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Table 3 Incidences of adverse drug reactions in patients with chemotherapy-induced peripheral neuropathy in the MiroCIP interventional study (safety analysis set)

From: Efficacy and safety of mirogabalin for chemotherapy-induced peripheral neuropathy: a prospective single-arm trial (MiroCIP study)

ADRa

n (%)

Overall

16 (30.8)

Occurring in ≥ 1 patient

 Somnolence

7 (13.5)

 Dizziness

5 (9.6)

 Oedema peripheral

2 (3.8)

 Abdominal discomfort

1 (1.9)

 Altered state of consciousness

1 (1.9)

 Fall

1 (1.9)

 Hepatic function abnormal

1 (1.9)

 Liver disorder

1 (1.9)

 Loss of consciousness

1 (1.9)

 Thirst

1 (1.9)

Serious ADRs

0 (0.0)

Discontinuation due to ADRs

6 (11.5)b

Death

0 (0.0)

  1. ADR, Adverse drug reaction
  2. aCoded using the Japanese version of the Medical Dictionary for Regulatory Activities, version 25.0
  3. bA total of 7 ADRs in 6 patients