Study: NCT03276780

Adverse event: Undisclosed Virus
Serious: yes
Organ System: General disorders
Notes: Participant reported being hospitalized to be treated for an undisclosed virus between sessions.
Frequency: 1 affected / 41 at risk

Adverse event: Nasal discomfort
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Occurred while using the nicotine nasal spray.
Frequency: 1 affected / 41 at risk

Adverse event: Throat irritation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Occurred while using the nicotine nasal spray.
Frequency: 2 affected / 41 at risk

Adverse event: Nasal Drainage
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Occurred while using the nicotine nasal spray.
Frequency: 1 affected / 41 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Occurred while using the nicotine nasal spray. 1 instance occurred without any NRT use (not related to study medication).
Frequency: 2 affected / 41 at risk

Adverse event: Excessive Sneezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Occurred while using the nicotine nasal spray.
Frequency: 2 affected / 41 at risk

Adverse event: Nicotine Dosage Too Strong
Serious: no
Organ System: General disorders
Notes: Occurred while using the nicotine gum.
Frequency: 1 affected / 41 at risk

Adverse event: Vivid Dreams/Nightmares
Serious: no
Organ System: General disorders
Notes: Occurred while using either the 21 mg patch or 14 mg patch.
Frequency: 4 affected / 41 at risk

Adverse event: Burning Mouth/Throat
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Occurred while using the 2 mg or 4 mg nicotine lozenges/gum or the nicotine inhaler
Frequency: 1 affected / 41 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Occurred while using the 21 mg or 14 mg nicotine patch. 1 participant reported an unrelated neck rash while using the 4 mg and 2 mg nicotine lozenges.
Frequency: 2 affected / 41 at risk

Adverse event: Excessive Coughing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Occurred when using the nicotine inhaler.
Frequency: 1 affected / 41 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: Occurred when using the nicotine patches and nicotine lozenges in combination, as well as when using the nicotine inhaler.
Frequency: 2 affected / 41 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Occurred after using the nicotine patch, nicotine inhaler, nicotine gum, and nicotine lozenges.
Frequency: 3 affected / 41 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Occurred when using the nicotine replacement products.
Frequency: 4 affected / 41 at risk

Adverse event: Nasal discomfort
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Occurred when using the nicotine nasal spray.
Frequency: 1 affected / 41 at risk

Adverse event: Nasal Tingling
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Occurred when using the nicotine nasal spray.
Frequency: 1 affected / 41 at risk

Adverse event: Feeling jittery
Serious: no
Organ System: General disorders
Notes: Occurred when using the nicotine inhaler.
Frequency: 1 affected / 41 at risk

Adverse event: Nasal Blistering
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Occurred when using the nicotine nasal spray.
Frequency: 1 affected / 41 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Eye disorders
Notes: Occurred when using the nicotine nasal spray.
Frequency: 1 affected / 41 at risk

Adverse event: Increased Heart Rate
Serious: no
Organ System: General disorders
Notes: Occurred when using the nicotine nasal spray.
Frequency: 1 affected / 41 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: A participant reported being treated for an upper respiratory infection. This infection was unrelated to the participant using any study NRT medication.
Frequency: 1 affected / 41 at risk

Adverse event: Toothache
Serious: no
Organ System: General disorders
Notes: Participant reported tooth pain during session that was not related to using the study NRT medication.
Frequency: 1 affected / 41 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Participant was hospitalized for treatment for pneumonia between baseline and the first intervention session. Participant was unable to complete the first intervention session for 3 weeks.
Frequency: 1 affected / 39 at risk

Adverse event: Severe Depression
Serious: yes
Organ System: Psychiatric disorders
Notes: Participant was admitted to inpatient psychiatric treatment for symptoms of depression between baseline and the first intervention session. Participant was unable to complete the first intervention session for 3 weeks.
Frequency: 1 affected / 39 at risk

Adverse event: Burning Mouth/Throat
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Occurred while using the 2 mg or 4 mg nicotine lozenges/gum or the nicotine inhaler
Frequency: 1 affected / 39 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Occurred while using the 21 mg or 14 mg nicotine patch. 1 participant reported an unrelated neck rash while using the 4 mg and 2 mg nicotine lozenges.
Frequency: 1 affected / 39 at risk

Adverse event: Excessive Coughing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Occurred when using the nicotine inhaler.
Frequency: 1 affected / 39 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: Occurred when using the nicotine patches and nicotine lozenges in combination, as well as when using the nicotine inhaler.
Frequency: 1 affected / 39 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Notes: Occurred when using the nicotine patches and nicotine lozenges in combination.
Frequency: 1 affected / 39 at risk