Table 2 Adverse events occurring in 5% or more of participants in either group and serious adverse events

From: Effect of liraglutide 3.0 mg in individuals with obesity and moderate or severe obstructive sleep apnea: the SCALE Sleep Apnea randomized clinical trial

Event a

Liraglutide 3.0 mg (N=176)

Placebo (N=179)

 

N (%)

E

R

N (%)

E

R

Adverse events in 5% or more individuals

117 (66.5)

278

310.5

84 (46.9)

152

158.4

 Nausea

47 (26.7)

59

65.9

12 (6.7)

14

14.6

 Diarrhea

29 (16.5)

38

42.4

14 (7.8)

17

17.7

 Headache

25 (14.2)

26

29.0

20 (11.2)

23

24.0

 Constipation

21 (11.9)

26

29.0

6 (3.4)

7

7.3

 Upper respiratory tract infection

18 (10.2)

25

27.9

19 (10.6)

25

26.0

 Dyspepsia

15 (8.5)

20

22.3

2 (1.1)

2

2.1

 Nasopharyngitis

15 (8.5)

19

21.2

18 (10.1)

20

20.8

 Vomiting

13 (7.4)

16

17.9

5 (2.8)

5

5.2

 Gastroesophageal reflux disease

10 (5.7)

11

12.3

1 (0.6)

1

1.0

 Influenza

9 (5.1)

12

13.4

9 (5.0)

9

9.4

 Lipase increased

9 (5.1)

11

12.3

5 (2.8)

6

6.3

 Arthralgia

7 (4.0)

7

7.8

9 (5.0)

9

9.4

 Injection site hematoma

7 (4.0)

8

8.9

13 (7.3)

14

14.6

Serious adverse events

6 (3.4)

14

15.6

6 (3.4)

9

9.4

 Angina pectoris

2 (1.1)

3

3.4

0

0

0

 Anxiety

1 (0.6)

1

1.1

0

0

0

 Cholelithiasis

1 (0.6)

1

1.1

0

0

0

 Coronary revascularization

1 (0.6)

1

1.1

1 (0.6)

1

1.0

 Dehydration

1 (0.6)

1

1.1

0

0

0

 Depression suicidal

1 (0.6)

1

1.1

0

0

0

 Oropharyngeal swelling

1 (0.6)

1

1.1

0

0

0

 Pneumonia

1 (0.6)

1

1.1

0

0

0

 Procedural pain

1 (0.6)

1

1.1

0

0

0

 Sinus arrest

1 (0.6)

1

1.1

0

0

0

 Sleep apnea syndrome

1 (0.6)

1

1.1

0

0

0

 Spinal fracture

1 (0.6)

1

1.1

0

0

0

 Angina unstable

0

0

0

1 (0.6)

1

1.0

 Bone lesion

0

0

0

1 (0.6)

1

1.0

 Cholecystitis

0

0

0

1 (0.6)

1

1.0

 Gastroesophageal reflux disease

0

0

0

1 (0.6)

1

1.0

 Myocardial infarction

0

0

0

1 (0.6)

1

1.0

 Nightmare

0

0

0

1 (0.6)

1

1.0

 Obstruction gastric

0

0

0

1 (0.6)

1

1.0

 Prostate cancer

0

0

0

1 (0.6)

1

1.0

  1. Abbreviations: E, number of adverse events; N, number of participants; R, event rate per 100 exposure years; %, the proportion of participants reporting the adverse event.
  2. Data are based on the Safety Analysis Set.
  3. aAdverse events are presented by preferred term. Adverse events are treatment-emergent, defined as an event that has onset date on or after the first day of randomized treatment and no later than 14 days after the last day of randomized treatment. A participant could experience more than one adverse event.
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