Trial Outcomes & Findings for Efficacy and Safety Trial of SLITone(TM) Birch in Subjects With Hayfever (NCT NCT00310466)
NCT ID: NCT00310466
Last Updated: 2013-05-14
Results Overview
A total of 6 rhinoconjunctivitis symptoms are recorded (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes, watery eyes). Each symptoms is scored on a scale from 0-3 (no symptoms-severe symptoms). I.e. the total daily score can be 0-18.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
226 participants
Primary outcome timeframe
Birch pollen season 2006
Results posted on
2013-05-14
Participant Flow
First patient first visit: 13 June 2005
Participant milestones
| Measure |
SLITone Birch
Birch pollen extract for sublingual administration
|
Placebo
Corresponding placebo for sublingual administration
|
|---|---|---|
|
Overall Study
STARTED
|
113
|
113
|
|
Overall Study
COMPLETED
|
95
|
101
|
|
Overall Study
NOT COMPLETED
|
18
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety Trial of SLITone(TM) Birch in Subjects With Hayfever
Baseline characteristics by cohort
| Measure |
SLITone Birch
n=113 Participants
Birch pollen extract for sublingual administration
|
Placebo
n=113 Participants
Corresponding placebo for sublingual administration
|
Total
n=226 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0.0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
113 Participants
n=5 Participants
|
113 Participants
n=7 Participants
|
226.0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0.0 Participants
n=5 Participants
|
|
Age Continuous
|
39.3 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
39.5 years
STANDARD_DEVIATION 11.5 • n=7 Participants
|
39.4 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
69 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
140.0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
86.0 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
113 participants
n=5 Participants
|
113 participants
n=7 Participants
|
226.0 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Birch pollen season 2006A total of 6 rhinoconjunctivitis symptoms are recorded (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes, watery eyes). Each symptoms is scored on a scale from 0-3 (no symptoms-severe symptoms). I.e. the total daily score can be 0-18.
Outcome measures
| Measure |
SLITone Birch
n=95 Participants
Birch pollen extract for sublingual administration
|
Placebo
n=101 Participants
Corresponding placebo for sublingual administration
|
|---|---|---|
|
Daily Rhinoconjunctivitis Symptom Score
|
4.07 Units on a scale (0-18)
Standard Deviation 2.59
|
4.14 Units on a scale (0-18)
Standard Deviation 2.56
|
PRIMARY outcome
Timeframe: Birch pollen season 2006Rescue medication (desloratadine tablets, budesonide nasal spray, prednisone tablets) used for treatment of rhinoconjunctivitis symptoms not controlled by the study medication, were recorded. The total daily score was 0-30 (No medication-Maximum use of medication).
Outcome measures
| Measure |
SLITone Birch
n=95 Participants
Birch pollen extract for sublingual administration
|
Placebo
n=101 Participants
Corresponding placebo for sublingual administration
|
|---|---|---|
|
Daily Rhinoconjunctivitis Rescue Medication Score
|
2.76 Units on a scale (0-30)
Standard Deviation 3.30
|
2.54 Units on a scale (0-30)
Standard Deviation 2.99
|
SECONDARY outcome
Timeframe: Birch pollen season 2006The number of participants who reported improved overall symptoms compared to the previous birch pollen season (each patient was asked to compare his/her symptoms in the 2006 birch pollen season with the symptoms in the 2005 birch pollen season).
Outcome measures
| Measure |
SLITone Birch
n=95 Participants
Birch pollen extract for sublingual administration
|
Placebo
n=101 Participants
Corresponding placebo for sublingual administration
|
|---|---|---|
|
Global Improvement of Rhinoconjunctivitis Symptoms Assessed by the Subjects
|
48 Participants
|
42 Participants
|
SECONDARY outcome
Timeframe: Birch pollen season 2006An adverse event was defined as: Any untoward medical occurence in a patient or clinical trial subject administered a trial product and which does not necessarily have a causal relationship with this treatment (International Conference of Harmonisation (ICH) Harmonised Tripartite Guideline E2A, Step 5).
Outcome measures
| Measure |
SLITone Birch
n=95 Participants
Birch pollen extract for sublingual administration
|
Placebo
n=101 Participants
Corresponding placebo for sublingual administration
|
|---|---|---|
|
Adverse Events
|
81 Events
|
87 Events
|
Adverse Events
SLITone Birch
Serious events: 4 serious events
Other events: 81 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 87 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SLITone Birch
n=113 participants at risk
Birch pollen extract for sublingual administration
|
Placebo
n=113 participants at risk
Corresponding placebo for sublingual administration
|
|---|---|---|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.88%
1/113 • Number of events 1
|
0.00%
0/113
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.88%
1/113 • Number of events 1
|
0.00%
0/113
|
|
Surgical and medical procedures
Cholecystectomy
|
0.88%
1/113 • Number of events 1
|
0.00%
0/113
|
|
Surgical and medical procedures
Tonsillectomy
|
0.88%
1/113 • Number of events 1
|
0.00%
0/113
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/113
|
0.88%
1/113 • Number of events 1
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/113
|
0.88%
1/113 • Number of events 1
|
Other adverse events
| Measure |
SLITone Birch
n=113 participants at risk
Birch pollen extract for sublingual administration
|
Placebo
n=113 participants at risk
Corresponding placebo for sublingual administration
|
|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
1.8%
2/113 • Number of events 2
|
0.00%
0/113
|
|
Cardiac disorders
Arrhytmia
|
0.00%
0/113
|
0.88%
1/113 • Number of events 1
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/113
|
0.88%
1/113 • Number of events 1
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/113
|
0.88%
1/113 • Number of events 1
|
|
Ear and labyrinth disorders
Ear pruritus
|
2.7%
3/113 • Number of events 3
|
0.88%
1/113 • Number of events 1
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/113
|
0.88%
1/113 • Number of events 1
|
|
Eye disorders
Abnormal sensation in eye
|
0.88%
1/113 • Number of events 1
|
0.00%
0/113
|
|
Eye disorders
Conjunctivitis
|
3.5%
4/113 • Number of events 5
|
0.00%
0/113
|
|
Eye disorders
Conjunctivitis allergic
|
0.88%
1/113 • Number of events 1
|
1.8%
2/113 • Number of events 2
|
|
Eye disorders
Eye irritation
|
0.88%
1/113 • Number of events 1
|
0.88%
1/113 • Number of events 1
|
|
Eye disorders
Eye pruritus
|
7.1%
8/113 • Number of events 10
|
6.2%
7/113 • Number of events 8
|
|
Eye disorders
Eye redness
|
0.00%
0/113
|
2.7%
3/113 • Number of events 3
|
|
Eye disorders
Eye swelling
|
1.8%
2/113 • Number of events 3
|
0.00%
0/113
|
|
Eye disorders
Lacrimation increased
|
1.8%
2/113 • Number of events 2
|
0.88%
1/113 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/113
|
1.8%
2/113 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/113
|
0.88%
1/113 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/113
|
0.88%
1/113 • Number of events 1
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.88%
1/113 • Number of events 2
|
0.00%
0/113
|
|
Gastrointestinal disorders
Cheilitis
|
0.88%
1/113 • Number of events 1
|
0.00%
0/113
|
|
Gastrointestinal disorders
Diarrhoea
|
1.8%
2/113 • Number of events 2
|
0.00%
0/113
|
|
Gastrointestinal disorders
Gastritis
|
0.88%
1/113 • Number of events 1
|
0.00%
0/113
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/113
|
0.88%
1/113 • Number of events 1
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.88%
1/113 • Number of events 1
|
0.00%
0/113
|
|
Gastrointestinal disorders
Intestinal polyp
|
0.00%
0/113
|
0.88%
1/113 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/113
|
1.8%
2/113 • Number of events 2
|
|
Gastrointestinal disorders
Oedema mouth
|
0.00%
0/113
|
0.88%
1/113 • Number of events 1
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/113
|
0.88%
1/113 • Number of events 1
|
|
Gastrointestinal disorders
Oral discomfort
|
9.7%
11/113 • Number of events 14
|
6.2%
7/113 • Number of events 8
|
|
Gastrointestinal disorders
Oral pruritus
|
32.7%
37/113 • Number of events 45
|
23.9%
27/113 • Number of events 31
|
|
Gastrointestinal disorders
Toothache
|
0.88%
1/113 • Number of events 1
|
0.88%
1/113 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
2.7%
3/113 • Number of events 3
|
0.00%
0/113
|
|
General disorders
Application site anaesthesia
|
0.00%
0/113
|
0.88%
1/113 • Number of events 1
|
|
General disorders
Application site eczema
|
0.00%
0/113
|
0.88%
1/113 • Number of events 1
|
|
General disorders
Application site papules
|
0.88%
1/113 • Number of events 1
|
0.00%
0/113
|
|
General disorders
Chest discomfort
|
0.88%
1/113 • Number of events 1
|
0.00%
0/113
|
|
General disorders
Fatigue
|
2.7%
3/113 • Number of events 3
|
1.8%
2/113 • Number of events 2
|
|
General disorders
Feeling cold
|
0.88%
1/113 • Number of events 1
|
1.8%
2/113 • Number of events 2
|
|
General disorders
Mucous membrane disorders
|
0.00%
0/113
|
0.88%
1/113 • Number of events 1
|
|
General disorders
Oedema mucosal
|
0.88%
1/113 • Number of events 1
|
0.00%
0/113
|
|
General disorders
Oedema peripheral
|
0.88%
1/113 • Number of events 1
|
0.00%
0/113
|
|
General disorders
Pyrexia
|
0.88%
1/113 • Number of events 1
|
0.88%
1/113 • Number of events 1
|
|
General disorders
Sensation of foreign body
|
0.00%
0/113
|
1.8%
2/113 • Number of events 2
|
|
Hepatobiliary disorders
Biliary colic
|
0.88%
1/113 • Number of events 1
|
0.00%
0/113
|
|
Immune system disorders
Allergy to arthropod sting
|
0.00%
0/113
|
0.88%
1/113 • Number of events 2
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/113
|
0.88%
1/113 • Number of events 1
|
|
Immune system disorders
Hypersensitivity
|
0.88%
1/113 • Number of events 1
|
2.7%
3/113 • Number of events 4
|
|
Immune system disorders
Seasonal allergy
|
1.8%
2/113 • Number of events 3
|
0.00%
0/113
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/113
|
0.88%
1/113 • Number of events 1
|
|
Infections and infestations
Bladder infection
|
0.00%
0/113
|
0.88%
1/113 • Number of events 1
|
|
Infections and infestations
Bronchitis
|
0.88%
1/113 • Number of events 1
|
3.5%
4/113 • Number of events 6
|
|
Infections and infestations
Cystitis
|
0.88%
1/113 • Number of events 1
|
1.8%
2/113 • Number of events 3
|
|
Infections and infestations
Folliculitis
|
0.00%
0/113
|
0.88%
1/113 • Number of events 1
|
|
Infections and infestations
Gastroenteritis
|
0.88%
1/113 • Number of events 1
|
0.00%
0/113
|
|
Infections and infestations
Gastrointestinal infection
|
0.88%
1/113 • Number of events 1
|
0.00%
0/113
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/113
|
0.88%
1/113 • Number of events 1
|
|
Infections and infestations
Herpes soster
|
1.8%
2/113 • Number of events 2
|
0.00%
0/113
|
|
Infections and infestations
Hordeolum
|
0.00%
0/113
|
1.8%
2/113 • Number of events 2
|
|
Infections and infestations
Infected naevus
|
0.00%
0/113
|
0.88%
1/113 • Number of events 1
|
|
Infections and infestations
Influenza
|
0.88%
1/113 • Number of events 1
|
2.7%
3/113 • Number of events 6
|
|
Infections and infestations
Laryngitis
|
0.88%
1/113 • Number of events 1
|
0.88%
1/113 • Number of events 1
|
|
Infections and infestations
Laryngitis viral
|
0.88%
1/113 • Number of events 1
|
0.00%
0/113
|
|
Infections and infestations
Localised infection
|
0.88%
1/113 • Number of events 1
|
0.00%
0/113
|
|
Infections and infestations
Nasopharyngitis
|
9.7%
11/113 • Number of events 17
|
13.3%
15/113 • Number of events 16
|
|
Infections and infestations
Otitis media
|
0.88%
1/113 • Number of events 2
|
0.00%
0/113
|
|
Infections and infestations
Pharyngitis
|
2.7%
3/113 • Number of events 3
|
0.00%
0/113
|
|
Infections and infestations
Pneumonia
|
0.88%
1/113 • Number of events 1
|
0.00%
0/113
|
|
Infections and infestations
Respiratory tract infection
|
1.8%
2/113 • Number of events 3
|
2.7%
3/113 • Number of events 4
|
|
Infections and infestations
Rhinitis infective
|
0.00%
0/113
|
1.8%
2/113 • Number of events 2
|
|
Infections and infestations
Sinobronchitis
|
0.88%
1/113 • Number of events 1
|
0.00%
0/113
|
|
Infections and infestations
Sinusitis
|
2.7%
3/113 • Number of events 5
|
4.4%
5/113 • Number of events 5
|
|
Infections and infestations
Tinea pedis
|
0.88%
1/113 • Number of events 1
|
0.00%
0/113
|
|
Infections and infestations
Tinea versicolour
|
0.88%
1/113 • Number of events 1
|
0.00%
0/113
|
|
Infections and infestations
Tonsilitis
|
0.88%
1/113 • Number of events 1
|
0.88%
1/113 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
3.5%
4/113 • Number of events 4
|
2.7%
3/113 • Number of events 3
|
|
Infections and infestations
Vaginitis
|
0.00%
0/113
|
0.88%
1/113 • Number of events 1
|
|
Infections and infestations
Viral diarrhoea
|
0.88%
1/113 • Number of events 1
|
0.00%
0/113
|
|
Infections and infestations
Viral infection
|
0.88%
1/113 • Number of events 1
|
0.00%
0/113
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.88%
1/113 • Number of events 2
|
0.00%
0/113
|
|
Injury, poisoning and procedural complications
Contusion
|
0.88%
1/113 • Number of events 1
|
0.88%
1/113 • Number of events 1
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.88%
1/113 • Number of events 1
|
0.00%
0/113
|
|
Injury, poisoning and procedural complications
facial bones fracture
|
0.88%
1/113 • Number of events 1
|
0.00%
0/113
|
|
Injury, poisoning and procedural complications
Injury corneal
|
0.88%
1/113 • Number of events 1
|
0.00%
0/113
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.88%
1/113 • Number of events 1
|
0.00%
0/113
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/113
|
0.88%
1/113 • Number of events 1
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.88%
1/113 • Number of events 1
|
0.00%
0/113
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.88%
1/113 • Number of events 1
|
0.00%
0/113
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/113
|
0.88%
1/113 • Number of events 1
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.88%
1/113 • Number of events 1
|
0.00%
0/113
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/113
|
0.88%
1/113 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/113
|
0.88%
1/113 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/113
|
0.88%
1/113 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.88%
1/113 • Number of events 1
|
4.4%
5/113 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Bone spur
|
0.00%
0/113
|
0.88%
1/113 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/113
|
1.8%
2/113 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/113
|
0.88%
1/113 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/113
|
0.88%
1/113 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.00%
0/113
|
0.88%
1/113 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/113
|
0.88%
1/113 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.88%
1/113 • Number of events 1
|
0.00%
0/113
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Polyp
|
0.88%
1/113 • Number of events 1
|
0.00%
0/113
|
|
Nervous system disorders
Burning sensation
|
0.88%
1/113 • Number of events 1
|
0.00%
0/113
|
|
Nervous system disorders
Disturbance in attention
|
0.88%
1/113 • Number of events 1
|
0.00%
0/113
|
|
Nervous system disorders
Dizziness
|
0.88%
1/113 • Number of events 1
|
0.00%
0/113
|
|
Nervous system disorders
Headache
|
0.88%
1/113 • Number of events 2
|
1.8%
2/113 • Number of events 2
|
|
Nervous system disorders
Oral dysaesthesia
|
2.7%
3/113 • Number of events 3
|
2.7%
3/113 • Number of events 3
|
|
Nervous system disorders
Paraesthesia oral
|
11.5%
13/113 • Number of events 17
|
5.3%
6/113 • Number of events 8
|
|
Psychiatric disorders
Insomnia
|
0.88%
1/113 • Number of events 1
|
0.00%
0/113
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/113
|
0.88%
1/113 • Number of events 1
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.88%
1/113 • Number of events 1
|
0.00%
0/113
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.00%
0/113
|
0.88%
1/113 • Number of events 1
|
|
Reproductive system and breast disorders
Menopausal symptoms
|
0.88%
1/113 • Number of events 1
|
0.00%
0/113
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/113
|
0.88%
1/113 • Number of events 1
|
|
Reproductive system and breast disorders
Uterine cyst
|
0.88%
1/113 • Number of events 1
|
0.00%
0/113
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
2.7%
3/113 • Number of events 4
|
4.4%
5/113 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Asthma exercise induced
|
0.88%
1/113 • Number of events 1
|
0.00%
0/113
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.4%
5/113 • Number of events 5
|
2.7%
3/113 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.5%
4/113 • Number of events 4
|
0.88%
1/113 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.88%
1/113 • Number of events 1
|
0.00%
0/113
|
|
Respiratory, thoracic and mediastinal disorders
Maxillary sinusitis
|
1.8%
2/113 • Number of events 2
|
0.00%
0/113
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/113
|
0.88%
1/113 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal mucosal disorder
|
0.88%
1/113 • Number of events 1
|
0.00%
0/113
|
|
Respiratory, thoracic and mediastinal disorders
Nasal passage irritation
|
4.4%
5/113 • Number of events 5
|
5.3%
6/113 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal swelling
|
0.88%
1/113 • Number of events 1
|
0.00%
0/113
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal oedema
|
0.00%
0/113
|
0.88%
1/113 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
1.8%
2/113 • Number of events 2
|
0.88%
1/113 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
5.3%
6/113 • Number of events 6
|
4.4%
5/113 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
1.8%
2/113 • Number of events 2
|
2.7%
3/113 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis seasonal
|
1.8%
2/113 • Number of events 2
|
0.00%
0/113
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
1.8%
2/113 • Number of events 2
|
0.88%
1/113 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
6.2%
7/113 • Number of events 7
|
1.8%
2/113 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
4.4%
5/113 • Number of events 7
|
3.5%
4/113 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Angioneurotic oedema
|
0.88%
1/113 • Number of events 2
|
0.00%
0/113
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.88%
1/113 • Number of events 1
|
0.00%
0/113
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.88%
1/113 • Number of events 1
|
0.00%
0/113
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.88%
1/113 • Number of events 1
|
0.88%
1/113 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/113
|
0.88%
1/113 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermatitis medicamentosa
|
0.88%
1/113 • Number of events 1
|
0.00%
0/113
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.88%
1/113 • Number of events 1
|
1.8%
2/113 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.88%
1/113 • Number of events 1
|
0.88%
1/113 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Exanthem
|
0.00%
0/113
|
0.88%
1/113 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Leukocytoclastic vasculitis
|
0.00%
0/113
|
0.88%
1/113 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Neurodermatitis
|
0.88%
1/113 • Number of events 1
|
0.00%
0/113
|
|
Skin and subcutaneous tissue disorders
Panniculitis
|
0.00%
0/113
|
0.88%
1/113 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.7%
3/113 • Number of events 3
|
0.88%
1/113 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
1.8%
2/113 • Number of events 3
|
0.00%
0/113
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/113
|
0.88%
1/113 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Urticaria papular
|
0.88%
1/113 • Number of events 1
|
0.00%
0/113
|
|
Surgical and medical procedures
Cholecystectomy
|
0.88%
1/113 • Number of events 1
|
0.00%
0/113
|
|
Surgical and medical procedures
Colon polypectomy
|
0.88%
1/113 • Number of events 1
|
0.00%
0/113
|
|
Surgical and medical procedures
Dental operation
|
0.88%
1/113 • Number of events 2
|
0.88%
1/113 • Number of events 1
|
|
Surgical and medical procedures
Joint surgery
|
0.00%
0/113
|
0.88%
1/113 • Number of events 1
|
|
Surgical and medical procedures
Lipoma excision
|
0.00%
0/113
|
0.88%
1/113 • Number of events 1
|
|
Surgical and medical procedures
Sinus operation
|
0.88%
1/113 • Number of events 1
|
0.00%
0/113
|
|
Surgical and medical procedures
Skin neoplasm excision
|
0.88%
1/113 • Number of events 1
|
0.00%
0/113
|
|
Surgical and medical procedures
Tonsillectomy
|
0.88%
1/113 • Number of events 1
|
0.00%
0/113
|
|
Surgical and medical procedures
Tooth extraction
|
0.88%
1/113 • Number of events 1
|
0.00%
0/113
|
|
Vascular disorders
Flushing
|
0.88%
1/113 • Number of events 1
|
0.00%
0/113
|
|
Vascular disorders
Thrombosis
|
0.00%
0/113
|
0.88%
1/113 • Number of events 1
|
Additional Information
Kim Simonsen, Senior Director
ALK-Abelló A/S
Phone: +4545747576
Results disclosure agreements
- Principal investigator is a sponsor employee ALK must receive copies of any intended communication in advance of publication (at least 15 working days for an abstract or oral presentation and 45 working days for a journal submission). ALK will review the communications for accuracy (thus avoiding potential discrepancies with submissions to health authorities), verify that confidential information is not being inadvertently divulged and provide any relevant supplementary information.
- Publication restrictions are in place
Restriction type: OTHER