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Table 2 Overall summary of TEAEs (pooled safety population)

From: Lefamulin efficacy and safety in a pooled phase 3 clinical trial population with community-acquired bacterial pneumonia and common clinical comorbidities

Patients, n (%)

Lefamulin

(n = 641)

Moxifloxacin

(n = 641)

All TEAEs*

224 (34.9)

195 (30.4)

 Mild

119 (18.6)

117 (18.3)

 Moderate

78 (12.2)

55 (8.6)

 Severe

27 (4.2)

23 (3.6)

Related TEAEs†

99 (15.4)

68 (10.6)

Serious TEAEs

36 (5.6)

31 (4.8)

TEAEs leading to study drug discontinuation‡

20 (3.1)

21 (3.3)

TEAEs leading to death by study day 28§

8 (1.2)

7 (1.1)

TEAEs leading to death (over entire study duration)||

11 (1.7)

8 (1.2)

TEAEs by preferred term in ≥ 2% of patients

  

 Diarrhea

47 (7.3)

25 (3.9)

 Nausea

27 (4.2)

13 (2.0)

 Vomiting

15 (2.3)

4 (0.6)

  1. AE adverse event, COPD chronic obstructive pulmonary disease, MedDRA Medical Dictionary for Regulatory Activities, PORT Pneumonia Outcomes Research Team, TEAE treatment-emergent AE
  2. *AEs with unknown start date, or partial date such that it could not be determined if they started on or after first study drug administration, were categorized as TEAEs; AEs were classified using the MedDRA version 20.0
  3. †Related TEAEs were defined as TEAEs that were considered “definitely,” “probably,” or “possibly” related to study drug by the investigator. If the relationship for a TEAE was missing, it was considered “related.” Patients with multiple events in each category were counted only once in that category
  4. ‡A patient could have > 1 TEAE leading to study drug discontinuation
  5. §Assessed in the intent-to-treat population (lefamulin, n = 646; moxifloxacin, n = 643)
  6. ||Three patients in the lefamulin group had a TEAE leading to death after study day 28: 1 patient (aged 87 years; PORT risk class III; liver enzyme elevation and moderate renal impairment [creatinine clearance 30 to < 60 mL/min] at baseline; history of hypertension and COPD) died on study day 32 from sepsis (first reported on study day 31); 1 patient (aged 80 years; PORT risk class III; baseline moderate renal impairment; history of hypertension and COPD) died on study day 57 from endocarditis (first reported on study day 24); and 1 patient (aged 70 years; PORT risk class II; baseline moderate renal impairment; history of hypertension and COPD) died on study day 271 from acute myeloid leukemia (first reported on study day 269). One patient in the moxifloxacin group (aged 26 years; PORT risk class IV) had a TEAE leading to death on study day 48 due to testicular seminoma (first reported on study day 21)
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BMC Pulmonary Medicine

ISSN: 1471-2466

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