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Table 2 Summary of safety (safety population)

From: Rezafungin versus caspofungin for patients with candidaemia or invasive candidiasis in the intensive care unit: pooled analyses of the ReSTORE and STRIVE randomised trials

n (%)a

Rezafungin 400/200 mg

(n = 46)

Caspofungin 70/50 mg

(n = 67)

 ≥ 1 TEAE

41 (89.1)

54 (80.6)

 ≥ 1 serious TEAE

28 (60.9)

38 (56.7)

 ≥ 1 study drug-related TEAE

4 (8.7)

11 (16.4)

 ≥ 1 study drug-related serious TEAE

1 (2.2)

4 (6.0)

 ≥ 1 TEAE leading to study/drug discontinuation

8 (17.4)

20 (29.9)

 ≥ 1 study drug-related TEAE leading to study/drug discontinuation

0 (0)

2 (3.0)

Most commonly occurring TEAEs (≥ 5% of either pooled treatment group)

[event severity (n): mild/moderate/severe]b,c

Blood and lymphatic system disorders

 Anaemia

7 (15.2) [2/4/1]

7 (10.4) [3/4/0]

Cardiac disorders

 Atrial fibrillation

3 (6.5) [1/2/0]

3 (4.5) [1/2/0]

 Bradycardia

1 (2.2) [0/1/0]

5 (7.5) [2/3/0]

Gastrointestinal disorders

 Diarrhoea

7 (15.2) [6/1/0]

7 (10.4) [4/3/0]

 Vomiting

7 (15.2) [4/4/0]

3 (4.5) [2/1/0]

 Abdominal pain

4 (8.7) [1/2/1]

4 (6.0) [3/0/1]

 Nausea

4 (8.7) [0/4/0]

4 (6.0) [1/3/0]

 Constipation

2 (4.3) [2/0/0]

4 (6.0) [3/1/0]

General disorders and administration site conditions

 Multiple organ dysfunction syndrome

3 (6.5) [0/0/3]

3 (4.5) [0/0/3]

 Peripheral oedema

3 (6.5) [3/0/0]

2 (3.0) [1/1/0]

 Pyrexia

2 (4.3) [1/1/0]

6 (9.0) [5/1/0]

Infections and infestations

 Septic shock

6 (13.0) [0/1/5]

7 (10.4) [0/0/7]

 Sepsis

5 (10.9) [3/2/1]

3 (4.5) [0/0/3]

 Pneumonia

3 (6.5) [0/0/3]

2 (3.0) [1/1/0]

 Abdominal abscess

1 (2.2) [0/1/0]

4 (6.0) [0/0/4]

Metabolism and nutrition disorders

 Hypokalaemia

4 (8.7) [3/1/0]

10 (14.9) [8/2/0]

 Fluid overload

4 (8.7) [0/3/1]

2 (3.0) [1/1/0]

 Hyperkalaemia

2 (4.3) [2/0/0]

5 (7.5) [2/2/1]

 Acidosis

1 (2.2) [1/1/0]

4 (6.0) [2/2/0]

Psychiatric disorders

 Insomnia

4 (8.7) [3/1/0]

2 (3.0) [1/1/0]

Renal and urinary disorders

 Acute kidney injury

1 (2.2) [1/1/0]

4 (6.0) [1/1/2]

Respiratory, thoracic, and mediastinal disorders

 Dyspnoea

0 (0) [0/0/0]

4 (6.0) [1/2/1]

 Pleural effusion

0 (0) [0/0/0]

4 (6.0) [1/3/0]

 Pneumothorax

0 (0) [0/0/0]

4 (6.0) [1/3/0]

 Respiratory failure

0 (0) [0/0/0]

4 (6.0) [0/0/4]

Skin and subcutaneous tissue disorders

 Decubitus ulcer

3 (6.5) [2/1/0]

5 (7.5) [2/2/1]

Vascular disorders

 Hypotension

3 (6.5) [2/1/0]

6 (9.0) [3/3/1]

 Hypertension

3 (6.5) [2/1/0]

3 (4.5) [2/0/1]

 Deep vein thrombosis

1 (2.2) [1/0/0]

4 (6.0) [1/3/0]

  1. TEAE treatment-emergent adverse event
  2. aPatients with multiple events in the same system organ class or preferred term are counted only once (highest severity of TEAE reported)
  3. bFor the number of events with mild/moderate/severe severity, it was possible for patients to experience an adverse event at ≥ 1 severity; therefore, the number of events could be more than the number of patients with events
  4. cAs TEAEs were graded differently in STRIVE and ReSTORE, here they are listed by severity
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Critical Care

ISSN: 1364-8535