Table 3 Characteristics of adverse events during ganaxolone and placebo periods

 Mild

124

65.6

116

80.0

 Moderate

60

31.8

28

19.3

 Severe

5

2.7

1

0.7

 Not recovered

19

10.1

14

9.7

 Ongoing

5

2.7

5

3.5

 Recovered

163

86.2

125

86.2

 Unknown

2

1.1

1

0.7

 Continuous

46

27.5

32

24.1

 Intermittent

106

63.5

84

63.2

 Single

15

9.0

17

12.8

 Concomitant medication/therapy

13

6.9

17

11.7

 Dose decrease

13

6.9

4

2.8

 None

153

81.0

118

81.4

 Permanently discontinued

10

5.3

4

2.8

 Temporarily discontinued

0

0.0

2

1.4

 Definitely

2

1.1

0

0.0

 Probably

44

23.3

9

6.2

 Possibly

62

32.8

52

35.9

 Unlikely

33

17.5

32

22.1

 Not related

48

25.4

52

35.9

 No

189

100.0

145

100.0

 Upper respiratory infection

19

10.1

24

16.6

 Fatigue

28

14.8

16

11.0

 Drowsiness

23

12.2

6

4.1

 Diarrhea

10

5.3

10

6.9

 Agitation

4

2.1

7

4.8

 Vomiting

7

3.7

7

4.8

 Rash

9

4.8

6

4.1

 Decreased appetite

8

4.2

2

1.4

 Gastrointestinal issues

6

3.2

5

3.4

 Headache

5

2.6

5

3.4

 Ear infection

2

1.1

4

2.8

 Fever

1

0.5

4

2.8

 Sleep disturbance

3

1.6

4

2.8

 Abnormal vocalizations

5

2.6

3

2.1

 Aggression

4

2.1

3

2.1

 Skin infection

4

2.1

1

0.7

 Hyperactivity

3

1.6

3

2.1

 Irritability

2

1.1

3

2.1

 Rhinorrhea

3

2.1

 Anxiety

3

1.6

 Dizziness

3

1.6

1

0.7

 Hypersomnia

3

1.6

 Incoordination

3

1.6

1

0.7

 Itchiness

3

1.6

 Disruptive behavior

1

0.5

2

1.4

 Self-injurious behavior

2

1.1

2

1.4

 Falling

2

1.1

1

0.7

 Incontinence

2

1.1

1

0.7

 Skin abrasion

2

1.1

1

0.7

 Tics

2

1.1

 Abdominal pain upper

1

0.5

1

0.7

 Dental trauma

1

0.7

 Drooling

1

0.5

1

0.7

 Elevated transaminase

1

0.5

1

0.7

 Emotional lability

1

0.7

 Enlarged aorta

1

0.7

 Flushing

1

0.7

 Gynecomastia

1

0.7

 Hyperphagia

1

0.7

 Hypoglycemia

1

0.7

 Ketonuria

1

0.7

 Menstrual cramps

1

0.7

 Nausea

1

0.5

1

0.7

 Obsessive Compulsive Behavior

1

0.7

 Ruptured Ear Drum

1

0.7

 Scratch

1

0.7

 Seizures

1

0.5

1

0.7

 Staring Spells

1

0.5

1

0.7

 Thirst

1

0.7

 Wound

1

0.7

 Acne

1

0.5

 Decreased fluid intake

1

0.5

 Desquamation

1

0.5

 Dry mouth

1

0.5

 Excess cerumen

1

0.5

 Eye infection

1

0.5

 Increased appetite

1

0.5

 Musculoskeletal injury

1

0.5

 Nervousness

1

0.5

 Pallor

1

0.5

 Pharyngitis

1

0.5

 Rhinorrhea

1

0.5

 Thermal burn

1

0.5

 Dental operation

1

0.5