Study: NCT03492463

Adverse event: Knee Surgery
Serious: yes
Organ System: Surgical and medical procedures
Notes: Knee arthritis resulted in knee instability resulted in fall resulted in knee surgery required hospitalization. Medical determination: not study related.
Frequency: 1 affected / 37 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Recurrent COPD exacerbation with hospitalization. The participant had two COPD exacerbations within 9 months of starting the study and 1 COPD exacerbation during study, but prior to initiating product use. Medical determination: not study related.
Frequency: 1 affected / 37 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 37 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 37 at risk

Adverse event: Abnormal dreams
Serious: no
Organ System: General disorders
Frequency: 7 affected / 37 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 2 affected / 37 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 37 at risk

Adverse event: Itchiness
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Itchiness at the site of the nicotine or placebo patch
Frequency: 8 affected / 37 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 37 at risk

Adverse event: Streptococcal Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Strep throat resulted in likely streptococcal pneumonia with hospitalization. Medical determination: not study related.
Frequency: 1 affected / 33 at risk

Adverse event: Hallucination, auditory
Serious: yes
Organ System: Psychiatric disorders
Notes: Poly-substance use with caffeine, THC, kava kava, alcohol and kratom resulted in auditory hallucinations requiring hospitalization. Medical determination: not study related.
Frequency: 1 affected / 33 at risk

Adverse event: Hypertensive crisis
Serious: yes
Organ System: Vascular disorders
Notes: Hypertensive crisis (BP 245/130) occurred in a patient with a history of hypertension and resolved after treatment in the emergency room. Medical determination: not study related.
Frequency: 1 affected / 33 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 33 at risk

Adverse event: Abnormal dreams
Serious: no
Organ System: General disorders
Frequency: 6 affected / 33 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 33 at risk

Adverse event: Itchiness
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Itchiness at the site of the nicotine or placebo patch
Frequency: 3 affected / 33 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 33 at risk

Adverse event: Local Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Rash at site of nicotine or placebo patch
Frequency: 2 affected / 33 at risk

Adverse event: Distant Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Rash not at the site of the nicotine or placebo patch
Frequency: 3 affected / 33 at risk

Adverse event: Infected renal stone
Serious: yes
Organ System: Renal and urinary disorders
Notes: Infected renal stones requiring hospitalization. Medical determination: not study related.
Frequency: 1 affected / 11 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Abnormal dreams
Serious: no
Organ System: General disorders
Frequency: 3 affected / 11 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Rapid Heart Beat
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 11 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 11 at risk

Adverse event: Itchiness
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Itchiness at the site of the nicotine or placebo patch
Frequency: 1 affected / 11 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 11 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 11 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Dizziness
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 13 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Abnormal dreams
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Itchiness
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Itchiness at the site of the nicotine or placebo patch
Frequency: 1 affected / 13 at risk