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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)

From: Safety, tolerability and efficacy of the glutaminyl cyclase inhibitor PQ912 in Alzheimer’s disease: results of a randomized, double-blind, placebo-controlled phase 2a study

TEAE summary Placebo
(N = 60)
PQ912
(N = 60)
Subjects with any TEAE 40 (67) 45 (75)
Subjects who discontinued due to TEAEa 0 20 (33)
Subjects with TEAE by severity
 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
  1. Data presented as n (%) or n
  2. N number of subjects in population, n number of subjects, SAE serious adverse event, SOC system organ class, TEAE treatment emergent adverse event
  3. aThese subjects may still have completed end-of-study assessment
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