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Table 4 Summary of PRAEs, TEAEs, and drug-related TEAEs (safety analysis set)

From: Capsaicin 8% patch repeat treatment plus standard of care (SOC) versus SOC alone in painful diabetic peripheral neuropathy: a randomised, 52-week, open-label, safety study

Event, n (%)

Capsaicin 8% patch (30 min) + SOC

(n = 156)

Capsaicin 8% patch (60 min) + SOC

(n = 157)

SOC (n = 155)

PRAEs

105 (67.3)

109 (69.4)

75 (48.4)

 Mild PRAEs

83 (53.2)

89 (56.7)

55 (35.5)

 Moderate PRAEs

50 (32.1)

54 (34.4)

34 (21.9)

 Severe PRAEs

19 (12.2)

12 (7.6)

10 (6.5)

PRAEs identified as general disorders or administration site conditions

54 (34.6)

53 (33.8)

10 (6.5)

 Application site pain

44 (28.2)

46 (29.3)

0 (0)

  Mild

23 (14.7)

28 (17.8)

0 (0)

  Moderate

19 (12.2)

16 (10.2)

0 (0)

  Severe

2 (1.3)

2 (1.3)

0 (0)

 Application site erythema

12 (7.7)

14 (8.9)

0 (0)

  Mild

12 (7.7)

13 (8.3)

0 (0)

  Moderate

0 (0)

1 (0.6)

0 (0)

  Severe

0 (0)

0 (0)

0 (0)

PRAEs leading to permanent discontinuation

7 (4.5)

8 (5.1)

3 (1.9)

TEAEs

104 (66.7)

106 (67.5)

N/A

 Application site reactions

60 (38.5)

69 (43.9)

 

TEAEs most commonly reported (>5% of each group)

  

N/A

 Application site pain

44 (28.2)

46 (29.3)

 

 Burning sensation

14 (9.0)

15 (9.6)

 

 Application site erythema

12 (7.7)

14 (8.9)

 

 Pain in extremity

6 (3.8)

13 (8.3)

 

TEAEs leading to permanent discontinuation

7 (4.5)

8 (5.1)

N/A

Drug-relateda TEAEs

62 (39.7)

71 (45.2)

N/A

Drug-relateda TEAEs leading to permanent discontinuation

0 (0)

4 (2.5)

N/A

 Muscle spasmsb

0 (0)

1 (0.6)

 

 Rectal adenocarcinomac

0 (0)

1 (0.6)

 

 Neuralgiad

0 (0)

1 (0.6)

 

 Plantar psoriasise

0 (0)

1 (0.6)

 

Severe TEAEs

19 (12.2)

12 (7.6)

N/A

Drug-relateda severe TEAEs

4 (2.6)

3 (1.9)

N/A

 Application site pain

2 (1.3)

2 (1.3)

 

 Rectal adenocarcinomac

0 (0)

1 (0.6)

 

 Burning sensation

1 (0.6)

0 (0)

 

 Hypoaesthesia

1 (0.6)

0 (0)

 

Serious TEAEs

20 (12.8)

13 (8.3)

N/A

Drug-relateda serious TEAEs

0 (0)

2 (1.3)

N/A

 Angina pectorisf

0 (0)

1 (0.6)

 

 Accelerated hypertensiong

0 (0)

1 (0.6)

 

 Rectal adenocarcinomac

0 (0)

1 (0.6)

 

Deaths

1 (0.6)

1 (0.6)

2 (1.3)

  1. N/A not applicable in SOC alone group, PRAE post-randomisation adverse event, SOC standard of care, TEAE treatment-emergent adverse event
  2. aPossible or probable, as assessed by the investigator, or records where relationship is missing
  3. bMuscle spasms in both legs of one patient were considered unlikely to have been caused by the capsaicin 8% patch, but a causal association could not be excluded. The same patient also previously reported cramps in the toes
  4. cRectal adenocarcinoma was considered unlikely to have started during the study and reach grade T3 within 129 days; however, a causal association with the capsaicin 8% patch could not be excluded
  5. dOne case of neuralgia was considered probably related to the study drug in view of the close temporal association with dosing and the known ability of the capsaicin 8% patch to cause application site pain
  6. eAlthough the capsaicin 8% patch could not be excluded as a cause of one event of plantar psoriasis, the mechanism by which it could cause an autoimmune condition such as psoriasis is unclear and a causal association was considered unlikely
  7. f, gAngina pectoris and accelerated hypertension were likely related to the patient’s co-existing ischemic heart disease and hypertension but a causal association with the capsaicin 8% patch could not be excluded
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BMC Neurology

ISSN: 1471-2377

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