Trial Outcomes & Findings for A Study of the Safety and Effectiveness of Rabeprazole for the Treatment of Gastroesophageal Reflux Disease (GERD) in Pediatric Patients (NCT NCT00787891)
NCT ID: NCT00787891
Last Updated: 2013-01-24
Results Overview
Healing is defined as macroscopically normal esophageal mucosa or histologic normal esophageal mucosa.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
127 participants
Primary outcome timeframe
12 weeks
Results posted on
2013-01-24
Participant Flow
In this study, 108 patients completed the 12-week phase (Part 1) and were counted for the primary outcome measure (OM). Patients with healing at Week 12 had the option to continue the treatment for 24 weeks. Among the 87 with healing, 64 enrolled into Part 2. Only 52 had the primary efficacy endpoint available and were included in the primary OM.
Participant milestones
| Measure |
Rabeprazole 0.5 mg/kg
Pediatric micro-bead formulation of rabeprazole sodium orally administered.
|
Rabeprazole 1.0 mg/kg
Pediatric micro-bead formulation of rabeprazole sodium orally administered.
|
|---|---|---|
|
Short-term Double-blind Phase (Part 1)
STARTED
|
65
|
62
|
|
Short-term Double-blind Phase (Part 1)
COMPLETED
|
55
|
53
|
|
Short-term Double-blind Phase (Part 1)
NOT COMPLETED
|
10
|
9
|
|
Maintenance Double-blind Phase (Part 2)
STARTED
|
33
|
31
|
|
Maintenance Double-blind Phase (Part 2)
COMPLETED
|
26
|
24
|
|
Maintenance Double-blind Phase (Part 2)
NOT COMPLETED
|
7
|
7
|
Reasons for withdrawal
| Measure |
Rabeprazole 0.5 mg/kg
Pediatric micro-bead formulation of rabeprazole sodium orally administered.
|
Rabeprazole 1.0 mg/kg
Pediatric micro-bead formulation of rabeprazole sodium orally administered.
|
|---|---|---|
|
Short-term Double-blind Phase (Part 1)
Adverse Event
|
1
|
2
|
|
Short-term Double-blind Phase (Part 1)
Lost to Follow-up
|
2
|
2
|
|
Short-term Double-blind Phase (Part 1)
Protocol Violation
|
0
|
1
|
|
Short-term Double-blind Phase (Part 1)
Physician Decision
|
1
|
0
|
|
Short-term Double-blind Phase (Part 1)
Withdrawal by Subject
|
6
|
2
|
|
Short-term Double-blind Phase (Part 1)
Other
|
0
|
2
|
|
Maintenance Double-blind Phase (Part 2)
Adverse Event
|
0
|
1
|
|
Maintenance Double-blind Phase (Part 2)
Non-Compliance With Study Drug
|
1
|
1
|
|
Maintenance Double-blind Phase (Part 2)
Withdrawal by Subject
|
1
|
3
|
|
Maintenance Double-blind Phase (Part 2)
Other
|
5
|
2
|
Baseline Characteristics
A Study of the Safety and Effectiveness of Rabeprazole for the Treatment of Gastroesophageal Reflux Disease (GERD) in Pediatric Patients
Baseline characteristics by cohort
| Measure |
Rabeprazole 0.5 mg/kg
n=65 Participants
Pediatric micro-bead formulation of rabeprazole sodium orally administered.
|
Rabeprazole 1.0 mg/kg
n=62 Participants
Pediatric micro-bead formulation of rabeprazole sodium orally administered.
|
Total
n=127 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
65 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
127 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
5.9 years
STANDARD_DEVIATION 3.49 • n=5 Participants
|
5.4 years
STANDARD_DEVIATION 3.26 • n=7 Participants
|
5.7 years
STANDARD_DEVIATION 3.37 • n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Baseline BMI
|
17.5 kg/cm2
STANDARD_DEVIATION 4.08 • n=5 Participants
|
16.8 kg/cm2
STANDARD_DEVIATION 3.11 • n=7 Participants
|
17.2 kg/cm2
STANDARD_DEVIATION 3.64 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Intention to Treat (ITT) analysis set
Healing is defined as macroscopically normal esophageal mucosa or histologic normal esophageal mucosa.
Outcome measures
| Measure |
Rabeprazole Sodium 0.5 mg/kg
n=55 Participants
Pediatric micro-bead formulation of rabeprazole sodium orally administered.
|
Rabeprazole Sodium 1.0 mg/kg
n=53 Participants
Pediatric micro-bead formulation of rabeprazole sodium orally administered.
|
|---|---|---|
|
The Percentage of Patients With Healing by Week 12 (Short-term Double-blind Treatment Phase)
|
78 Percentage of participants
Interval 67.0 to 89.0
|
83 Percentage of participants
Interval 73.0 to 93.0
|
PRIMARY outcome
Timeframe: 36 weeksPopulation: Intention to Treat (ITT) analysis set
Healing is defined as macroscopically normal esophageal mucosa or histologic normal esophageal mucosa.
Outcome measures
| Measure |
Rabeprazole Sodium 0.5 mg/kg
n=26 Participants
Pediatric micro-bead formulation of rabeprazole sodium orally administered.
|
Rabeprazole Sodium 1.0 mg/kg
n=26 Participants
Pediatric micro-bead formulation of rabeprazole sodium orally administered.
|
|---|---|---|
|
The Percentage of Patients With Healing by Week 36 (Double-blind Maintenance Treatment Phase)
|
92 Percentage of patients
Interval 82.0 to 100.0
|
88 Percentage of patients
Interval 76.0 to 100.0
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Intention to Treat (ITT) analysis set
The Hetzel and Dent Classification grades range from 0 (normal esophageal mucosa, no abnormalities noted) to 4 (deep ulcers anywhere in the esophagus or ulceration of more than half of the esophageal mucosa). Higher observed scores indicate more serious condition. For change of baseline, a score of 0 indicates no change; a positive score indicates the condition is worsening, while a negative score indicates an improvement.
Outcome measures
| Measure |
Rabeprazole Sodium 0.5 mg/kg
n=55 Participants
Pediatric micro-bead formulation of rabeprazole sodium orally administered.
|
Rabeprazole Sodium 1.0 mg/kg
n=53 Participants
Pediatric micro-bead formulation of rabeprazole sodium orally administered.
|
|---|---|---|
|
The Change From Baseline in the Hetzel and Dent Endoscopic Classification Grade Score (Short-term Double-blind Treatment Phase)
|
-1.3 Scores on a scale
Standard Deviation 0.85
|
-1.0 Scores on a scale
Standard Deviation 0.81
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Intention to Treat (ITT) analysis set
The gastroesophageal reflux disease (GERD) symptom and severity scale measures the frequency (0= Never; 1= 1-2 times; 2= 3-4 times; 3= 5-6 times; 4= 7 or more times) and the severity (1= Mild; 2= Moderate; 3=Severe) of GERD symptoms. The score is defined as the sum of the frequency (0-4) and severity (1-3) of that symptom. The total score is the sum of the scores of all the symptoms and ranges from 12 to 84. Higher scores indicate more serious condition. For change from baseline, 0 indicates no change; a positive score indicates worsening, while a negative score indicates improvement.
Outcome measures
| Measure |
Rabeprazole Sodium 0.5 mg/kg
n=61 Participants
Pediatric micro-bead formulation of rabeprazole sodium orally administered.
|
Rabeprazole Sodium 1.0 mg/kg
n=59 Participants
Pediatric micro-bead formulation of rabeprazole sodium orally administered.
|
|---|---|---|
|
The Change From Baseline in the Total GERD Symptom and Severity Score (Short-term Double-blind Treatment Phase)
|
-11.5 Scores on a scale
Standard Deviation 11.70
|
-8.5 Scores on a scale
Standard Deviation 9.75
|
SECONDARY outcome
Timeframe: Baseline, Week 36Population: Intention to Treat (ITT) analysis set
The Hetzel and Dent Classification grades range from 0 (normal esophageal mucosa, no abnormalities noted) to 4 (deep ulcers anywhere in the esophagus or ulceration of more than half of the esophageal mucosa). Higher observed scores indicate more serious condition. For change of baseline, a score of 0 indicates no change; a positive score indicates the condition is worsening, while a negative score indicates an improvement.
Outcome measures
| Measure |
Rabeprazole Sodium 0.5 mg/kg
n=26 Participants
Pediatric micro-bead formulation of rabeprazole sodium orally administered.
|
Rabeprazole Sodium 1.0 mg/kg
n=26 Participants
Pediatric micro-bead formulation of rabeprazole sodium orally administered.
|
|---|---|---|
|
The Change From Baseline in the Hetzel and Dent Endoscopic Classification Grade Score (Double-blind Maintenance Treatment Phase)
|
0.2 Scores on a scale
Standard Deviation 0.49
|
0.2 Scores on a scale
Standard Deviation 0.54
|
SECONDARY outcome
Timeframe: Baseline, Week 36Population: Intention to Treat (ITT) analysis set
The gastroesophageal reflux disease (GERD) symptom and severity scale measures the frequency (0= Never; 1= 1-2 times; 2= 3-4 times; 3= 5-6 times; 4= 7 or more times) and the severity (1= Mild; 2= Moderate; 3=Severe) of GERD symptoms. The score is defined as the sum of the frequency (0-4) and severity (1-3) of that symptom. The total score is the sum of the scores of all the symptoms and ranges from 12 to 84. Higher scores indicate more serious condition. For change from baseline, 0 indicates no change; a positive score indicates worsening, while a negative score indicates improvement.
Outcome measures
| Measure |
Rabeprazole Sodium 0.5 mg/kg
n=32 Participants
Pediatric micro-bead formulation of rabeprazole sodium orally administered.
|
Rabeprazole Sodium 1.0 mg/kg
n=29 Participants
Pediatric micro-bead formulation of rabeprazole sodium orally administered.
|
|---|---|---|
|
The Change From Baseline in the Total GERD Symptom and Severity Score (Double-blind Maintenance Treatment Phase)
|
-2.9 Scores on a scale
Standard Deviation 4.82
|
-1.4 Scores on a scale
Standard Deviation 9.59
|
Adverse Events
Rabeprazole 0.5 mg/kg (Short-term Double-blinde Phase)
Serious events: 5 serious events
Other events: 47 other events
Deaths: 0 deaths
Rabeprazole 1.0 mg/kg (Short-term Double-blinde Phase)
Serious events: 1 serious events
Other events: 47 other events
Deaths: 0 deaths
Rabeprazole 0.5 mg/kg (Double-blind Maintenance Phase)
Serious events: 2 serious events
Other events: 18 other events
Deaths: 0 deaths
Rabeprazole 1.0 mg/kg (Double-blind Maintenance Phase
Serious events: 3 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rabeprazole 0.5 mg/kg (Short-term Double-blinde Phase)
n=65 participants at risk
Pediatric micro-bead formulation of rabeprazole sodium orally administered.
|
Rabeprazole 1.0 mg/kg (Short-term Double-blinde Phase)
n=62 participants at risk
Pediatric micro-bead formulation of rabeprazole sodium orally administered.
|
Rabeprazole 0.5 mg/kg (Double-blind Maintenance Phase)
n=33 participants at risk
Pediatric micro-bead formulation of rabeprazole sodium orally administered.
|
Rabeprazole 1.0 mg/kg (Double-blind Maintenance Phase
n=31 participants at risk
Pediatric micro-bead formulation of rabeprazole sodium orally administered.
|
|---|---|---|---|---|
|
Infections and infestations
Bronchopneumonia
|
1.5%
1/65
|
0.00%
0/62
|
0.00%
0/33
|
3.2%
1/31
|
|
Infections and infestations
Bronchitis
|
1.5%
1/65
|
0.00%
0/62
|
0.00%
0/33
|
0.00%
0/31
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/65
|
1.6%
1/62
|
0.00%
0/33
|
0.00%
0/31
|
|
Infections and infestations
Gastrointestinal Infection
|
1.5%
1/65
|
0.00%
0/62
|
0.00%
0/33
|
0.00%
0/31
|
|
Infections and infestations
Pneumonia
|
1.5%
1/65
|
0.00%
0/62
|
0.00%
0/33
|
0.00%
0/31
|
|
Injury, poisoning and procedural complications
Humerus Fracture
|
1.5%
1/65
|
0.00%
0/62
|
0.00%
0/33
|
0.00%
0/31
|
|
Metabolism and nutrition disorders
Dehydration
|
1.5%
1/65
|
0.00%
0/62
|
0.00%
0/33
|
0.00%
0/31
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/65
|
0.00%
0/62
|
0.00%
0/33
|
3.2%
1/31
|
|
Injury, poisoning and procedural complications
Head Injury
|
0.00%
0/65
|
0.00%
0/62
|
3.0%
1/33
|
0.00%
0/31
|
|
Nervous system disorders
Partial Seizures with Secondary Generalisation
|
0.00%
0/65
|
0.00%
0/62
|
3.0%
1/33
|
0.00%
0/31
|
|
Psychiatric disorders
Conversion Disorder
|
0.00%
0/65
|
0.00%
0/62
|
0.00%
0/33
|
3.2%
1/31
|
Other adverse events
| Measure |
Rabeprazole 0.5 mg/kg (Short-term Double-blinde Phase)
n=65 participants at risk
Pediatric micro-bead formulation of rabeprazole sodium orally administered.
|
Rabeprazole 1.0 mg/kg (Short-term Double-blinde Phase)
n=62 participants at risk
Pediatric micro-bead formulation of rabeprazole sodium orally administered.
|
Rabeprazole 0.5 mg/kg (Double-blind Maintenance Phase)
n=33 participants at risk
Pediatric micro-bead formulation of rabeprazole sodium orally administered.
|
Rabeprazole 1.0 mg/kg (Double-blind Maintenance Phase
n=31 participants at risk
Pediatric micro-bead formulation of rabeprazole sodium orally administered.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
10.8%
7/65
|
12.9%
8/62
|
9.1%
3/33
|
6.5%
2/31
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/65
|
1.6%
1/62
|
3.0%
1/33
|
3.2%
1/31
|
|
Gastrointestinal disorders
Diarrhoea
|
10.8%
7/65
|
11.3%
7/62
|
3.0%
1/33
|
9.7%
3/31
|
|
Gastrointestinal disorders
Dyspepsia
|
1.5%
1/65
|
1.6%
1/62
|
0.00%
0/33
|
6.5%
2/31
|
|
Gastrointestinal disorders
Vomiting
|
12.3%
8/65
|
16.1%
10/62
|
12.1%
4/33
|
9.7%
3/31
|
|
General disorders
Pyrexia
|
12.3%
8/65
|
8.1%
5/62
|
0.00%
0/33
|
9.7%
3/31
|
|
Infections and infestations
Bronchitis
|
1.5%
1/65
|
3.2%
2/62
|
3.0%
1/33
|
0.00%
0/31
|
|
Infections and infestations
Croup Infectious
|
1.5%
1/65
|
0.00%
0/62
|
3.0%
1/33
|
0.00%
0/31
|
|
Infections and infestations
Ear Infection
|
0.00%
0/65
|
3.2%
2/62
|
3.0%
1/33
|
0.00%
0/31
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/65
|
1.6%
1/62
|
3.0%
1/33
|
0.00%
0/31
|
|
Infections and infestations
Localised Infection
|
0.00%
0/65
|
1.6%
1/62
|
3.0%
1/33
|
0.00%
0/31
|
|
Infections and infestations
Nasopharyngitis
|
4.6%
3/65
|
4.8%
3/62
|
6.1%
2/33
|
3.2%
1/31
|
|
Infections and infestations
Otitis Media
|
4.6%
3/65
|
0.00%
0/62
|
6.1%
2/33
|
0.00%
0/31
|
|
Infections and infestations
Pharyngitis
|
4.6%
3/65
|
1.6%
1/62
|
3.0%
1/33
|
3.2%
1/31
|
|
Infections and infestations
Pharyngitis Streptococcal
|
1.5%
1/65
|
1.6%
1/62
|
6.1%
2/33
|
3.2%
1/31
|
|
Infections and infestations
Rhinitis
|
4.6%
3/65
|
1.6%
1/62
|
6.1%
2/33
|
0.00%
0/31
|
|
Infections and infestations
Sinusitis
|
3.1%
2/65
|
4.8%
3/62
|
6.1%
2/33
|
3.2%
1/31
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
9.2%
6/65
|
6.5%
4/62
|
12.1%
4/33
|
12.9%
4/31
|
|
Infections and infestations
Viral Infection
|
1.5%
1/65
|
3.2%
2/62
|
3.0%
1/33
|
3.2%
1/31
|
|
Injury, poisoning and procedural complications
Excoriation
|
1.5%
1/65
|
0.00%
0/62
|
0.00%
0/33
|
3.2%
1/31
|
|
Injury, poisoning and procedural complications
Fall
|
3.1%
2/65
|
0.00%
0/62
|
0.00%
0/33
|
3.2%
1/31
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/65
|
1.6%
1/62
|
0.00%
0/33
|
3.2%
1/31
|
|
Nervous system disorders
Headache
|
6.2%
4/65
|
11.3%
7/62
|
3.0%
1/33
|
0.00%
0/31
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/65
|
1.6%
1/62
|
0.00%
0/33
|
3.2%
1/31
|
|
Psychiatric disorders
Sleep Disorder
|
0.00%
0/65
|
1.6%
1/62
|
3.0%
1/33
|
0.00%
0/31
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.8%
9/65
|
14.5%
9/62
|
6.1%
2/33
|
0.00%
0/31
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.5%
1/65
|
0.00%
0/62
|
3.0%
1/33
|
0.00%
0/31
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
3.1%
2/65
|
9.7%
6/62
|
0.00%
0/33
|
6.5%
2/31
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/65
|
1.6%
1/62
|
3.0%
1/33
|
0.00%
0/31
|
|
Blood and lymphatic system disorders
Anaemia
|
1.5%
1/65
|
0.00%
0/62
|
0.00%
0/33
|
0.00%
0/31
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
1.5%
1/65
|
1.6%
1/62
|
0.00%
0/33
|
0.00%
0/31
|
|
Ear and labyrinth disorders
Ear Pain
|
0.00%
0/65
|
4.8%
3/62
|
0.00%
0/33
|
0.00%
0/31
|
|
Ear and labyrinth disorders
Eustachian Tube Obstruction
|
0.00%
0/65
|
1.6%
1/62
|
0.00%
0/33
|
0.00%
0/31
|
|
Ear and labyrinth disorders
Tympanic Membrane Perforation
|
1.5%
1/65
|
0.00%
0/62
|
0.00%
0/33
|
0.00%
0/31
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/65
|
3.2%
2/62
|
0.00%
0/33
|
0.00%
0/31
|
|
Eye disorders
Vision Blurred
|
0.00%
0/65
|
1.6%
1/62
|
0.00%
0/33
|
0.00%
0/31
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
3.1%
2/65
|
1.6%
1/62
|
0.00%
0/33
|
0.00%
0/31
|
|
Gastrointestinal disorders
Eosinophilic Oesophagitis
|
0.00%
0/65
|
1.6%
1/62
|
0.00%
0/33
|
0.00%
0/31
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/65
|
1.6%
1/62
|
0.00%
0/33
|
0.00%
0/31
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/65
|
3.2%
2/62
|
0.00%
0/33
|
0.00%
0/31
|
|
Gastrointestinal disorders
Gastritis
|
1.5%
1/65
|
0.00%
0/62
|
0.00%
0/33
|
0.00%
0/31
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
1.5%
1/65
|
0.00%
0/62
|
0.00%
0/33
|
0.00%
0/31
|
|
Gastrointestinal disorders
Haematochezia
|
1.5%
1/65
|
0.00%
0/62
|
0.00%
0/33
|
0.00%
0/31
|
|
Gastrointestinal disorders
Hiatus Hernia
|
1.5%
1/65
|
0.00%
0/62
|
0.00%
0/33
|
0.00%
0/31
|
|
Gastrointestinal disorders
Irritable Bowel Syndrome
|
1.5%
1/65
|
0.00%
0/62
|
0.00%
0/33
|
0.00%
0/31
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/65
|
4.8%
3/62
|
0.00%
0/33
|
0.00%
0/31
|
|
Gastrointestinal disorders
Regurgitation
|
1.5%
1/65
|
1.6%
1/62
|
0.00%
0/33
|
0.00%
0/31
|
|
General disorders
Chest Pain
|
0.00%
0/65
|
1.6%
1/62
|
0.00%
0/33
|
0.00%
0/31
|
|
General disorders
Chills
|
1.5%
1/65
|
0.00%
0/62
|
0.00%
0/33
|
0.00%
0/31
|
|
General disorders
Fatigue
|
0.00%
0/65
|
1.6%
1/62
|
0.00%
0/33
|
0.00%
0/31
|
|
General disorders
Influenza Like Illness
|
1.5%
1/65
|
1.6%
1/62
|
0.00%
0/33
|
0.00%
0/31
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/65
|
1.6%
1/62
|
0.00%
0/33
|
0.00%
0/31
|
|
Infections and infestations
Acute Tonsillitis
|
0.00%
0/65
|
1.6%
1/62
|
0.00%
0/33
|
0.00%
0/31
|
|
Infections and infestations
Conjunctivitis Infective
|
0.00%
0/65
|
1.6%
1/62
|
0.00%
0/33
|
0.00%
0/31
|
|
Infections and infestations
Coxsackie Viral Infection
|
1.5%
1/65
|
0.00%
0/62
|
0.00%
0/33
|
0.00%
0/31
|
|
Infections and infestations
Influenza
|
0.00%
0/65
|
3.2%
2/62
|
0.00%
0/33
|
0.00%
0/31
|
|
Infections and infestations
Lower Respiratory Tract Infection Viral
|
1.5%
1/65
|
0.00%
0/62
|
3.0%
1/33
|
0.00%
0/31
|
|
Infections and infestations
Molluscum Contagiosum
|
0.00%
0/65
|
1.6%
1/62
|
0.00%
0/33
|
0.00%
0/31
|
|
Infections and infestations
Pneumonia
|
0.00%
0/65
|
3.2%
2/62
|
0.00%
0/33
|
0.00%
0/31
|
|
Infections and infestations
Tooth Abscess
|
0.00%
0/65
|
1.6%
1/62
|
0.00%
0/33
|
0.00%
0/31
|
|
Infections and infestations
Tracheitis
|
0.00%
0/65
|
1.6%
1/62
|
0.00%
0/33
|
0.00%
0/31
|
|
Infections and infestations
Urinary Tract Infection
|
3.1%
2/65
|
1.6%
1/62
|
0.00%
0/33
|
0.00%
0/31
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
1.5%
1/65
|
0.00%
0/62
|
0.00%
0/33
|
0.00%
0/31
|
|
Injury, poisoning and procedural complications
Arthropod Sting
|
1.5%
1/65
|
0.00%
0/62
|
0.00%
0/33
|
0.00%
0/31
|
|
Injury, poisoning and procedural complications
Contusion
|
1.5%
1/65
|
1.6%
1/62
|
0.00%
0/33
|
0.00%
0/31
|
|
Injury, poisoning and procedural complications
Skin Laceration
|
1.5%
1/65
|
0.00%
0/62
|
0.00%
0/33
|
0.00%
0/31
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
0.00%
0/65
|
1.6%
1/62
|
0.00%
0/33
|
0.00%
0/31
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
1.5%
1/65
|
0.00%
0/62
|
0.00%
0/33
|
0.00%
0/31
|
|
Investigations
Body Temperature Increased
|
0.00%
0/65
|
1.6%
1/62
|
0.00%
0/33
|
0.00%
0/31
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
3.1%
2/65
|
1.6%
1/62
|
0.00%
0/33
|
0.00%
0/31
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
1.5%
1/65
|
0.00%
0/62
|
0.00%
0/33
|
0.00%
0/31
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/65
|
1.6%
1/62
|
0.00%
0/33
|
0.00%
0/31
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/65
|
1.6%
1/62
|
0.00%
0/33
|
0.00%
0/31
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/65
|
1.6%
1/62
|
0.00%
0/33
|
0.00%
0/31
|
|
Nervous system disorders
Dizziness
|
1.5%
1/65
|
1.6%
1/62
|
0.00%
0/33
|
0.00%
0/31
|
|
Nervous system disorders
Dysgeusia
|
1.5%
1/65
|
1.6%
1/62
|
0.00%
0/33
|
0.00%
0/31
|
|
Nervous system disorders
Lethargy
|
0.00%
0/65
|
1.6%
1/62
|
0.00%
0/33
|
0.00%
0/31
|
|
Psychiatric disorders
Insomnia
|
1.5%
1/65
|
0.00%
0/62
|
0.00%
0/33
|
0.00%
0/31
|
|
Psychiatric disorders
Mental Disorder
|
1.5%
1/65
|
0.00%
0/62
|
0.00%
0/33
|
0.00%
0/31
|
|
Reproductive system and breast disorders
Balanoposthitis
|
1.5%
1/65
|
0.00%
0/62
|
0.00%
0/33
|
0.00%
0/31
|
|
Respiratory, thoracic and mediastinal disorders
Adenoidal Hypertrophy
|
1.5%
1/65
|
0.00%
0/62
|
0.00%
0/33
|
0.00%
0/31
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/65
|
3.2%
2/62
|
0.00%
0/33
|
0.00%
0/31
|
|
Respiratory, thoracic and mediastinal disorders
Asthma Exercise Induced
|
0.00%
0/65
|
1.6%
1/62
|
0.00%
0/33
|
0.00%
0/31
|
|
Respiratory, thoracic and mediastinal disorders
Choking
|
0.00%
0/65
|
1.6%
1/62
|
0.00%
0/33
|
0.00%
0/31
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
1.5%
1/65
|
0.00%
0/62
|
0.00%
0/33
|
0.00%
0/31
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/65
|
1.6%
1/62
|
0.00%
0/33
|
0.00%
0/31
|
|
Respiratory, thoracic and mediastinal disorders
Increased Upper Airway Secretion
|
1.5%
1/65
|
0.00%
0/62
|
0.00%
0/33
|
0.00%
0/31
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
6.2%
4/65
|
1.6%
1/62
|
0.00%
0/33
|
0.00%
0/31
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal Erythema
|
1.5%
1/65
|
0.00%
0/62
|
0.00%
0/33
|
0.00%
0/31
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal Drip
|
1.5%
1/65
|
0.00%
0/62
|
0.00%
0/33
|
0.00%
0/31
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
1.5%
1/65
|
0.00%
0/62
|
0.00%
0/33
|
0.00%
0/31
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
1.5%
1/65
|
0.00%
0/62
|
0.00%
0/33
|
0.00%
0/31
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/65
|
1.6%
1/62
|
0.00%
0/33
|
0.00%
0/31
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/65
|
1.6%
1/62
|
0.00%
0/33
|
0.00%
0/31
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/65
|
1.6%
1/62
|
0.00%
0/33
|
0.00%
0/31
|
|
Skin and subcutaneous tissue disorders
Rash Pruritic
|
1.5%
1/65
|
0.00%
0/62
|
0.00%
0/33
|
0.00%
0/31
|
|
Skin and subcutaneous tissue disorders
Skin Exfoliation
|
0.00%
0/65
|
1.6%
1/62
|
0.00%
0/33
|
0.00%
0/31
|
|
Social circumstances
Menarche
|
0.00%
0/65
|
1.6%
1/62
|
0.00%
0/33
|
0.00%
0/31
|
|
Surgical and medical procedures
Suture Insertion
|
1.5%
1/65
|
0.00%
0/62
|
0.00%
0/33
|
0.00%
0/31
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/65
|
0.00%
0/62
|
0.00%
0/33
|
3.2%
1/31
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/65
|
0.00%
0/62
|
3.0%
1/33
|
0.00%
0/31
|
|
Immune system disorders
Atopy
|
0.00%
0/65
|
0.00%
0/62
|
3.0%
1/33
|
0.00%
0/31
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/65
|
0.00%
0/62
|
0.00%
0/33
|
3.2%
1/31
|
|
Injury, poisoning and procedural complications
Humerus Fracture
|
0.00%
0/65
|
0.00%
0/62
|
3.0%
1/33
|
0.00%
0/31
|
|
Injury, poisoning and procedural complications
Procedural Vomiting
|
0.00%
0/65
|
0.00%
0/62
|
3.0%
1/33
|
0.00%
0/31
|
|
Injury, poisoning and procedural complications
Ulna Fracture
|
0.00%
0/65
|
0.00%
0/62
|
0.00%
0/33
|
3.2%
1/31
|
|
Investigations
Beta 2 Microglobulin Urine Increased
|
0.00%
0/65
|
0.00%
0/62
|
3.0%
1/33
|
0.00%
0/31
|
|
Investigations
Blood Iron Decreased
|
0.00%
0/65
|
0.00%
0/62
|
0.00%
0/33
|
3.2%
1/31
|
|
Investigations
Serum Ferritin Decreased
|
0.00%
0/65
|
0.00%
0/62
|
3.0%
1/33
|
0.00%
0/31
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/65
|
0.00%
0/62
|
3.0%
1/33
|
0.00%
0/31
|
|
Metabolism and nutrition disorders
Iron Deficiency
|
0.00%
0/65
|
0.00%
0/62
|
3.0%
1/33
|
0.00%
0/31
|
|
Nervous system disorders
Febrile Convulsion
|
0.00%
0/65
|
0.00%
0/62
|
0.00%
0/33
|
3.2%
1/31
|
|
Reproductive system and breast disorders
Breast Mass
|
0.00%
0/65
|
0.00%
0/62
|
0.00%
0/33
|
3.2%
1/31
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial Hyperreactivity
|
0.00%
0/65
|
0.00%
0/62
|
0.00%
0/33
|
3.2%
1/31
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.00%
0/65
|
0.00%
0/62
|
0.00%
0/33
|
3.2%
1/31
|
|
Skin and subcutaneous tissue disorders
Dermatitis Allergic
|
0.00%
0/65
|
0.00%
0/62
|
3.0%
1/33
|
0.00%
0/31
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
0.00%
0/65
|
0.00%
0/62
|
0.00%
0/33
|
3.2%
1/31
|
|
Skin and subcutaneous tissue disorders
Dermatitis Diaper
|
0.00%
0/65
|
0.00%
0/62
|
0.00%
0/33
|
3.2%
1/31
|
|
Skin and subcutaneous tissue disorders
Prurigo
|
0.00%
0/65
|
0.00%
0/62
|
3.0%
1/33
|
0.00%
0/31
|
|
Surgical and medical procedures
Tooth Extraction
|
0.00%
0/65
|
0.00%
0/62
|
0.00%
0/33
|
3.2%
1/31
|
|
Infections and infestations
Folliculitis
|
0.00%
0/65
|
0.00%
0/62
|
0.00%
0/33
|
3.2%
1/31
|
|
Infections and infestations
Fungal Oesophagitis
|
0.00%
0/65
|
0.00%
0/62
|
0.00%
0/33
|
3.2%
1/31
|
|
Infections and infestations
Gastroenteritis Rotavirus
|
0.00%
0/65
|
0.00%
0/62
|
0.00%
0/33
|
3.2%
1/31
|
|
Infections and infestations
Rash Pustular
|
0.00%
0/65
|
0.00%
0/62
|
0.00%
0/33
|
3.2%
1/31
|
Additional Information
PORTFOLIO/CDT LEADER
Janssen R&D US
Phone: 1 609 730-2548
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60