Trial Outcomes & Findings for Randomized Trial to Evaluate the Effectiveness of X-22 as a Smoking Cessation Aid (NCT NCT01400815)
NCT ID: NCT01400815
Last Updated: 2021-11-19
Results Overview
The primary efficacy measurement is the number of subjects with 4 weeks of continuous abstinence from smoking cigarettes (Weeks 7-10), as assessed by subject diary and confirmed by exhaled carbon monoxide (CO), after treatment termination, at Visits 6 and 7. A responder: did not smoke and had less than 10 ppm exhaled CO.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
234 participants
Primary outcome timeframe
Weeks 7 and 9 = telephone call, Week 8 = visit 6 and Week 10 = visit 7
Results posted on
2021-11-19
Participant Flow
Participant milestones
| Measure |
X-22 Smoking Cessation Product
The X-22 Smoking Cessation Product is a tobacco-based (botanical) medical product consisting of very low nicotine (VLN) cigarettes.
X-22 Smoking Cessation Product: The X-22 Smoking Cessation Product is a tobacco-based (botanical) medical product consisting of very low nicotine (VLN) cigarettes.
Subjects will be allowed to smoke as much as desired throughout the 6-week treatment period.
|
Active Control Cigarette
The Active Control cigarette is identical to the X-22 cigarette except for the tobacco, which has a nicotine content similar to that of a conventional "light" cigarette.
Active Control Cigarettes: The Active Control cigarette is identical to the X-22 cigarette except for the tobacco, which has a nicotine content similar to that of a conventional "light" cigarette.
Subjects will be allowed to smoke as much as desired throughout the 6-week treatment period.
|
|---|---|---|
|
Overall Study
STARTED
|
118
|
116
|
|
Overall Study
COMPLETED
|
80
|
95
|
|
Overall Study
NOT COMPLETED
|
38
|
21
|
Reasons for withdrawal
| Measure |
X-22 Smoking Cessation Product
The X-22 Smoking Cessation Product is a tobacco-based (botanical) medical product consisting of very low nicotine (VLN) cigarettes.
X-22 Smoking Cessation Product: The X-22 Smoking Cessation Product is a tobacco-based (botanical) medical product consisting of very low nicotine (VLN) cigarettes.
Subjects will be allowed to smoke as much as desired throughout the 6-week treatment period.
|
Active Control Cigarette
The Active Control cigarette is identical to the X-22 cigarette except for the tobacco, which has a nicotine content similar to that of a conventional "light" cigarette.
Active Control Cigarettes: The Active Control cigarette is identical to the X-22 cigarette except for the tobacco, which has a nicotine content similar to that of a conventional "light" cigarette.
Subjects will be allowed to smoke as much as desired throughout the 6-week treatment period.
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
0
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
18
|
11
|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
15
|
8
|
|
Overall Study
Subject in jail
|
1
|
0
|
Baseline Characteristics
Randomized Trial to Evaluate the Effectiveness of X-22 as a Smoking Cessation Aid
Baseline characteristics by cohort
| Measure |
X-22 Smoking Cessation Product
n=118 Participants
The X-22 Smoking Cessation Product is a tobacco-based (botanical) medical product consisting of very low nicotine (VLN) cigarettes.
X-22 Smoking Cessation Product: The X-22 Smoking Cessation Product is a tobacco-based (botanical) medical product consisting of very low nicotine (VLN) cigarettes.
Subjects will be allowed to smoke as much as desired throughout the 6-week treatment period.
|
Active Control Cigarette
n=116 Participants
The Active Control cigarette is identical to the X-22 cigarette except for the tobacco, which has a nicotine content similar to that of a conventional "light" cigarette.
Active Control Cigarettes: The Active Control cigarette is identical to the X-22 cigarette except for the tobacco, which has a nicotine content similar to that of a conventional "light" cigarette.
Subjects will be allowed to smoke as much as desired throughout the 6-week treatment period.
|
Total
n=234 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.1 Years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
41.8 Years
STANDARD_DEVIATION 11.2 • n=7 Participants
|
41.9 Years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
64 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
26 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
88 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
169 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Weeks 7 and 9 = telephone call, Week 8 = visit 6 and Week 10 = visit 7Population: intent to treat (ITT) population
The primary efficacy measurement is the number of subjects with 4 weeks of continuous abstinence from smoking cigarettes (Weeks 7-10), as assessed by subject diary and confirmed by exhaled carbon monoxide (CO), after treatment termination, at Visits 6 and 7. A responder: did not smoke and had less than 10 ppm exhaled CO.
Outcome measures
| Measure |
X-22 Smoking Cessation Product
n=118 Participants
The X-22 Smoking Cessation Product is a tobacco-based (botanical) medical product consisting of very low nicotine (VLN) cigarettes.
X-22 Smoking Cessation Product: The X-22 Smoking Cessation Product is a tobacco-based (botanical) medical product consisting of very low nicotine (VLN) cigarettes.
Subjects will be allowed to smoke as much as desired throughout the 6-week treatment period.
|
Active Control Cigarette
n=116 Participants
The Active Control cigarette is identical to the X-22 cigarette except for the tobacco, which has a nicotine content similar to that of a conventional "light" cigarette.
Active Control Cigarettes: The Active Control cigarette is identical to the X-22 cigarette except for the tobacco, which has a nicotine content similar to that of a conventional "light" cigarette.
Subjects will be allowed to smoke as much as desired throughout the 6-week treatment period.
|
|---|---|---|
|
Efficacy - 4 Weeks of Continuous Abstinence From Smoking Cigarettes
Week 8 - No Cigarettes Smoked per Diary (Weeks 7 and 8)
|
14 Participants
|
14 Participants
|
|
Efficacy - 4 Weeks of Continuous Abstinence From Smoking Cigarettes
Week 8 - Exhaled CO <= 10ppm
|
32 Participants
|
36 Participants
|
|
Efficacy - 4 Weeks of Continuous Abstinence From Smoking Cigarettes
Week 8 responder
|
14 Participants
|
11 Participants
|
|
Efficacy - 4 Weeks of Continuous Abstinence From Smoking Cigarettes
Week 10 - No Cigarettes Smoked per Diary (Weeks 9 and 10)
|
16 Participants
|
18 Participants
|
|
Efficacy - 4 Weeks of Continuous Abstinence From Smoking Cigarettes
Week 10 - Exhaled CO <= 10ppm
|
38 Participants
|
30 Participants
|
|
Efficacy - 4 Weeks of Continuous Abstinence From Smoking Cigarettes
Week 10 responder
|
16 Participants
|
13 Participants
|
|
Efficacy - 4 Weeks of Continuous Abstinence From Smoking Cigarettes
Overall Responder
|
13 Participants
|
10 Participants
|
Adverse Events
X-22 Smoking Cessation Product
Serious events: 5 serious events
Other events: 60 other events
Deaths: 0 deaths
Active Control Cigarette
Serious events: 1 serious events
Other events: 58 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
X-22 Smoking Cessation Product
n=118 participants at risk
The X-22 Smoking Cessation Product is a tobacco-based (botanical) medical product consisting of very low nicotine (VLN) cigarettes.
X-22 Smoking Cessation Product: The X-22 Smoking Cessation Product is a tobacco-based (botanical) medical product consisting of very low nicotine (VLN) cigarettes.
Subjects will be allowed to smoke as much as desired throughout the 6-week treatment period.
|
Active Control Cigarette
n=116 participants at risk
The Active Control cigarette is identical to the X-22 cigarette except for the tobacco, which has a nicotine content similar to that of a conventional "light" cigarette.
Active Control Cigarettes: The Active Control cigarette is identical to the X-22 cigarette except for the tobacco, which has a nicotine content similar to that of a conventional "light" cigarette.
Subjects will be allowed to smoke as much as desired throughout the 6-week treatment period.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal hernia obstructive
|
0.85%
1/118 • Number of events 1
|
0.00%
0/116
|
|
Infections and infestations
Sepsis
|
0.00%
0/118
|
0.86%
1/116 • Number of events 1
|
|
Injury, poisoning and procedural complications
Head injury
|
0.85%
1/118 • Number of events 1
|
0.00%
0/116
|
|
Injury, poisoning and procedural complications
Traumatic coma
|
0.85%
1/118 • Number of events 1
|
0.00%
0/116
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.85%
1/118 • Number of events 1
|
0.00%
0/116
|
|
Psychiatric disorders
Alcoholism
|
0.85%
1/118 • Number of events 1
|
0.00%
0/116
|
Other adverse events
| Measure |
X-22 Smoking Cessation Product
n=118 participants at risk
The X-22 Smoking Cessation Product is a tobacco-based (botanical) medical product consisting of very low nicotine (VLN) cigarettes.
X-22 Smoking Cessation Product: The X-22 Smoking Cessation Product is a tobacco-based (botanical) medical product consisting of very low nicotine (VLN) cigarettes.
Subjects will be allowed to smoke as much as desired throughout the 6-week treatment period.
|
Active Control Cigarette
n=116 participants at risk
The Active Control cigarette is identical to the X-22 cigarette except for the tobacco, which has a nicotine content similar to that of a conventional "light" cigarette.
Active Control Cigarettes: The Active Control cigarette is identical to the X-22 cigarette except for the tobacco, which has a nicotine content similar to that of a conventional "light" cigarette.
Subjects will be allowed to smoke as much as desired throughout the 6-week treatment period.
|
|---|---|---|
|
Blood and lymphatic system disorders
Blood disorder
|
0.00%
0/118
|
0.86%
1/116 • Number of events 1
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.85%
1/118 • Number of events 1
|
0.00%
0/116
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/118
|
0.86%
1/116 • Number of events 1
|
|
Ear and labyrinth disorders
Ear Pain
|
0.00%
0/118
|
0.86%
1/116 • Number of events 1
|
|
Ear and labyrinth disorders
Tympanic membrane perforation
|
0.00%
0/118
|
0.86%
1/116 • Number of events 1
|
|
Endocrine disorders
Hypothyroidism
|
0.85%
1/118 • Number of events 1
|
0.86%
1/116 • Number of events 1
|
|
Eye disorders
Astigmatism
|
0.85%
1/118 • Number of events 1
|
0.00%
0/116
|
|
Eye disorders
Dark circles under eyes
|
0.85%
1/118 • Number of events 1
|
0.00%
0/116
|
|
Eye disorders
Myopia
|
0.85%
1/118 • Number of events 1
|
0.00%
0/116
|
|
Eye disorders
Retinal disorder
|
0.00%
0/118
|
0.86%
1/116 • Number of events 1
|
|
Eye disorders
Visual impairment
|
0.00%
0/118
|
0.86%
1/116 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/118
|
0.86%
1/116 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal hernia obstructive
|
0.85%
1/118 • Number of events 1
|
0.00%
0/116
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/118
|
0.86%
1/116 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/118
|
1.7%
2/116 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/118
|
3.4%
4/116 • Number of events 4
|
|
Gastrointestinal disorders
Diarrhoea
|
0.85%
1/118 • Number of events 1
|
0.00%
0/116
|
|
Gastrointestinal disorders
Dyspepsia
|
1.7%
2/118 • Number of events 2
|
0.00%
0/116
|
|
Gastrointestinal disorders
Food poisoning
|
1.7%
2/118 • Number of events 2
|
0.00%
0/116
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/118
|
0.86%
1/116 • Number of events 1
|
|
Gastrointestinal disorders
Gingivitis
|
0.85%
1/118 • Number of events 1
|
0.00%
0/116
|
|
Gastrointestinal disorders
Nausea
|
1.7%
2/118 • Number of events 2
|
0.86%
1/116 • Number of events 1
|
|
Gastrointestinal disorders
Oral Pain
|
0.85%
1/118 • Number of events 1
|
0.00%
0/116
|
|
Gastrointestinal disorders
Tooth loss
|
0.00%
0/118
|
0.86%
1/116 • Number of events 1
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/118
|
0.86%
1/116 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
1.7%
2/118 • Number of events 2
|
0.00%
0/116
|
|
General disorders
Chest Pain
|
0.85%
1/118 • Number of events 1
|
0.86%
1/116 • Number of events 1
|
|
General disorders
Irritability
|
0.85%
1/118 • Number of events 1
|
0.00%
0/116
|
|
General disorders
Pyrexia
|
0.85%
1/118 • Number of events 1
|
0.00%
0/116
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/118
|
0.86%
1/116 • Number of events 1
|
|
Infections and infestations
Abscess
|
0.85%
1/118 • Number of events 1
|
0.00%
0/116
|
|
Infections and infestations
Bronchitis
|
0.85%
1/118 • Number of events 1
|
1.7%
2/116 • Number of events 2
|
|
Infections and infestations
Cellulitis
|
0.85%
1/118 • Number of events 1
|
0.00%
0/116
|
|
Infections and infestations
Ear infection
|
0.00%
0/118
|
0.86%
1/116 • Number of events 1
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/118
|
0.86%
1/116 • Number of events 1
|
|
Infections and infestations
Groin abscess
|
0.00%
0/118
|
0.86%
1/116 • Number of events 1
|
|
Infections and infestations
Influenza
|
0.85%
1/118 • Number of events 1
|
0.00%
0/116
|
|
Infections and infestations
Kidney infection
|
0.00%
0/118
|
0.86%
1/116 • Number of events 1
|
|
Infections and infestations
Laryngitis
|
1.7%
2/118 • Number of events 2
|
0.00%
0/116
|
|
Infections and infestations
Localised infection
|
0.85%
1/118 • Number of events 1
|
0.00%
0/116
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/118
|
1.7%
2/116 • Number of events 2
|
|
Infections and infestations
Nasopharyngitis
|
16.9%
20/118 • Number of events 20
|
14.7%
17/116 • Number of events 17
|
|
Infections and infestations
Oral herpes
|
0.00%
0/118
|
0.86%
1/116 • Number of events 1
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/118
|
0.86%
1/116 • Number of events 1
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/118
|
0.86%
1/116 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
0.00%
0/118
|
0.86%
1/116 • Number of events 1
|
|
Infections and infestations
Post procedural infection
|
0.85%
1/118 • Number of events 1
|
0.00%
0/116
|
|
Infections and infestations
Sepsis
|
0.00%
0/118
|
0.86%
1/116 • Number of events 1
|
|
Infections and infestations
Sinusitis
|
1.7%
2/118 • Number of events 2
|
2.6%
3/116 • Number of events 3
|
|
Infections and infestations
Tooth infection
|
2.5%
3/118 • Number of events 3
|
0.00%
0/116
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/118
|
0.86%
1/116 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/118
|
0.86%
1/116 • Number of events 1
|
|
Infections and infestations
Varicella
|
0.85%
1/118 • Number of events 1
|
0.00%
0/116
|
|
Injury, poisoning and procedural complications
Ear Injury
|
0.85%
1/118 • Number of events 1
|
0.00%
0/116
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.85%
1/118 • Number of events 1
|
0.00%
0/116
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.85%
1/118 • Number of events 1
|
0.00%
0/116
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/118
|
0.86%
1/116 • Number of events 1
|
|
Injury, poisoning and procedural complications
Head injury
|
1.7%
2/118 • Number of events 2
|
0.00%
0/116
|
|
Injury, poisoning and procedural complications
Joint sprain
|
1.7%
2/118 • Number of events 2
|
1.7%
2/116 • Number of events 2
|
|
Injury, poisoning and procedural complications
Laceration
|
2.5%
3/118 • Number of events 3
|
0.00%
0/116
|
|
Injury, poisoning and procedural complications
Limb Injury
|
0.00%
0/118
|
0.86%
1/116 • Number of events 1
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/118
|
0.86%
1/116 • Number of events 1
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.85%
1/118 • Number of events 1
|
0.00%
0/116
|
|
Injury, poisoning and procedural complications
Traumatic coma
|
0.85%
1/118 • Number of events 1
|
0.00%
0/116
|
|
Investigations
Blood carbon monoxide increased
|
0.85%
1/118 • Number of events 1
|
0.00%
0/116
|
|
Investigations
Blood creatinine increased
|
0.00%
0/118
|
0.86%
1/116 • Number of events 1
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/118
|
0.86%
1/116 • Number of events 1
|
|
Investigations
Blood potassium increased
|
0.85%
1/118 • Number of events 1
|
0.86%
1/116 • Number of events 1
|
|
Investigations
Blood pressure increased
|
0.85%
1/118 • Number of events 1
|
1.7%
2/116 • Number of events 2
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.85%
1/118 • Number of events 1
|
0.86%
1/116 • Number of events 1
|
|
Investigations
Haematocrit decreased
|
0.00%
0/118
|
0.86%
1/116 • Number of events 1
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/118
|
0.86%
1/116 • Number of events 1
|
|
Investigations
Red blood cell count decreased
|
0.00%
0/118
|
0.86%
1/116 • Number of events 1
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.85%
1/118 • Number of events 1
|
0.00%
0/116
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.85%
1/118 • Number of events 1
|
0.00%
0/116
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.85%
1/118 • Number of events 1
|
0.00%
0/116
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.85%
1/118 • Number of events 1
|
0.00%
0/116
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/118
|
0.86%
1/116 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.85%
1/118 • Number of events 1
|
0.00%
0/116
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.85%
1/118 • Number of events 1
|
0.00%
0/116
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.7%
2/118 • Number of events 2
|
1.7%
2/116 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/118
|
0.86%
1/116 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.85%
1/118 • Number of events 1
|
0.00%
0/116
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.85%
1/118 • Number of events 1
|
0.00%
0/116
|
|
Nervous system disorders
Dizziness
|
2.5%
3/118 • Number of events 3
|
0.86%
1/116 • Number of events 1
|
|
Nervous system disorders
Dysgeusia
|
0.85%
1/118 • Number of events 1
|
0.00%
0/116
|
|
Nervous system disorders
Headache
|
4.2%
5/118 • Number of events 5
|
6.9%
8/116 • Number of events 8
|
|
Nervous system disorders
Nerve compression
|
0.00%
0/118
|
0.86%
1/116 • Number of events 1
|
|
Nervous system disorders
Sinus headache
|
0.85%
1/118 • Number of events 1
|
0.86%
1/116 • Number of events 1
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.85%
1/118 • Number of events 1
|
0.00%
0/116
|
|
Psychiatric disorders
Alcoholism
|
0.85%
1/118 • Number of events 1
|
0.00%
0/116
|
|
Psychiatric disorders
Anxiety
|
1.7%
2/118 • Number of events 2
|
0.00%
0/116
|
|
Psychiatric disorders
Attention deficit/hyperactivity disorder
|
0.00%
0/118
|
1.7%
2/116 • Number of events 2
|
|
Psychiatric disorders
Depression
|
0.00%
0/118
|
0.86%
1/116 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/118
|
1.7%
2/116 • Number of events 2
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/118
|
0.86%
1/116 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.9%
7/118 • Number of events 7
|
6.0%
7/116 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/118
|
0.86%
1/116 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Increased upper airway secretion
|
0.85%
1/118 • Number of events 1
|
0.00%
0/116
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
4.2%
5/118 • Number of events 5
|
2.6%
3/116 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/118
|
4.3%
5/116 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
1.7%
2/118 • Number of events 2
|
1.7%
2/116 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/118
|
1.7%
2/116 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/118
|
0.86%
1/116 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/118
|
2.6%
3/116 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/118
|
0.86%
1/116 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/118
|
0.86%
1/116 • Number of events 1
|
|
Vascular disorders
Hypertension
|
1.7%
2/118 • Number of events 2
|
1.7%
2/116 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The PI's have a general obligation of confidentiality, which extends to the study results and data procured under the study. There are exceptions to this obligation of confidentiality, which include the disclosure of study information and results in connection with publication and is necessary for the medical care of a study subject.
- Publication restrictions are in place
Restriction type: OTHER