	11.52	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	-1.4	14.26	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	71.6	13.75	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	1.4	13.83	Not reported	Not reported	Not reported

22 hours

Analysis denominator · Participants

Group	Source count
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	143
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	124
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	118
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	117
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	110

Values in bpm · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	71.3	15.14	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	70.4	13.80	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	-0.6	16.58	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	73.0	14.46	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	3.1	14.46	Not reported	Not reported	Not reported

22.5 hours

Analysis denominator · Participants

Group	Source count
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	139
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	120
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	109
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	109
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	100

Values in bpm · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	73.6	12.08	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	75.0	15.82	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	2.2	16.44	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	75.3	16.29	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	3.1	14.80	Not reported	Not reported	Not reported

23 hours

Analysis denominator · Participants

Group	Source count
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	133
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	116
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	99
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	110
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	96

Values in bpm · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	75.9	16.45	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	74.5	13.07	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	1.2	12.72	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	75.9	13.58	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	1.8	12.75	Not reported	Not reported	Not reported

23.5 hours

Analysis denominator · Participants

Group	Source count
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	130
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	122
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	103
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	111
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	97

Values in bpm · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
SOV2012-F1-treated - Heart Rate (Bpm), Baseline	74.2	11.67	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E	77.8	13.99	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E	3.2	14.69	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E	79.6	17.40	Not reported	Not reported	Not reported
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E	3.7	12.82	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
10.22
value
72.6
group Id
OG001
spread
10.15
value
74.5
group Id
OG002
spread
9.72
value
2.3
group Id
OG003
spread
11.63
value
74.5
group Id
OG004
spread
10.17
value
3.0
denoms
counts
group Id
OG000
value
153
group Id
OG001
value
136
group Id
OG002
value
136
group Id
OG003
value
125
group Id
OG004
value
125
units
Participants
title
0 hours
categories
measurements
group Id
OG000
spread
12.94
value
76.0
group Id
OG001
spread
12.70
value
77.6
group Id
OG002
spread
11.06
value
0.5
group Id
OG003
spread
14.86
value
78.1
group Id
OG004
spread
14.24
value
3.4
denoms
counts
group Id
OG000
value
142
group Id
OG001
value
120
group Id
OG002
value
111
group Id
OG003
value
115
group Id
OG004
value
109
units
Participants
title
0.5 hours
categories
measurements
group Id
OG000
spread
15.77
value
77.7
group Id
OG001
spread
13.03
value
80.4
group Id
OG002
spread
16.11
value
2.4
group Id
OG003
spread
16.17
value
81.1
group Id
OG004
spread
18.28
value
4.5
denoms
counts
group Id
OG000
value
144
group Id
OG001
value
125
group Id
OG002
value
118
group Id
OG003
value
112
group Id
OG004
value
106
units
Participants
title
1 hour
categories
measurements
group Id
OG000
spread
12.93
value
79.9
group Id
OG001
spread
16.36
value
80.8
group Id
OG002
spread
16.77
value
1.4
group Id
OG003
spread
14.84
value
83.1
group Id
OG004
spread
15.81
value
3.6
denoms
counts
group Id
OG000
value
143
group Id
OG001
value
128
group Id
OG002
value
120
group Id
OG003
value
116
group Id
OG004
value
109
units
Participants
title
1.5 hours
categories
measurements
group Id
OG000
spread
15.79
value
80.7
group Id
OG001
spread
13.53
value
80.8
group Id
OG002
spread
16.59
value
0.8
group Id
OG003
spread
15.78
value
82.9
group Id
OG004
spread
16.50
value
3.6
denoms
counts
group Id
OG000
value
148
group Id
OG001
value
131
group Id
OG002
value
126
group Id
OG003
value
119
group Id
OG004
value
117
units
Participants
title
2 hours
categories
measurements
group Id
OG000
spread
14.63
value
79.4
group Id
OG001
spread
14.60
value
80.3
group Id
OG002
spread
15.94
value
0.7
group Id
OG003
spread
15.84
value
82.8
group Id
OG004
spread
15.38
value
4.4
denoms
counts
group Id
OG000
value
144
group Id
OG001
value
127
group Id
OG002
value
121
group Id
OG003
value
123
group Id
OG004
value
118
units
Participants
title
2.5 hours
categories
measurements
group Id
OG000
spread
13.08
value
79.0
group Id
OG001
spread
13.15
value
79.5
group Id
OG002
spread
14.08
value
0.2
group Id
OG003
spread
15.85
value
80.3
group Id
OG004
spread
14.96
value
2.7
denoms
counts
group Id
OG000
value
152
group Id
OG001
value
127
group Id
OG002
value
126
group Id
OG003
value
121
group Id
OG004
value
121
units
Participants
title
3 hours
categories
measurements
group Id
OG000
spread
15.29
value
79.3
group Id
OG001
spread
13.81
value
80.1
group Id
OG002
spread
18.50
value
0.4
group Id
OG003
spread
16.20
value
79.9
group Id
OG004
spread
18.42
value
2.3
denoms
counts
group Id
OG000
value
147
group Id
OG001
value
129
group Id
OG002
value
125
group Id
OG003
value
124
group Id
OG004
value
119
units
Participants
title
3.5 hours
categories
measurements
group Id
OG000
spread
14.73
value
78.4
group Id
OG001
spread
14.59
value
79.7
group Id
OG002
spread
15.37
value
1.1
group Id
OG003
spread
16.23
value
80.1
group Id
OG004
spread
18.74
value
2.8
denoms
counts
group Id
OG000
value
144
group Id
OG001
value
133
group Id
OG002
value
125
group Id
OG003
value
116
group Id
OG004
value
109
units
Participants
title
4 hours
categories
measurements
group Id
OG000
spread
15.18
value
79.1
group Id
OG001
spread
13.65
value
79.2
group Id
OG002
spread
16.29
value
0.4
group Id
OG003
spread
15.05
value
79.9
group Id
OG004
spread
16.75
value
3.0
denoms
counts
group Id
OG000
value
145
group Id
OG001
value
131
group Id
OG002
value
124
group Id
OG003
value
121
group Id
OG004
value
117
units
Participants
title
4.5 hours
categories
measurements
group Id
OG000
spread
15.42
value
79.0
group Id
OG001
spread
14.79
value
80.5
group Id
OG002
spread
16.09
value
1.2
group Id
OG003
spread
15.39
value
79.7
group Id
OG004
spread
14.93
value
2.9
denoms
counts
group Id
OG000
value
149
group Id
OG001
value
129
group Id
OG002
value
125
group Id
OG003
value
119
group Id
OG004
value
116
units
Participants
title
5 hours
categories
measurements
group Id
OG000
spread
14.56
value
78.5
group Id
OG001
spread
13.19
value
80.6
group Id
OG002
spread
15.36
value
1.9
group Id
OG003
spread
16.05
value
81.0
group Id
OG004
spread
16.48
value
4.0
denoms
counts
group Id
OG000
value
150
group Id
OG001
value
129
group Id
OG002
value
128
group Id
OG003
value
123
group Id
OG004
value
121
units
Participants
title
5.5 hours

denoms

counts
group Id
OG000
value
155
group Id
OG001
value
155
group Id
OG002
value
155
group Id
OG003
value
155
group Id
OG004
value
155
units
Participants

description

Observed and change from baseline in Ambulatory half hourly heart rate as measured by ABPM after 120 Days (+/-3) and after 180 Days (+/-3) of SOV2012-F1 treatment.

dispersion Type

Standard Deviation

groups

description
Baseline Ambulatory Blood Pressure Monitoring (ABPM) heart rate.
id
OG000
title
SOV2012-F1-treated - Heart Rate (Bpm), Baseline
description
Observed Ambulatory Blood Pressure Monitoring heart rate after 120 days of treatment with SOV2012-F1.
id
OG001
title
SOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120E
description
Change from Baseline for Ambulatory Blood Pressure Monitoring heart rate after 120 days of treatment with SOV2012-F1.
id
OG002
title
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120E
description
Observed Ambulatory Blood Pressure Monitoring heart rate after 180 days of treatment with SOV2012-F1.
id
OG003
title
SOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180E
description
Change from Baseline for Ambulatory Blood Pressure Monitoring heart rate after 180 days of treatment with SOV2012-F1.
id
OG004
title
SOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E

param Type

MEAN

population Description

Extension Treated Set

reporting Status

POSTED

time Frame

120 and 180 days

title

Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment.

type

SECONDARY

unit Of Measure

bpm

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice