Table 2 Treatment emergent adverse events summary and distribution by Medical Dictionary for Regulatory Activities (MedDRA) system organ classes (SOC) (with ≥ 3 subjects reporting in total)

TEAE summary

Placebo

(N = 60)

PQ912

(N = 60)

Subjects with any TEAE

40 (67)

45 (75)

Subjects who discontinued due to TEAE^a

0

20 (33)

 Mild

27 (45)

17 (28)

 Moderate

12 (20)

20 (33)

 Severe

1 (2)

8 (13)

Number of TEAEs

103

135

Subjects with serious TEAEs

3 (5)

8 (13)

Number of SAEs

5

13

Number of serious TEAEs

3

13

Deaths

0

0

MedDRA SOC—preferred term

 Blood and lymphatic system disorders

1

2

 Cardiac disorders

2

2

Gastrointestinal disorders

12

21

 Abdominal pain upper

3

1

 Constipation

0

3

 Diarrhea

1

5

 Dyspepsia

2

1

 Nausea

4

8

 Vomiting

1

2

General disorders and administration site conditions

6

5

Hepatobiliary disorders

0

3

Infections and infestations

17

17

Injury, poisoning and procedural complications

5

6

Investigations

5

8

Metabolism and nutrition disorders

2

7

Musculoskeletal and connective tissue disorders

8

5

Nervous system disorders

9

7

Psychiatric disorders

3

4

Renal and urinary disorders

1

3

Skin and subcutaneous tissue disorders

5

15

 Rash

2

4

 Rash generalized

0

1

 Rash maculopapular

1

1

 Urticaria

0

4

Vascular disorders

2

3