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Table 5 Summary of the observed adverse events in Treamid and placebo groups of SS population

From: Efficacy and safety of Treamid in the rehabilitation of patients after COVID-19 pneumonia: a phase 2, randomized, double-blind, placebo-controlled trial

Adverse events

Treamid group (n = 29)

Placebo group (n = 31)

p-valuea

AE, n (%) E

10

(34.5%)

21

9

(29.0%)

16

0.650 (c)

 Grade 1

10

(34.5%)

18

9

(29.0%)

16

0.650 (c)

 Grade 2

2

(6.9%)

3

0

(0.0%)

0

0.229 (f)

  Respiratory tract infection

1

(3.4%)

1

0

(0.0%)

0

0.483 (f)

  Conjunctivitis

1

(3.4%)

1

0

(0.0%)

0

0.483 (f)

  Ulcerative keratitis

1

(3.4%)

1

0

(0.0%)

0

0.483 (f)

 Leading to temporary treatment discontinuation

0

(0.0%)

0

1

(3.2%)

2

0.483 (f)

  Increased level of AST

0

(0.0%)

0

1

(3.2%)

1

0.483 (f)

  Increased level of CPK

0

(0.0%)

0

1

(3.2%)

1

0.483 (f)

Treatment-related AE, n (%) E

1

(3.4%)

2

0

(0.0%)

0

0.483 (f)

 Grade 1

1

(3.4%)

2

0

(0.0%)

0

0.483 (f)

  Increased level of CPK

1

(3.4%)

1

0

(0.0%)

0

0.483 (f)

  Gynecomastia

1

(3.4%)

1

0

(0.0%)

0

0.483 (f)

  1. AE adverse event, AST aspartate transaminase, CPK creatine phosphokinase
  2. aTest is put in brackets: c—Chi-squared test, f—Fisher’s exact test