Study: NCT02148445

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Notes: Arrhythmia resulting in hospitalization or placement/modification of a device, but not a pacemaker for bradycardia
Frequency: 1 affected / 198 at risk

Adverse event: Hospitalization for CHF
Serious: yes
Organ System: Cardiac disorders
Notes: Hospitalization for Congestive Heart Failure
Frequency: 2 affected / 198 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Cardiac disorders
Notes: TIA with hospitalization
Frequency: 1 affected / 198 at risk

Adverse event: Revascularization
Serious: yes
Organ System: Cardiac disorders
Notes: Revascularization - either a CABG or angioplasty/stent due to increasing ischemia
Frequency: 3 affected / 198 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Cardiac disorders
Notes: Stroke with signs of sustained neurologic dysfunction
Frequency: 1 affected / 198 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Notes: Unstable angina requiring hospitalization
Frequency: 1 affected / 198 at risk

Adverse event: Local skin reactions
Serious: no
Organ System: Product Issues
Notes: Local skin reactions from the nicotine patch
Frequency: 44 affected / 198 at risk

Adverse event: Upper GI symptoms
Serious: no
Organ System: Product Issues
Notes: Including heartburn, indigestion, nausea, upset stomatch
Frequency: 32 affected / 198 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: Product Issues
Notes: Including problems sleeping or vivid dreams
Frequency: 23 affected / 198 at risk

Adverse event: Oral discomfort
Serious: no
Organ System: Product Issues
Notes: Including sore throat, pain, blisters in mouth or jaw, dry mouth
Frequency: 13 affected / 198 at risk

Adverse event: Headache
Serious: no
Organ System: Product Issues
Frequency: 7 affected / 198 at risk

Adverse event: Change in affect or state of arousal
Serious: no
Organ System: Product Issues
Notes: including feeling jittery, nervous, anxious, restless, irritable, experiencing depressed mood, tiredness, sleepiness, fatigue
Frequency: 12 affected / 198 at risk

Adverse event: Cardiovascular symptoms
Serious: no
Organ System: Product Issues
Notes: Including change in blood pressure, heart rate, not a major cardiac event (MACE)
Frequency: 7 affected / 198 at risk

Adverse event: Hiccups
Serious: no
Organ System: Product Issues
Frequency: 7 affected / 198 at risk

Adverse event: Muscle Aches
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 198 at risk

Adverse event: Bad Taste in Mouth
Serious: no
Organ System: Product Issues
Notes: Often reported as "nicotine taste in mouth"
Frequency: 4 affected / 198 at risk

Adverse event: Dizziness
Serious: no
Organ System: Product Issues
Frequency: 3 affected / 198 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Product Issues
Frequency: 4 affected / 198 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Notes: Arrhythmia resulting in hospitalization or placement/modification of a device, but not a pacemaker for bradycardia
Frequency: 3 affected / 200 at risk

Adverse event: Hospitalization for CHF
Serious: yes
Organ System: Cardiac disorders
Notes: Hospitalization for Congestive Heart Failure
Frequency: 2 affected / 200 at risk

Adverse event: Intestinal ischaemia
Serious: yes
Organ System: Cardiac disorders
Notes: Mesenteric Ischemia with death
Frequency: 1 affected / 200 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: Myocardial Infarction would require hospitalization with elevated troponin
Frequency: 1 affected / 200 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Cardiac disorders
Notes: TIA with hospitalization
Frequency: 1 affected / 200 at risk

Adverse event: Local skin reactions
Serious: no
Organ System: Product Issues
Notes: Local skin reactions from the nicotine patch
Frequency: 81 affected / 200 at risk

Adverse event: Upper GI symptoms
Serious: no
Organ System: Product Issues
Notes: Including heartburn, indigestion, nausea, upset stomatch
Frequency: 62 affected / 200 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: Product Issues
Notes: Including problems sleeping or vivid dreams
Frequency: 41 affected / 200 at risk

Adverse event: Oral discomfort
Serious: no
Organ System: Product Issues
Notes: Including sore throat, pain, blisters in mouth or jaw, dry mouth
Frequency: 26 affected / 200 at risk

Adverse event: Headache
Serious: no
Organ System: Product Issues
Frequency: 18 affected / 200 at risk

Adverse event: Change in affect or state of arousal
Serious: no
Organ System: Product Issues
Notes: including feeling jittery, nervous, anxious, restless, irritable, experiencing depressed mood, tiredness, sleepiness, fatigue
Frequency: 20 affected / 200 at risk

Adverse event: Cardiovascular symptoms
Serious: no
Organ System: Product Issues
Notes: Including change in blood pressure, heart rate, not a major cardiac event (MACE)
Frequency: 13 affected / 200 at risk

Adverse event: Hiccups
Serious: no
Organ System: Product Issues
Frequency: 11 affected / 200 at risk

Adverse event: Muscle Aches
Serious: no
Organ System: Product Issues
Frequency: 6 affected / 200 at risk

Adverse event: Bad Taste in Mouth
Serious: no
Organ System: Product Issues
Notes: Often reported as "nicotine taste in mouth"
Frequency: 11 affected / 200 at risk

Adverse event: Dizziness
Serious: no
Organ System: Product Issues
Frequency: 11 affected / 200 at risk

Adverse event: Increased Sweating
Serious: no
Organ System: Product Issues
Notes: Including night sweats
Frequency: 7 affected / 200 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Product Issues
Frequency: 6 affected / 200 at risk