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Table 3 TEAEs by System Organ Class and Preferred Terma

From: Efficacy and safety of Bacillus clausii (O/C, N/R, SIN, T) probiotic combined with oral rehydration therapy (ORT) and zinc in acute diarrhea in children: a randomized, double-blind, placebo-controlled study in India

 

B. clausii

(n = 227)

Placebo

(n = 227)

Patients with any TEAE

22 (9.7)

28 (12.3)

Patients with any treatment-emergent serious AE

0

0

Patients with any treatment-emergent AESI

0

0

Patients with any TEAE leading to death

0

0

Patients with any TEAE leading to definitive

treatment discontinuation

2 (0.9)

3 (1.3)

Infections and infestations

6 (2.6)

7 (3.1)

 Nasopharyngitis

5 (2.2)

3 (1.3)

 Upper respiratory tract infection

1 (0.4)

3 (1.3)

 Dysentery

0

1 (0.4)

Blood and lymphatic system disorders

1 (0.4)

0

 Anemia

1 (0.4)

0

Metabolism and nutrition disorders

3 (1.3)

3 (1.3)

 Dehydration

2 (0.9)

2 (0.9)

 Hypokalemia

2 (0.9)

0

 Lactose intolerance

0

1 (0.4)

Eye disorders

0

1 (0.4)

 Periorbital swelling

0

1. (0.4)

Respiratory, thoracic and mediastinal disorders

1 (0.4)

4 (1.8)

 Rhinorrhea

1 (0.4)

2 (0.9)

 Cough

0

2 (0.9)

Gastrointestinal disorders

6 (2.6)

8 (3.5)

 Vomiting

6 (2.6)

6 (2.6)

 Upper abdominal pain

0

1 (0.4)

 Diarrhea

0

1 (0.4)

Skin and subcutaneous tissue disorders

2 (0.9)

0

 Rash

1 (0.4)

0

 Erythematous rash

1 (0.4)

0

General disorders and administration site conditions

5 (2.2)

6 (2.6)

 Pyrexia

5 (2.2)

6 (2.6)

  1. aMedDRA dictionary 23.0
  2. Data expressed as n (%)
  3. AESI, adverse event of special interest; TEAE, treatment-emergent adverse event