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Trial record 75 of 215 for:    Lamotrigine

Clinical Study of Lamotrigine to Treat Newly Diagnosed Typical Absence Seizure in Children and Adolescents

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ClinicalTrials.gov Identifier: NCT01431976
Recruitment Status : Completed
First Posted : September 12, 2011
Results First Posted : August 27, 2014
Last Update Posted : March 8, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Epilepsy
Intervention Drug: Lamictal
Enrollment 20
Recruitment Details Participants with newly diagnosed and untreated typical absence seizure; aged 2-15 years in Japan, 2-12 years in South Korea at the time of obtaining consent; weighing at least 7 kilograms (kg); without partial seizure or generalized seizures other than typical absence; and without a history of rash associated with other treatment were enrolled.
Pre-assignment Details The study consisted of an Escalation Phase (EP), a 12-week (W) Maintenance Phase (MP), a >=2-week Taper Phase, and post-study examination within 1-4 weeks after the last dose of lamotrigine. Participants could have entered the Extension Phase (ExP) until approval for this indication or until 24 months after the Last Subject Last Visit in the MP.
Arm/Group Title Lamotrigine
Hide Arm/Group Description In the EP, lamotrigine 0.3 milligrams per kilogram per day (mg/kg/day) was administered orally once daily from Week W1 to W2, and 0.6 mg/kg/day from W3 to W4. From W5, the dose was escalated by 0.6 mg/kg/day once every 1 or 2 weeks, up to a maximum of 10.2 mg/kg/day or 400 mg/day, whichever was less (WWL), until a seizure-free (SF) status was confirmed by hyperventilation (HV)-clinical signs. After a SF confirmation, the dose was increased by one level and HV-electroencephalography was assessed twice at the same dose level to confirm the SF status. In the MP, the same dose was continued for 12 weeks. An increase/decrease in dose (0.6 mg/kg/day at >=1-week intervals) was allowed within the range of 1.2 to 10.2 mg/kg/day or 400 mg/day, WWL. In the ExP, doses of 1.2 to 10.2 mg/kg/day or 400 mg/day (WWL) were administered based on seizure status/safety. If a dose <1.2 mg/kg/day or >10.2 mg/kg/day or 400 mg/day (WWL) was necessary, the participant was withdrawn from the study.
Period Title: Overall Study
Started 20
Completed 6
Not Completed 14
Reason Not Completed
Adverse Event             6
Lack of Efficacy             2
Met Protocol-defined Stopping Criteria             4
Physician Decision             1
Withdrawal by Subject             1
Arm/Group Title Lamotrigine
Hide Arm/Group Description In the EP, lamotrigine 0.3 mg/kg/day was administered orally once daily from W1 to W2, and 0.6 mg/kg/day from W3 to W4. From W5, the dose was escalated by 0.6 mg/kg/day once every 1 or 2 weeks, up to a maximum of 10.2 mg/kg/day or 400 mg/day, WWL, until a SF status was confirmed by HV-clinical signs. After a SF confirmation, the dose was increased by one level and HV-electroencephalography was assessed twice at the same dose level to confirm the SF status. In the MP, the same dose was continued for 12 weeks. An increase/decrease in dose (0.6 mg/kg/day at >=1-week intervals) was allowed within the range of 1.2 to 10.2 mg/kg/day or 400 mg/day, WWL. In the ExP, doses of 1.2 to 10.2 mg/kg/day or 400 mg/day (WWL) were administered based on seizure status/safety. If a dose <1.2 mg/kg/day or >10.2 mg/kg/day or 400 mg/day (WWL) was necessary, the participant was withdrawn from the study.
Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants
7.7  (1.95)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
13
  65.0%
Male
7
  35.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 20 participants
East Asian Heritage 3
Japanese Heritage 16
South East Asian Heritage 1
1.Primary Outcome
Title Number of Participants Who Were Seizure Free as Confirmed by Hyperventilation (HV)-Electroencephalography (EEG) at the End of the Maintenance Phase (MP)
Hide Description EEG is a diagnostic test for epilepsy. The EEG machine records the brain’s electrical activity as a series of waveforms. HV is an activation technique used to provoke seizures during an EEG recording. An approximately 30-minute EEG with HV was performed on participants in a supine position. In the HV test, participants breathed through their mouths deeply and rapidly (at a rate of approximately 20-25 breaths/minute) for 4 continuous minutes using a pin-wheel provided to them.
Time Frame Week 12 of the Maintenance Phase (up to Study Week 50)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): all participants who took at least one dose of investigational product and contributed data to at least one efficacy measure after the first dosing of investigational product
Arm/Group Title Lamotrigine
Hide Arm/Group Description:
In the EP, lamotrigine 0.3 mg/kg/day was administered orally once daily from W1 to W2, and 0.6 mg/kg/day from W3 to W4. From W5, the dose was escalated by 0.6 mg/kg/day once every 1 or 2 weeks, up to a maximum of 10.2 mg/kg/day or 400 mg/day, WWL, until a SF status was confirmed by HV-clinical signs. After a SF confirmation, the dose was increased by one level and HV-electroencephalography was assessed twice at the same dose level to confirm the SF status. In the MP, the same dose was continued for 12 weeks. An increase/decrease in dose (0.6 mg/kg/day at >=1-week intervals) was allowed within the range of 1.2 to 10.2 mg/kg/day or 400 mg/day, WWL. In the ExP, doses of 1.2 to 10.2 mg/kg/day or 400 mg/day (WWL) were administered based on seizure status/safety. If a dose <1.2 mg/kg/day or >10.2 mg/kg/day or 400 mg/day (WWL) was necessary, the participant was withdrawn from the study.
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: Participants
7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lamotrigine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter percentage of participants
Estimated Value 35.0
Confidence Interval (2-Sided) 95%
15.39 to 59.22
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants Who Were Seizure Free as Confirmed by HV-EEG at Two Consecutive Visits in the Escalation Phase (EP)
Hide Description EEG is a diagnostic test for epilepsy. The EEG machine records the brain’s electrical activity as a series of waveforms. HV is an activation technique used to provoke seizures during an EEG recording. An approximately 30-minute EEG with HV was performed on participants in a supine position. In the HV test, participants breathed through their mouths deeply and rapidly (at a rate of approximately 20-25 breaths/minute ) for 4 continuous minutes using a pin-wheel provided to them.
Time Frame Up to Study Week 49
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Lamotrigine
Hide Arm/Group Description:
In the EP, lamotrigine 0.3 mg/kg/day was administered orally once daily from W1 to W2, and 0.6 mg/kg/day from W3 to W4. From W5, the dose was escalated by 0.6 mg/kg/day once every 1 or 2 weeks, up to a maximum of 10.2 mg/kg/day or 400 mg/day, WWL, until a SF status was confirmed by HV-clinical signs. After a SF confirmation, the dose was increased by one level and HV-electroencephalography was assessed twice at the same dose level to confirm the SF status. In the MP, the same dose was continued for 12 weeks. An increase/decrease in dose (0.6 mg/kg/day at >=1-week intervals) was allowed within the range of 1.2 to 10.2 mg/kg/day or 400 mg/day, WWL. In the ExP, doses of 1.2 to 10.2 mg/kg/day or 400 mg/day (WWL) were administered based on seizure status/safety. If a dose <1.2 mg/kg/day or >10.2 mg/kg/day or 400 mg/day (WWL) was necessary, the participant was withdrawn from the study.
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: Participants
8
3.Secondary Outcome
Title Number of Participants Who Were Seizure Free as Confirmed by HV-clinical Signs at Each Dose During the Escalation Phase
Hide Description HV is an activation technique used to provoke seizures. Participants were instructed to breathe through their mouths deeply and rapidly (at a rate of approximately 20-25 breaths/minute) for 4 continuous minutes while sitting using a pin-wheel and were observed for clinical signs of seizures like impairment of consciousness; staring; eye enrollment; eye blinking; chewing movements; hand movement; other automatisms; atonic, tonic, clonic components; autonomic components; or any other signs. During the Escalation Phase, HV-clinical signs were assessed to confirm a status of seizure free. Only participants data available at the analysis time point were analyzed (represented as n=X, X, X in category title).
Time Frame Up to Study Week 49
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Only those participants given the indicated dose of investigational product were analyzed.
Arm/Group Title Lamotrigine
Hide Arm/Group Description:
In the EP, lamotrigine 0.3 mg/kg/day was administered orally once daily from W1 to W2, and 0.6 mg/kg/day from W3 to W4. From W5, the dose was escalated by 0.6 mg/kg/day once every 1 or 2 weeks, up to a maximum of 10.2 mg/kg/day or 400 mg/day, WWL, until a SF status was confirmed by HV-clinical signs. After a SF confirmation, the dose was increased by one level and HV-electroencephalography was assessed twice at the same dose level to confirm the SF status. In the MP, the same dose was continued for 12 weeks. An increase/decrease in dose (0.6 mg/kg/day at >=1-week intervals) was allowed within the range of 1.2 to 10.2 mg/kg/day or 400 mg/day, WWL. In the ExP, doses of 1.2 to 10.2 mg/kg/day or 400 mg/day (WWL) were administered based on seizure status/safety. If a dose <1.2 mg/kg/day or >10.2 mg/kg/day or 400 mg/day (WWL) was necessary, the participant was withdrawn from the study.
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: Participants
0.6 mg/kg, n=17 1
1.2 mg/kg, n=17 1
1.8 mg/kg, n=16 2
2.4 mg/kg, n=16 2
3.0 mg/kg, n=16 2
3.6 mg/kg, n=15 1
4.2 mg/kg, n=15 0
4.8 mg/kg, n=14 4
5.4 mg/kg, n=14 1
6.0 mg/kg, n=11 1
6.6 mg/kg, n=11 0
7.2 mg/kg, n=9 3
7.8 mg/kg, n=9 0
8.4 mg/kg, n=6 2
9.0 mg/kg, n=6 1
9.6 mg/kg, n=1 1
4.Secondary Outcome
Title Number of Participants Who Were Seizure Free as Confirmed by HV-clinical Signs During Week 4 and Week 8 of the Maintenance Phase
Hide Description HV is an activation technique used to provoke seizures. Participants were instructed to breathe through their mouths deeply and rapidly (at a rate of approximately 20-25 breaths/minute) for 4 continuous minutes while sitting using a pin-wheel and were observed for clinical signs of seizures like impairment of consciousness; staring; eye enrollment; eye blinking; chewing movements; hand movement; other automatisms; atonic, tonic, clonic components; autonomic components; or any other signs. During the Maintenace Phase, HV-clinical signs were assessed at Visit 1 (Week 4) and Visit 2 (Week 4).
Time Frame Week 4 and Week 8 of the Maintenance Phase (up to Study Weeks 42 and 46, respectively)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Only those participants who were dosed with investigational product at the indicated time points were analyzed.
Arm/Group Title Lamotrigine
Hide Arm/Group Description:
In the EP, lamotrigine 0.3 mg/kg/day was administered orally once daily from W1 to W2, and 0.6 mg/kg/day from W3 to W4. From W5, the dose was escalated by 0.6 mg/kg/day once every 1 or 2 weeks, up to a maximum of 10.2 mg/kg/day or 400 mg/day, WWL, until a SF status was confirmed by HV-clinical signs. After a SF confirmation, the dose was increased by one level and HV-electroencephalography was assessed twice at the same dose level to confirm the SF status. In the MP, the same dose was continued for 12 weeks. An increase/decrease in dose (0.6 mg/kg/day at >=1-week intervals) was allowed within the range of 1.2 to 10.2 mg/kg/day or 400 mg/day, WWL. In the ExP, doses of 1.2 to 10.2 mg/kg/day or 400 mg/day (WWL) were administered based on seizure status/safety. If a dose <1.2 mg/kg/day or >10.2 mg/kg/day or 400 mg/day (WWL) was necessary, the participant was withdrawn from the study.
Overall Number of Participants Analyzed 7
Measure Type: Number
Unit of Measure: Participants
Week 4 7
Week 8 7
5.Secondary Outcome
Title Number of Participants Who Were Seizure Free as Confirmed by HV-EEG at Each Assessment Point in the Extension Phase (ExP)
Hide Description EEG is a diagnostic test for epilepsy. The EEG machine records the brain’s electrical activity as a series of waveforms. HV is an activation technique used to provoke seizures during an EEG recording. An approximately 30-minute EEG with HV was performed on participants in a supine position. In the HV test, participants breathed through their mouths deeply and rapidly (at a rate of approximately 20-25 breaths/minute ) for 4 continuous minutes using a pin-wheel provided to them. Only participants data available at the analysis time point were analyzed (represented as n=X, X, X in category title).
Time Frame Extension Week 12 (Extension Visit 1 [Ext-V1]), every 24 weeks after Ext-V1 and until withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Only those participants given the indicated dose of investigational product were analyzed.
Arm/Group Title Lamotrigine
Hide Arm/Group Description:
In the EP, lamotrigine 0.3 mg/kg/day was administered orally once daily from W1 to W2, and 0.6 mg/kg/day from W3 to W4. From W5, the dose was escalated by 0.6 mg/kg/day once every 1 or 2 weeks, up to a maximum of 10.2 mg/kg/day or 400 mg/day, WWL, until a SF status was confirmed by HV-clinical signs. After a SF confirmation, the dose was increased by one level and HV-electroencephalography was assessed twice at the same dose level to confirm the SF status. In the MP, the same dose was continued for 12 weeks. An increase/decrease in dose (0.6 mg/kg/day at >=1-week intervals) was allowed within the range of 1.2 to 10.2 mg/kg/day or 400 mg/day, WWL. In the ExP, doses of 1.2 to 10.2 mg/kg/day or 400 mg/day (WWL) were administered based on seizure status/safety. If a dose <1.2 mg/kg/day or >10.2 mg/kg/day or 400 mg/day (WWL) was necessary, the participant was withdrawn from the study.
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: Participants
Extension Week 12, n=7 6
Extension Week 36, n=7 5
Extension Week 60, n=7 6
Extension Week 84, n=6 6
Extension Week 108, n=6 6
Extension Week 132, n=6 6
Extension Week 156, n=2 2
6.Secondary Outcome
Title Number of Participants Who Were Seizure Free as Confirmed by HV-clinical Signs at Each Assessment Point in the Extension Phase (ExP)
Hide Description HV is an activation technique used to provoke seizures. Participants were instructed to breathe through their mouths deeply and rapidly (at a rate of approximately 20-25 breaths/minute) for 4 continuous minutes while sitting using a pin-wheel and were observed for clinical signs of seizures like impairment of consciousness; staring; eye enrollment; eye blinking; chewing movements; hand movement; other automatisms; atonic, tonic, clonic components; autonomic components; or any other signs. During the ExP, HV-clinical signs were assessed to confirm a status of seizure free. Only participants data available at the analysis time point were analyzed (represented as n=X, X, X in category title).
Time Frame Extension Week 24 (Extension Visit 2 [Ext-V2], every 24 weeks after the Ext-V2 and until withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Only those participants given the indicated dose of investigational product were analyzed.
Arm/Group Title Lamotrigine
Hide Arm/Group Description:
In the EP, lamotrigine 0.3 mg/kg/day was administered orally once daily from W1 to W2, and 0.6 mg/kg/day from W3 to W4. From W5, the dose was escalated by 0.6 mg/kg/day once every 1 or 2 weeks, up to a maximum of 10.2 mg/kg/day or 400 mg/day, WWL, until a SF status was confirmed by HV-clinical signs. After a SF confirmation, the dose was increased by one level and HV-electroencephalography was assessed twice at the same dose level to confirm the SF status. In the MP, the same dose was continued for 12 weeks. An increase/decrease in dose (0.6 mg/kg/day at >=1-week intervals) was allowed within the range of 1.2 to 10.2 mg/kg/day or 400 mg/day, WWL. In the ExP, doses of 1.2 to 10.2 mg/kg/day or 400 mg/day (WWL) were administered based on seizure status/safety. If a dose <1.2 mg/kg/day or >10.2 mg/kg/day or 400 mg/day (WWL) was necessary, the participant was withdrawn from the study.
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: Participants
Extension Week 24, n=7 5
Extension Week 48, n=7 6
Extension Week 72, n=7 5
Extension Week 96, n=6 6
Extension Week 120, n=6 5
Extension Week 144, n=4 2
Extension Week 168, n=1 1
7.Secondary Outcome
Title Number of Days With Seizure Episodes Per Week in the Main Study Phase (Fixed Escalation Phase [FEP], Escalation Phase [EP], Maintenance Phase [MP]), and FEP+EP+MP)
Hide Description Participants were asked to record the seizure codes, seizure duration, and their physical condition in a diary provided. Only participants data available at the analysis time point were analyzed (represented as n=X, X, X in category title)
Time Frame Up to Study Week 50
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Lamotrigine
Hide Arm/Group Description:
In the EP, lamotrigine 0.3 mg/kg/day was administered orally once daily from W1 to W2, and 0.6 mg/kg/day from W3 to W4. From W5, the dose was escalated by 0.6 mg/kg/day once every 1 or 2 weeks, up to a maximum of 10.2 mg/kg/day or 400 mg/day, WWL, until a SF status was confirmed by HV-clinical signs. After a SF confirmation, the dose was increased by one level and HV-electroencephalography was assessed twice at the same dose level to confirm the SF status. In the MP, the same dose was continued for 12 weeks. An increase/decrease in dose (0.6 mg/kg/day at >=1-week intervals) was allowed within the range of 1.2 to 10.2 mg/kg/day or 400 mg/day, WWL. In the ExP, doses of 1.2 to 10.2 mg/kg/day or 400 mg/day (WWL) were administered based on seizure status/safety. If a dose <1.2 mg/kg/day or >10.2 mg/kg/day or 400 mg/day (WWL) was necessary, the participant was withdrawn from the study.
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: Days
Fixed Escalation Phase, n=20 4.93  (1.488)
Escalation Phase, n=17 2.60  (2.060)
Maintenance Phase, n=8 0.06  (0.161)
FEP+EP+MP, n=20 2.98  (1.976)
8.Secondary Outcome
Title Number of Days With Seizure Episodes Per Week in the Extension Phase (ExP) Overall
Hide Description Participants were asked to record the seizure codes, seizure duration, and their physical condition in a diary provided.
Time Frame Extension Week 12 (Extension Visit 1 [Ext-V1], every 12 week after Ext-V1 and until withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Only those participants given the indicated dose of investigational product were analyzed.
Arm/Group Title Lamotrigine
Hide Arm/Group Description:
In the EP, lamotrigine 0.3 mg/kg/day was administered orally once daily from W1 to W2, and 0.6 mg/kg/day from W3 to W4. From W5, the dose was escalated by 0.6 mg/kg/day once every 1 or 2 weeks, up to a maximum of 10.2 mg/kg/day or 400 mg/day, WWL, until a SF status was confirmed by HV-clinical signs. After a SF confirmation, the dose was increased by one level and HV-electroencephalography was assessed twice at the same dose level to confirm the SF status. In the MP, the same dose was continued for 12 weeks. An increase/decrease in dose (0.6 mg/kg/day at >=1-week intervals) was allowed within the range of 1.2 to 10.2 mg/kg/day or 400 mg/day, WWL. In the ExP, doses of 1.2 to 10.2 mg/kg/day or 400 mg/day (WWL) were administered based on seizure status/safety. If a dose <1.2 mg/kg/day or >10.2 mg/kg/day or 400 mg/day (WWL) was necessary, the participant was withdrawn from the study.
Overall Number of Participants Analyzed 7
Mean (Standard Deviation)
Unit of Measure: Days
0.03  (0.048)
Time Frame Serious adverse events (SAEs) and non-serious AEs were collected from study medication start until the end of treatment (up to Study Week 50) (EP, MP, and ExP).
Adverse Event Reporting Description SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had taken at least one dose of investigational product.
 
Arm/Group Title Lamotrigine
Hide Arm/Group Description In the EP, lamotrigine 0.3 mg/kg/day was administered orally once daily from W1 to W2, and 0.6 mg/kg/day from W3 to W4. From W5, the dose was escalated by 0.6 mg/kg/day once every 1 or 2 weeks, up to a maximum of 10.2 mg/kg/day or 400 mg/day, WWL, until a SF status was confirmed by HV-clinical signs. After a SF confirmation, the dose was increased by one level and HV-electroencephalography was assessed twice at the same dose level to confirm the SF status. In the MP, the same dose was continued for 12 weeks. An increase/decrease in dose (0.6 mg/kg/day at &gt;=1-week intervals) was allowed within the range of 1.2 to 10.2 mg/kg/day or 400 mg/day, WWL. In the ExP, doses of 1.2 to 10.2 mg/kg/day or 400 mg/day (WWL) were administered based on seizure status/safety. If a dose &lt;1.2 mg/kg/day or &gt;10.2 mg/kg/day or 400 mg/day (WWL) was necessary, the participant was withdrawn from the study.
All-Cause Mortality
Lamotrigine
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Lamotrigine
Affected / at Risk (%)
Total   0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lamotrigine
Affected / at Risk (%)
Total   17/20 (85.00%) 
Gastrointestinal disorders   
Stomatitis  1  2/20 (10.00%) 
Abdominal pain  1  1/20 (5.00%) 
Constipation  1  1/20 (5.00%) 
Diarrhoea  1  1/20 (5.00%) 
Enteritis  1  1/20 (5.00%) 
Enterocolitis  1  1/20 (5.00%) 
General disorders   
Pain  1  1/20 (5.00%) 
Immune system disorders   
Drug hypersensitivity  1  1/20 (5.00%) 
Seasonal allergy  1  1/20 (5.00%) 
Infections and infestations   
Bronchitis  1  5/20 (25.00%) 
Nasopharyngitis  1  7/20 (35.00%) 
Upper respiratory tract infection  1  3/20 (15.00%) 
Cellulitis  1  1/20 (5.00%) 
Gastroenteritis  1  1/20 (5.00%) 
Influenza  1  5/20 (25.00%) 
Paronychia  1  1/20 (5.00%) 
Pharyngitis  1  2/20 (10.00%) 
Pneumonia mycoplasmal  1  1/20 (5.00%) 
Scarlet fever  1  1/20 (5.00%) 
Varicella  1  2/20 (10.00%) 
Adenovirus infection  1  1/20 (5.00%) 
Folliculitis  1  1/20 (5.00%) 
Otitis media acute  1  1/20 (5.00%) 
Rhinitis  1  1/20 (5.00%) 
Sinusitis  1  1/20 (5.00%) 
Conjunctivitis  1  2/20 (10.00%) 
Injury, poisoning and procedural complications   
Fracture  1  1/20 (5.00%) 
Arthropod bite  1  1/20 (5.00%) 
Arthropod sting  1  3/20 (15.00%) 
Chillblains  1  1/20 (5.00%) 
Skin abrasion  1  1/20 (5.00%) 
Hand fracture  1  1/20 (5.00%) 
Investigations   
Alanine aminotransferase increased  1  1/20 (5.00%) 
Aspartate aminotransferase increased  1  1/20 (5.00%) 
Metabolism and nutrition disorders   
Decreased appetite  1  1/20 (5.00%) 
Dehydration  1  1/20 (5.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Skin papilloma  1  1/20 (5.00%) 
Nervous system disorders   
Headache  1  4/20 (20.00%) 
Psychomotor hyperactivity  1  1/20 (5.00%) 
Febrile convulsion  1  1/20 (5.00%) 
Renal and urinary disorders   
Proteinuria  1  1/20 (5.00%) 
Hematuria  1  1/20 (5.00%) 
Respiratory, thoracic and mediastinal disorders   
Asthma  1  1/20 (5.00%) 
Epistaxis  1  1/20 (5.00%) 
Skin and subcutaneous tissue disorders   
Rash  1  6/20 (30.00%) 
Drug eruption  1  2/20 (10.00%) 
Dermatitis atopic  1  1/20 (5.00%) 
Eczema  1  2/20 (10.00%) 
Acne  1  1/20 (5.00%) 
Dry skin  1  1/20 (5.00%) 
Urticaria  1  1/20 (5.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01431976     History of Changes
Other Study ID Numbers: 115377
First Submitted: September 1, 2011
First Posted: September 12, 2011
Results First Submitted: August 14, 2014
Results First Posted: August 27, 2014
Last Update Posted: March 8, 2017