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Table 3 Safety and tolerability endpoints

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

  Placebo
(N = 60),
n (%)
PQ912
(N = 60),
n (%)
P
Safety
 Composite safety 0 (0.0) 6 (10.0) 0.027
 Discontinuation of subject due to SAE 0 (0.0) 6 (10.0) 0.027
 Discontinuation of subject due to AE with severity ≥ 3 according to CTCAE 0 (0.0) 6 (10.0) 0.027
 Discontinuation of subject due to extreme safety laboratory parameters 0 (0.0) 0 (0.0)
 Number of subjects with SAEs 5 (8.3)d 8 (13.3) 0.558
 Number of subjects with AEs with severity ≥ 3 according to CTCAE 3 (5.0)e 8 (13.3) 0.204
Tolerability
 Composite tolerability 6 (10.0) 27 (45.0) <.001
 Dose adjustment during treatment perioda 5 (8.3) 5 (8.3) 1.000
 Nonadherence to randomized treatmentb 2 (3.3) 26 (43.3) <.001
 Discontinued due to related AEc 0 (0.0) 19 (31.7) <.001
 Discontinued due to nonrelated AE 0 (0.0) 1 (1.7) 1.000
 Withdrawal of consent by subject 0 (0.0) 1 (1.7) 1.000
 Continued 2 (3.3) 5 (8.3) 0.439
  1. CTCAE common terminology criteria for adverse events, N number of subjects in population, n number of subjects, (S)AE (serious) adverse event
  2. aDose adjustment defined as reduction of dose from 800 mg bid to 400 mg bid, as allowed within the study protocol
  3. bNonadherence defined as: using < 75% of prescribed dose in 4 consecutive weeks including at least 1 week with less than 50%; or 3 or more consecutive days in total or 7 days of interrupted use during the full 12 weeks. Subjects could qualify for more than one criterion, but were listed once; reason ranked for relevance for tolerance
  4. cIncludes possibly related, probably related and related according to investigator
  5. dTreatment emergent in three subjects
  6. eTreatment emergent in one subject
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