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Table 3 Summary of adverse events (AEs) by treatment group

From: NeuroEPO plus (NeuralCIM®) in mild-to-moderate Alzheimer’s clinical syndrome: the ATHENEA randomized clinical trial

Event

NeuroEPO plus

0.5 mg (n = 57)

NeuroEPO plus

1.0 mg (n = 56)

Placebo (n = 57)

Overview of AE — no. (%)

 Participants with any AE

5 (8.8)

3 (5.4)

3 (5.3)

 AE related to neuroEPO plus or placebo

1 (1.8)

0

0

 Serious AE

3 (5.3)

0

3 (5.3)

 Death (not related to treatment)

1 (1.8)

0

1(1.8)

 Participants with ≥ 1 serious AE

1 (1.8)

0

1(1.8)

AE that occurred in either group

 Bronchopneumonia

1(1.8)

0

1(1.8)

 Pulmonary embolism

1 (1.8)

0

0

 Numbness upper right member

1 (1.8)

0

0

 Bronchopneumonia

1 (1.8)

0

0

 Fall down

0

0

1(1.8)

 Headache

1 (1.8)

0

0

 Nasal congestion

1 (1.8)

0

0

 Constipation

1 (1.8)

0

0

 Dehydration

0

0

1(1.8)

 Pain due to fall down

0

0

1(1.8)

 Flu status

0

1 (1.8)

0

 Hypertension

0

1 (1.8)

0

 Hematoma due to fall down

0

0

1 (1.8)

 Urinary sepsis

0

1 (1.8)

0

 Irritability

0

0

1 (1.8)

 Palpitations

1 (1.8)

0

0

 Deep venous thrombosis

1 (1.8)

0

0

 Vomiting

1 (1.8)

1 (1.8)

1 (1.8)

 Diarrhea

0

1 (1.8)

0

  1. The analysis was performed in the safety population, which included participants who received at least one dose of neuroEPO or placebo
  2. AEs Adverse events, No. Number