Table 2 Adverse events

From: NR-SAFE: a randomized, double-blind safety trial of high dose nicotinamide riboside in Parkinson’s disease

Adverse event

NR (n = 10)

Placebo (n = 10)

Causal relationship to study drug (n)

pj

CTCAEi grading Grade 1–5 (n)

Headache

3

0

Possible (1) Unlikely (2)

0.21

Grade 1 (3)

Dyspepsia

2

1

Possible (3)

1

Grade 1 (3)

Nausea

2

0

Possible (2)

0.47

Grade 1 (2)

Dizziness

1

1

Possible (2)

1

Grade 1 (2)

Fatigue

2

1

Unlikely (2)

Possible (1)

1

Grade 1 (3)

Dry mouth

1

0

Possible (1)

1

Grade 1 (1)

Abdominal pain

1

3

Probable (1)

Possible (2)

Unlikely (1)

0.58

Grade 1 (4)

Rash maculo-papular

1

1

Unlikely (2)

1

Grade 1 (2)

Insomnia

1

0

Unlikely (1)

1

Grade 1 (1)

Upper respiratory infection

1

1

Unlikely (2)

1

Grade 1 (2)

Urinary frequency

1

0

Unlikely (1)

1

Grade 1 (1)

Muscle crampa,b

2

0

Possible (1)

Unlikely (1)

0.47

Grade 1 (2)

Chest pain - cardiac

0

1

Unlikely (1)

1

Grade 1 (1)

Tremorc

2

2

Possible (4)

1

Grade 1 (4)

Localized edema

0

1

Unlikely (1)

1

Grade 1 (1)

Extrapyramidal disorderd,e,f,g

3

1

Possible (4)

0.58

Grade 1 (4)

Gastrointestinal disorders - other - abdominal gas discomfort

1

1

Possible (1)

Probable (1)

1

Grade 1 (2)

Gastrointestinal disorders - other - increased salivation

0

1

Possible (1)

1

Grade 1 (1)

Metabolism and nutrition disorders - Decrease in blood glucose within normal rangeh

0

1

Possible (1)

1

Grade 1 (1)

Injury, poisoning and procedural complications - Contusion of ankle

1

0

Unrelated (1)

1

Grade 1 (1)

Injury, poisoning and procedural complications - Mild head trauma

0

1

Unlikely (1)

1

Grade 1 (1)

  1. P-values not corrected for multiple testing. Source data are provided as a Source Data file.
  2. aMultiple adverse events reported by one subject.
  3. bFormer medical history of dystonia. Increased muscle cramps one week after cessation of the study drug.
  4. cOne patient in each treatment group reported increased tremor in the first week after cessation of study drug. The other two reported increased tremor during study drug administration.
  5. dOne participant (NR) reported increased dyskinesia during the study, causing the participant to auto-reduce levodopa dosage.
  6. eOne participant (placebo) reported decreased dyskinesia during study.
  7. fOne participant (NR) reported increased rigidity one week after study drug cessation.
  8. gOne participant (NR) auto-reduced their levodopa dose during the study due to reduced subjective need of medication.
  9. hCaused diabetic participant to auto-reduce insulin dosage.
  10. iCommon Terminology Criteria for Adverse Events v5.0.
  11. jOne-sided Fisher’s exact test.
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