Trial Outcomes & Findings for Study Evaluating Pantoprazole in Children With Gastroesophageal Reflux Disease (GERD) (NCT NCT00300755)
NCT ID: NCT00300755
Last Updated: 2010-05-19
Results Overview
WGSS is the sum of 5 selected individual weekly GERD mean frequency scores: vomiting/regurgitation, choking/gagging, refusal to eat, difficulty swallowing and abdominal/belly pain. Symptoms were assessed using a parent-administered questionnaire. The score for each individual symptom ranged from 0 (no symptoms) to 3 (highest frequency of symptoms), giving a WGSS range of 0-15. Change = score at week of assessment minus baseline score. Final week was defined as the last 7 days of symptom scores collected in the treatment period.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
60 participants
Primary outcome timeframe
Baseline and 8 weeks
Results posted on
2010-05-19
Participant Flow
Patients were recruited in the United States and Canada from May 2006 to February 2008.
Patients were screened for up to four weeks.
Participant milestones
| Measure |
Low Dose Pantoprazole (Approximately 0.3 mg/kg)
Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 5 mg once daily for 8 weeks
|
Medium Dose Pantoprazole (Approximately 0.6 mg/kg)
Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 10 mg once daily for 8 weeks
|
High Dose Pantoprazole (Approximately 1.2 mg/kg)
Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 15 mg once daily for 8 weeks for patients ≥1 to \<2 years. Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 20 mg once daily for 8 weeks for patients from ≥2 to \<6 years.
|
|---|---|---|---|
|
Overall Study
STARTED
|
18
|
21
|
21
|
|
Overall Study
COMPLETED
|
17
|
17
|
19
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
2
|
Reasons for withdrawal
| Measure |
Low Dose Pantoprazole (Approximately 0.3 mg/kg)
Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 5 mg once daily for 8 weeks
|
Medium Dose Pantoprazole (Approximately 0.6 mg/kg)
Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 10 mg once daily for 8 weeks
|
High Dose Pantoprazole (Approximately 1.2 mg/kg)
Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 15 mg once daily for 8 weeks for patients ≥1 to \<2 years. Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 20 mg once daily for 8 weeks for patients from ≥2 to \<6 years.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
Baseline Characteristics
Study Evaluating Pantoprazole in Children With Gastroesophageal Reflux Disease (GERD)
Baseline characteristics by cohort
| Measure |
Low Dose Pantoprazole (Approximately 0.3 mg/kg)
n=18 Participants
Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 5 mg once daily for 8 weeks
|
Medium Dose Pantoprazole (Approximately 0.6 mg/kg)
n=21 Participants
Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 10 mg once daily for 8 weeks
|
High Dose Pantoprazole (Approximately 1.2 mg/kg)
n=21 Participants
Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 15 mg once daily for 8 weeks for patients ≥1 to \<2 years. Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 20 mg once daily for 8 weeks for patients from ≥2 to \<6 years.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
2.67 years
STANDARD_DEVIATION 1.61 • n=99 Participants
|
1.90 years
STANDARD_DEVIATION 1.18 • n=107 Participants
|
2.76 years
STANDARD_DEVIATION 1.34 • n=206 Participants
|
2.43 years
STANDARD_DEVIATION 1.41 • n=7 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
23.0 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
37.0 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline and 8 weeksPopulation: The primary efficacy population (mITT NERD) included all patients who were randomized and received ≥1 dose of test article and had nonerosive gastroesophageal reflux disease. Last observation carried forward (except for baseline data, which were not carried forward into the treatment period).
WGSS is the sum of 5 selected individual weekly GERD mean frequency scores: vomiting/regurgitation, choking/gagging, refusal to eat, difficulty swallowing and abdominal/belly pain. Symptoms were assessed using a parent-administered questionnaire. The score for each individual symptom ranged from 0 (no symptoms) to 3 (highest frequency of symptoms), giving a WGSS range of 0-15. Change = score at week of assessment minus baseline score. Final week was defined as the last 7 days of symptom scores collected in the treatment period.
Outcome measures
| Measure |
Low Dose Pantoprazole (Approximately 0.3 mg/kg)
n=18 Participants
Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 5 mg once daily for 8 weeks
|
Medium Dose Pantoprazole (Approximately 0.6 mg/kg)
n=19 Participants
Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 10 mg once daily for 8 weeks
|
High Dose Pantoprazole (Approximately 1.2 mg/kg)
n=19 Participants
Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 15 mg once daily for 8 weeks for patients ≥1 to \<2 years. Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 20 mg once daily for 8 weeks for patients from ≥2 to \<6 years.
|
|---|---|---|---|
|
Change in Weekly Gastroesophageal Reflux Disease (GERD) Symptom Scores (WGSS)
Week 1 Change from Baseline
|
-0.89 units on scale
Standard Deviation 1.41
|
0.02 units on scale
Standard Deviation 0.99
|
-0.47 units on scale
Standard Deviation 1.25
|
|
Change in Weekly Gastroesophageal Reflux Disease (GERD) Symptom Scores (WGSS)
Week 2 Change from Baseline
|
-1.11 units on scale
Standard Deviation 1.29
|
-0.11 units on scale
Standard Deviation 1.06
|
-1.24 units on scale
Standard Deviation 1.42
|
|
Change in Weekly Gastroesophageal Reflux Disease (GERD) Symptom Scores (WGSS)
Week 3 Change from Baseline
|
-1.31 units on scale
Standard Deviation 1.43
|
-0.16 units on scale
Standard Deviation 1.23
|
-1.38 units on scale
Standard Deviation 1.47
|
|
Change in Weekly Gastroesophageal Reflux Disease (GERD) Symptom Scores (WGSS)
Week 4 Change from Baseline
|
-1.84 units on scale
Standard Deviation 1.95
|
-0.20 units on scale
Standard Deviation 1.29
|
-1.32 units on scale
Standard Deviation 1.36
|
|
Change in Weekly Gastroesophageal Reflux Disease (GERD) Symptom Scores (WGSS)
Week 5 Change from Baseline
|
-2.05 units on scale
Standard Deviation 2.08
|
-0.48 units on scale
Standard Deviation 1.31
|
-1.30 units on scale
Standard Deviation 1.63
|
|
Change in Weekly Gastroesophageal Reflux Disease (GERD) Symptom Scores (WGSS)
Week 6 Change from Baseline
|
-1.99 units on scale
Standard Deviation 1.83
|
-0.61 units on scale
Standard Deviation 1.31
|
-1.42 units on scale
Standard Deviation 1.59
|
|
Change in Weekly Gastroesophageal Reflux Disease (GERD) Symptom Scores (WGSS)
Week 7 Change from Baseline
|
-2.44 units on scale
Standard Deviation 1.75
|
-0.58 units on scale
Standard Deviation 1.38
|
-1.58 units on scale
Standard Deviation 1.62
|
|
Change in Weekly Gastroesophageal Reflux Disease (GERD) Symptom Scores (WGSS)
Week 8 Change from Baseline
|
-2.34 units on scale
Standard Deviation 1.81
|
-0.60 units on scale
Standard Deviation 1.49
|
-1.61 units on scale
Standard Deviation 1.61
|
|
Change in Weekly Gastroesophageal Reflux Disease (GERD) Symptom Scores (WGSS)
Final Week Change from Baseline
|
-2.37 units on scale
Standard Deviation 1.74
|
-0.64 units on scale
Standard Deviation 1.40
|
-1.66 units on scale
Standard Deviation 1.64
|
SECONDARY outcome
Timeframe: Baseline and 8 weeksPopulation: The analysis population is all patients who were randomized and received ≥1 dose of test article and had nonerosive gastroesophageal reflux disease.
Selected symptoms of GERD were assessed using a parent-administered questionnaire. The score for each symptom ranged from 0 (no symptom) to 3 (highest frequency of symptom), The weekly mean score was the sum of daily scores that week, divided by the number of days with scores for that week. Change = final week score minus baseline score. Final week was defined as the last 7 days of scores collected in the treatment period.
Outcome measures
| Measure |
Low Dose Pantoprazole (Approximately 0.3 mg/kg)
n=18 Participants
Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 5 mg once daily for 8 weeks
|
Medium Dose Pantoprazole (Approximately 0.6 mg/kg)
n=19 Participants
Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 10 mg once daily for 8 weeks
|
High Dose Pantoprazole (Approximately 1.2 mg/kg)
n=19 Participants
Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 15 mg once daily for 8 weeks for patients ≥1 to \<2 years. Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 20 mg once daily for 8 weeks for patients from ≥2 to \<6 years.
|
|---|---|---|---|
|
Change in Individual Weekly Mean Frequency Score for Each Gastroesophageal Reflux Disease (GERD) Symptom Score From Baseline to Final Week
Vomiting/regurgitation
|
-0.77 units on scale
Standard Deviation 0.89
|
-0.06 units on scale
Standard Deviation 0.28
|
-0.25 units on scale
Standard Deviation 0.48
|
|
Change in Individual Weekly Mean Frequency Score for Each Gastroesophageal Reflux Disease (GERD) Symptom Score From Baseline to Final Week
Choking/gagging
|
-0.43 units on scale
Standard Deviation 0.33
|
-0.05 units on scale
Standard Deviation 0.48
|
-0.47 units on scale
Standard Deviation 0.59
|
|
Change in Individual Weekly Mean Frequency Score for Each Gastroesophageal Reflux Disease (GERD) Symptom Score From Baseline to Final Week
Refusal to eat
|
-0.34 units on scale
Standard Deviation 0.49
|
-0.16 units on scale
Standard Deviation 0.61
|
-0.26 units on scale
Standard Deviation 0.69
|
|
Change in Individual Weekly Mean Frequency Score for Each Gastroesophageal Reflux Disease (GERD) Symptom Score From Baseline to Final Week
Difficulty swallowing
|
-0.42 units on scale
Standard Deviation 0.52
|
-0.13 units on scale
Standard Deviation 0.49
|
-0.39 units on scale
Standard Deviation 0.79
|
|
Change in Individual Weekly Mean Frequency Score for Each Gastroesophageal Reflux Disease (GERD) Symptom Score From Baseline to Final Week
Abdominal/belly pain
|
-0.42 units on scale
Standard Deviation 0.49
|
-0.24 units on scale
Standard Deviation 0.44
|
-0.28 units on scale
Standard Deviation 0.49
|
SECONDARY outcome
Timeframe: Baseline and 8 weeksPopulation: The analysis population is all patients who were randomized and received ≥1 dose of test article and had nonerosive gastroesophageal reflux disease. Data were excluded if a patient answered a question \<3 times in a week.
Individual respiratory symptoms weekly score was calculated as the average score / number of events for a patient in the corresponding week if the patient answered a question ≥3 times that week. Change = final week score minus baseline score. Final week was defined as the last 7 days of scores collected in the treatment period.
Outcome measures
| Measure |
Low Dose Pantoprazole (Approximately 0.3 mg/kg)
n=18 Participants
Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 5 mg once daily for 8 weeks
|
Medium Dose Pantoprazole (Approximately 0.6 mg/kg)
n=19 Participants
Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 10 mg once daily for 8 weeks
|
High Dose Pantoprazole (Approximately 1.2 mg/kg)
n=19 Participants
Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 15 mg once daily for 8 weeks for patients ≥1 to \<2 years. Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 20 mg once daily for 8 weeks for patients from ≥2 to \<6 years.
|
|---|---|---|---|
|
Change in Individual Weekly Mean Score For Each Respiratory Symptom From Baseline
Presence of cold or fever: scale 1=yes 0=no
|
0.11 units on scale
Standard Deviation 0.41
|
0.13 units on scale
Standard Deviation 0.43
|
0.11 units on scale
Standard Deviation 0.52
|
|
Change in Individual Weekly Mean Score For Each Respiratory Symptom From Baseline
Cough without cold: scale 1=yes 0=no
|
-0.38 units on scale
Standard Deviation 0.34
|
-0.20 units on scale
Standard Deviation 0.38
|
-0.24 units on scale
Standard Deviation 0.36
|
|
Change in Individual Weekly Mean Score For Each Respiratory Symptom From Baseline
Noisy breathing: scale 0(none)-3(most of the time)
|
-0.48 units on scale
Standard Deviation 0.97
|
-0.19 units on scale
Standard Deviation 0.35
|
-0.16 units on scale
Standard Deviation 0.36
|
|
Change in Individual Weekly Mean Score For Each Respiratory Symptom From Baseline
Noisy breathing on exhale: scale 1=yes 0=no
|
-0.11 units on scale
Standard Deviation 0.55
|
-0.15 units on scale
Standard Deviation 0.29
|
-0.16 units on scale
Standard Deviation 0.29
|
|
Change in Individual Weekly Mean Score For Each Respiratory Symptom From Baseline
Wheezing or whistling sound: scale 1=yes 0=no
|
-0.15 units on scale
Standard Deviation 0.46
|
-0.04 units on scale
Standard Deviation 0.12
|
-0.02 units on scale
Standard Deviation 0.08
|
|
Change in Individual Weekly Mean Score For Each Respiratory Symptom From Baseline
Noisy breathing on inhale: scale 1=yes 0=no
|
-0.11 units on scale
Standard Deviation 0.49
|
-0.16 units on scale
Standard Deviation 0.30
|
-0.16 units on scale
Standard Deviation 0.31
|
|
Change in Individual Weekly Mean Score For Each Respiratory Symptom From Baseline
Croupy or barky sound: scale 1=yes 0=no
|
-0.09 units on scale
Standard Deviation 0.30
|
-0.03 units on scale
Standard Deviation 0.11
|
-0.13 units on scale
Standard Deviation 0.32
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: The analysis population is randomized patients with erosive esophagitis at baseline.
Healed EE was defined as a modified Hetzel-Dent (HD) score \<2 on endoscopy at end of study. HD is a standardized rating scale for grading esophageal damage and severity of gastroesophageal reflux disease (GERD). HD score ranges from 0 (normal mucosa) to 4 (deep peptic ulceration).
Outcome measures
| Measure |
Low Dose Pantoprazole (Approximately 0.3 mg/kg)
Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 5 mg once daily for 8 weeks
|
Medium Dose Pantoprazole (Approximately 0.6 mg/kg)
n=2 Participants
Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 10 mg once daily for 8 weeks
|
High Dose Pantoprazole (Approximately 1.2 mg/kg)
n=2 Participants
Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 15 mg once daily for 8 weeks for patients ≥1 to \<2 years. Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 20 mg once daily for 8 weeks for patients from ≥2 to \<6 years.
|
|---|---|---|---|
|
Number of Patients With "Healed" Erosive Esophagitis (EE) at End of Study
|
0 patients
|
2 patients
|
2 patients
|
Adverse Events
Low Dose Pantoprazole (Approximately 0.3 mg/kg)
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Medium Dose Pantoprazole (Approximately 0.6 mg/kg)
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
High Dose Pantoprazole (Approximately 1.2 mg/kg)
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Low Dose Pantoprazole (Approximately 0.3 mg/kg)
Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 5 mg once daily for 8 weeks
|
Medium Dose Pantoprazole (Approximately 0.6 mg/kg)
Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 10 mg once daily for 8 weeks
|
High Dose Pantoprazole (Approximately 1.2 mg/kg)
Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 15 mg once daily for 8 weeks for patients ≥1 to \<2 years. Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 20 mg once daily for 8 weeks for patients from ≥2 to \<6 years.
|
|---|---|---|---|
|
General disorders
Abdominal pain
|
0.00%
0/18
|
4.8%
1/21
|
0.00%
0/21
|
|
Gastrointestinal disorders
Anorexia
|
0.00%
0/18
|
0.00%
0/21
|
4.8%
1/21
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/18
|
0.00%
0/21
|
4.8%
1/21
|
Other adverse events
| Measure |
Low Dose Pantoprazole (Approximately 0.3 mg/kg)
Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 5 mg once daily for 8 weeks
|
Medium Dose Pantoprazole (Approximately 0.6 mg/kg)
Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 10 mg once daily for 8 weeks
|
High Dose Pantoprazole (Approximately 1.2 mg/kg)
Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 15 mg once daily for 8 weeks for patients ≥1 to \<2 years. Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 20 mg once daily for 8 weeks for patients from ≥2 to \<6 years.
|
|---|---|---|---|
|
General disorders
Abdominal pain
|
5.6%
1/18
|
4.8%
1/21
|
14.3%
3/21
|
|
General disorders
Accidental injury
|
16.7%
3/18
|
14.3%
3/21
|
9.5%
2/21
|
|
General disorders
Fever
|
11.1%
2/18
|
23.8%
5/21
|
19.0%
4/21
|
|
General disorders
Flu syndrome
|
0.00%
0/18
|
4.8%
1/21
|
4.8%
1/21
|
|
General disorders
Headache
|
16.7%
3/18
|
4.8%
1/21
|
19.0%
4/21
|
|
General disorders
Infection
|
5.6%
1/18
|
0.00%
0/21
|
4.8%
1/21
|
|
General disorders
Injection site hypersensitivity
|
0.00%
0/18
|
4.8%
1/21
|
0.00%
0/21
|
|
General disorders
Lab test abnormal
|
0.00%
0/18
|
0.00%
0/21
|
4.8%
1/21
|
|
General disorders
Pain
|
5.6%
1/18
|
0.00%
0/21
|
0.00%
0/21
|
|
Cardiac disorders
Hemorrhage
|
5.6%
1/18
|
0.00%
0/21
|
0.00%
0/21
|
|
Gastrointestinal disorders
Anorexia
|
0.00%
0/18
|
0.00%
0/21
|
4.8%
1/21
|
|
Gastrointestinal disorders
Constipation
|
5.6%
1/18
|
0.00%
0/21
|
4.8%
1/21
|
|
Gastrointestinal disorders
Diarrhea
|
22.2%
4/18
|
9.5%
2/21
|
14.3%
3/21
|
|
Gastrointestinal disorders
Gastroenteritis
|
5.6%
1/18
|
4.8%
1/21
|
9.5%
2/21
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/18
|
0.00%
0/21
|
4.8%
1/21
|
|
Gastrointestinal disorders
Gingivitis
|
0.00%
0/18
|
0.00%
0/21
|
4.8%
1/21
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/18
|
0.00%
0/21
|
4.8%
1/21
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/18
|
0.00%
0/21
|
4.8%
1/21
|
|
Gastrointestinal disorders
Tooth cavities
|
5.6%
1/18
|
0.00%
0/21
|
0.00%
0/21
|
|
Gastrointestinal disorders
Tooth disorder
|
5.6%
1/18
|
4.8%
1/21
|
0.00%
0/21
|
|
Gastrointestinal disorders
Vomiting
|
11.1%
2/18
|
19.0%
4/21
|
14.3%
3/21
|
|
Blood and lymphatic system disorders
Ecchymosis
|
11.1%
2/18
|
4.8%
1/21
|
4.8%
1/21
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
5.6%
1/18
|
4.8%
1/21
|
14.3%
3/21
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/18
|
4.8%
1/21
|
4.8%
1/21
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/18
|
4.8%
1/21
|
0.00%
0/21
|
|
Blood and lymphatic system disorders
Hyperlipemia
|
0.00%
0/18
|
0.00%
0/21
|
4.8%
1/21
|
|
Metabolism and nutrition disorders
Peripheral edema
|
5.6%
1/18
|
0.00%
0/21
|
4.8%
1/21
|
|
Nervous system disorders
Ataxia
|
0.00%
0/18
|
0.00%
0/21
|
4.8%
1/21
|
|
Nervous system disorders
Hyperkinesia
|
0.00%
0/18
|
0.00%
0/21
|
4.8%
1/21
|
|
Nervous system disorders
Sleep disorder
|
0.00%
0/18
|
4.8%
1/21
|
0.00%
0/21
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/18
|
0.00%
0/21
|
4.8%
1/21
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.00%
0/18
|
0.00%
0/21
|
4.8%
1/21
|
|
Respiratory, thoracic and mediastinal disorders
Cough increased
|
16.7%
3/18
|
14.3%
3/21
|
4.8%
1/21
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/18
|
4.8%
1/21
|
4.8%
1/21
|
|
Respiratory, thoracic and mediastinal disorders
Laryngitis
|
0.00%
0/18
|
4.8%
1/21
|
4.8%
1/21
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis
|
16.7%
3/18
|
9.5%
2/21
|
0.00%
0/21
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
16.7%
3/18
|
4.8%
1/21
|
23.8%
5/21
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
5.6%
1/18
|
0.00%
0/21
|
9.5%
2/21
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
44.4%
8/18
|
33.3%
7/21
|
38.1%
8/21
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
5.6%
1/18
|
0.00%
0/21
|
0.00%
0/21
|
|
Skin and subcutaneous tissue disorders
Contact dermatitis
|
0.00%
0/18
|
4.8%
1/21
|
4.8%
1/21
|
|
Skin and subcutaneous tissue disorders
Exfoliative dermatitis
|
0.00%
0/18
|
0.00%
0/21
|
4.8%
1/21
|
|
Skin and subcutaneous tissue disorders
Maculopapular rash
|
0.00%
0/18
|
0.00%
0/21
|
4.8%
1/21
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.6%
1/18
|
4.8%
1/21
|
0.00%
0/21
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/18
|
4.8%
1/21
|
0.00%
0/21
|
|
Ear and labyrinth disorders
Ear pain
|
5.6%
1/18
|
0.00%
0/21
|
0.00%
0/21
|
|
Eye disorders
Eye pain
|
5.6%
1/18
|
0.00%
0/21
|
0.00%
0/21
|
|
Ear and labyrinth disorders
Otitis media
|
5.6%
1/18
|
0.00%
0/21
|
4.8%
1/21
|
|
Renal and urinary disorders
Urinary tract infection
|
0.00%
0/18
|
0.00%
0/21
|
4.8%
1/21
|
|
Reproductive system and breast disorders
Vulvovaginal disorder
|
5.6%
1/18
|
0.00%
0/21
|
0.00%
0/21
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The PIs agreed to allow the sponsor 60 days to review and require changes to presentations or publications but only to protect confidential information and intellectual property, and for the sponsor to file a patent application, as applicable. The PIs also agreed for data to be presented first as a joint, multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER