Study: NCT01368653

Adverse event: Broken toe
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Participant reported an injury that broke a toe and said that she was hospitalized overnight for observation. Participant reported using study medication (nicotine patch) at the time of the injury.
Frequency: 1 affected / 47 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Participant reported experiencing chest pain; she went to an emergency dept., had an ECG, and cardiac catheterization before leaving with a negative diagnosis for cardiac disorder. She was given esomeprazole and sucralfate and an endoscopy order.
Frequency: 1 affected / 47 at risk

Adverse event: Leg and back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Participant reported leg and back pain worsening over three months that prompted an emergency dept. visit and hospitalization for MRI and plethysmography; left with pain medication.
Frequency: 1 affected / 47 at risk

Adverse event: Respiratory infection, congestion, or illness
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Symptoms of nasal or sinus congestion, sore throat, asthma (in previously diagnosed individuals), and mild shortness of breath.
Frequency: 6 affected / 47 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cough, whether dry or productive, is presented separately from other respiratory symptoms due to its potential relation to quitting smoking.
Frequency: 8 affected / 47 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: Psychiatric disorders
Notes: Mild sleep disturbance (difficulty falling asleep, vivid dreams, waking in the night).
Frequency: 5 affected / 47 at risk

Adverse event: Gastrointestinal symptoms
Serious: no
Organ System: Gastrointestinal disorders
Notes: Heartburn, nausea, abdominal pain or cramping.
Frequency: 5 affected / 47 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: Headaches, including migraine headaches.
Frequency: 4 affected / 47 at risk

Adverse event: Skin irritation, rash, or pain
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Transdermal nicotine patches were provided to all participants and skin irritation, redness, rash, or discomfort at the patch site was reported by some participants.
Frequency: 5 affected / 47 at risk

Adverse event: Dizziness or lightheadedness
Serious: no
Organ System: General disorders
Notes: Feeling dizzy, lightheaded, or faint.
Frequency: 4 affected / 47 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Tiredness, fatigue, sleepiness.
Frequency: 3 affected / 47 at risk

Adverse event: Tooth abscess
Serious: yes
Organ System: Infections and infestations
Notes: Tooth abscess requiring emergency surgery and overnight hospitalization
Frequency: 1 affected / 46 at risk

Adverse event: Upper GI tract disorder
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Participant reported that he was hospitalized for severe upper gastrointestinal tract problems, had an endoscopy, and was prescribed new medication. Participant was not on study medication at the time of his symptoms or hospitalization.
Frequency: 1 affected / 46 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Participant experienced nausea, vomiting, abdominal pain; was admitted to hospital, diagnosed with a bowel obstruction, treated, and released after 5 days.
Frequency: 1 affected / 46 at risk

Adverse event: Respiratory distress, diabetes, and dehydration
Serious: yes
Organ System: General disorders
Notes: At follow-up, participant reported 4 emergency dept. visits and hospitalization for varied symptoms (cough, chills, nausea, abdominal pain, headache) and said she was treated for dehydration, had her insulin for DM-II adjusted, and had a procedure.
Frequency: 1 affected / 46 at risk

Adverse event: Respiratory infection, congestion, or illness
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Symptoms of nasal or sinus congestion, sore throat, asthma (in previously diagnosed individuals), and mild shortness of breath.
Frequency: 7 affected / 46 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cough, whether dry or productive, is presented separately from other respiratory symptoms due to its potential relation to quitting smoking.
Frequency: 7 affected / 46 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: Psychiatric disorders
Notes: Mild sleep disturbance (difficulty falling asleep, vivid dreams, waking in the night).
Frequency: 6 affected / 46 at risk

Adverse event: Gastrointestinal symptoms
Serious: no
Organ System: Gastrointestinal disorders
Notes: Heartburn, nausea, abdominal pain or cramping.
Frequency: 1 affected / 46 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: Headaches, including migraine headaches.
Frequency: 3 affected / 46 at risk

Adverse event: Skin irritation, rash, or pain
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Transdermal nicotine patches were provided to all participants and skin irritation, redness, rash, or discomfort at the patch site was reported by some participants.
Frequency: 3 affected / 46 at risk

Adverse event: Dizziness or lightheadedness
Serious: no
Organ System: General disorders
Notes: Feeling dizzy, lightheaded, or faint.
Frequency: 2 affected / 46 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Tiredness, fatigue, sleepiness.
Frequency: 2 affected / 46 at risk

Adverse event: Leg and back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Participant reported leg and back pain worsening over three months that prompted an emergency dept. visit and hospitalization for MRI and plethysmography; left with pain medication.
Frequency: 1 affected / 20 at risk

Adverse event: Respiratory distress, diabetes, and dehydration
Serious: yes
Organ System: General disorders
Notes: At follow-up, participant reported 4 emergency dept. visits and hospitalization for varied symptoms (cough, chills, nausea, abdominal pain, headache) and said she was treated for dehydration, had her insulin for DM-II adjusted, and had a procedure.
Frequency: 1 affected / 20 at risk

Adverse event: Respiratory infection, congestion, or illness
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Symptoms of nasal or sinus congestion, sore throat, asthma (in previously diagnosed individuals), and mild shortness of breath.
Frequency: 3 affected / 20 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cough, whether dry or productive, is presented separately from other respiratory symptoms due to its potential relation to quitting smoking.
Frequency: 4 affected / 20 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: Psychiatric disorders
Notes: Mild sleep disturbance (difficulty falling asleep, vivid dreams, waking in the night).
Frequency: 4 affected / 20 at risk

Adverse event: Gastrointestinal symptoms
Serious: no
Organ System: Gastrointestinal disorders
Notes: Heartburn, nausea, abdominal pain or cramping.
Frequency: 1 affected / 20 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: Headaches, including migraine headaches.
Frequency: 1 affected / 20 at risk

Adverse event: Skin irritation, rash, or pain
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Transdermal nicotine patches were provided to all participants and skin irritation, redness, rash, or discomfort at the patch site was reported by some participants.
Frequency: 1 affected / 20 at risk

Adverse event: Tooth abscess
Serious: yes
Organ System: Infections and infestations
Notes: Tooth abscess requiring emergency surgery and overnight hospitalization
Frequency: 1 affected / 20 at risk

Adverse event: Upper GI tract disorder
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Participant reported that he was hospitalized for severe upper gastrointestinal tract problems, had an endoscopy, and was prescribed new medication. Participant was not on study medication at the time of his symptoms or hospitalization.
Frequency: 1 affected / 20 at risk

Adverse event: Respiratory infection, congestion, or illness
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Symptoms of nasal or sinus congestion, sore throat, asthma (in previously diagnosed individuals), and mild shortness of breath.
Frequency: 4 affected / 20 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cough, whether dry or productive, is presented separately from other respiratory symptoms due to its potential relation to quitting smoking.
Frequency: 4 affected / 20 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: Psychiatric disorders
Notes: Mild sleep disturbance (difficulty falling asleep, vivid dreams, waking in the night).
Frequency: 3 affected / 20 at risk

Adverse event: Gastrointestinal symptoms
Serious: no
Organ System: Gastrointestinal disorders
Notes: Heartburn, nausea, abdominal pain or cramping.
Frequency: 1 affected / 20 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: Headaches, including migraine headaches.
Frequency: 2 affected / 20 at risk

Adverse event: Skin irritation, rash, or pain
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Transdermal nicotine patches were provided to all participants and skin irritation, redness, rash, or discomfort at the patch site was reported by some participants.
Frequency: 4 affected / 20 at risk

Adverse event: Dizziness or lightheadedness
Serious: no
Organ System: General disorders
Notes: Feeling dizzy, lightheaded, or faint.
Frequency: 2 affected / 20 at risk