Long Term Study of Genotropin (Somatropin) for Short Children Born Small for Gestational Age (SGA)

• ClinicalTrials.gov Identifier: NCT01859949
• Recruitment Status: Completed
• First Posted: May 22, 2013
• Results First Posted: March 15, 2016
• Last Update Posted: May 3, 2016
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Short Stature Born Small for Gestational Age (SGA)
• Intervention: Drug: Genotropin (somatropin)
• Enrollment: 62

Participant Flow

Recruitment Details
Pre-assignment Details	Before enrolled this study, participants with short stature due to SGA had completed the 1-year(12-month) treatment in previous study. Out of 62 participants who were enrolled this study, 61 participants were treated.

Arm/Group Title	Dose-Increasing Group	Dose-Remaining Group
Arm/Group Description	Participants who were treated with somatropin 0.033 mg/kg/day in previous study for 12 months received a dose of 0.067 mg/kg/day	Participants who were treated with somatropin 0.067 mg/kg/day in previous study for 12 months were maintained on the same dose
Period Title: Overall Study
Started	29 [1]	32 [1]
Completed	15	15
Not Completed	14	17
Reason Not Completed
Family Matters	0	1
Physician Decision	2	4
Withdrawal by Subject	11	10
Protocol Violation	1	1
Adverse Event	0	1
[1] Treated participants

Baseline Characteristics

Arm/Group Title		Dose-Increasing Group	Dose-Remaining Group	Total
Arm/Group Description		Participants who were treated with somatropin 0.033 mg/kg/day in previous study for 12 months received a dose of 0.067 mg/kg/day	Participants who were treated with somatropin 0.067 mg/kg/day in previous study for 12 months were maintained on the same dose	Total of all reporting groups
Overall Number of Baseline Participants		29	32	61
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	29 participants	32 participants	61 participants
		5.20 (1.64)	5.40 (1.27)	5.31 (1.45)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	29 participants	32 participants	61 participants
	Female	14 48.3%	14 43.8%	28 45.9%
	Male	15 51.7%	18 56.3%	33 54.1%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description	[Not Specified]
Time Frame	Month 12 (at the end of previous study) to 156

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS) included participants who received at least 1 dose of study medication and had at least one observation after enrollment of this study.

Arm/Group Title	Dose-Increasing Group	Dose-Remaining Group
Arm/Group Description:	Participants who were treated with somatropin 0.033 mg/kg/day in previous study for 12 months received a dose of 0.067 mg/kg/day	Participants who were treated with somatropin 0.067 mg/kg/day in previous study for 12 months were maintained on the same dose
Overall Number of Participants Analyzed	29	32
Measure Type: Number; Unit of Measure: participant
AE	27	31
SAE	10	5

2. Secondary Outcome

Title	Height Velocity Standard Deviation Score (SDS) for Chronological Age
Description	Height velocity is the yearly height gain. Height velocity SDS is calculated as following formula; Height velocity SDS = (height velocity - mean) / standard deviation, where mean and standard deviation were based on standard Japanese values of the participants age and gender. The scores were centred around zero. Negative score indicated a participant was smaller for their age/gender.
Time Frame	Month 12 (at the end of previous study) to 156

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS) included participants who received at least 1 dose of study medication and had at least one observation after enrollment of this study.

Arm/Group Title	Dose-Increasing Group	Dose-Remaining Group
Arm/Group Description:	Participants who were treated with somatropin 0.033 mg/kg/day in previous study for 12 months received a dose of 0.067 mg/kg/day	Participants who were treated with somatropin 0.067 mg/kg/day in previous study for 12 months were maintained on the same dose
Overall Number of Participants Analyzed	29	32
Mean (Standard Deviation); Unit of Measure: SDS
Month 12 to 24 (Increasing: n=28, Remaining: n=32)	2.782 (1.978)	2.595 (1.731)
Month 24 to36 (Increasing:n=26, Remaining:n=28)	1.812 (1.526)	1.696 (2.111)
Month 36 to 48 (Increasing: n=24, Remaining: n=23)	1.480 (1.543)	0.824 (1.527)
Month 48 to 60 (Increasing: n=21, Remaining: n=20)	-0.041 (2.081)	0.480 (1.651)
Month 60 to 72 (Increasing: n=20, Remaining: n=16)	-0.293 (1.585)	-0.046 (2.434)
Month 72 to 84 (Increasing: n=15, Remaining: n=16)	-0.488 (3.117)	-1.511 (2.692)
Month 84 to 96 (Increasing: n=11, Remaining: n=14)	0.263 (1.802)	-0.114 (1.964)
Month 96 to 108 (Increasing: n=9, Remaining: n=8)	0.521 (2.058)	-0.466 (2.055)
Month 108 to 120 (Increasing: n=6, Remaining: n=6)	-0.668 (2.126)	-0.590 (2.693)
Month 120 to 132 (Increasing: n=5, Remaining: n=4)	-1.080 (1.953)	1.173 (3.042)
Month 132 to 144 (Increasing: n=4, Remaining: n=2)	2.655 (4.329)	0.730 (2.022)
Month 144 to 156 (Increasing: n=3, Remaining: n=0)	3.373 (1.995)	NA [1] (NA)

[1]

Zero participants analyzed at this time point.

3. Secondary Outcome

Title	Height Velocity
Description	Height velocity is the yearly height gain
Time Frame	Month 12 (at the end of previous study) to 156

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS) included participants who received at least 1 dose of study medication and had at least one observation after enrollment of this study.

Arm/Group Title	Dose-Increasing Group	Dose-Remaining Group
Arm/Group Description:	Participants who were treated with somatropin 0.033 mg/kg/day in previous study for 12 months received a dose of 0.067 mg/kg/day	Participants who were treated with somatropin 0.067 mg/kg/day in previous study for 12 months were maintained on the same dose
Overall Number of Participants Analyzed	29	32
Mean (Standard Deviation); Unit of Measure: cm/year
Month 12 to 24 (Increasing: n=28, Remaining: n=32)	7.83 (1.33)	7.70 (1.19)
Month 24 to 36 (Increasing: n=26, Remaining: n=28)	6.88 (0.94)	6.75 (1.52)
Month 36 to 48 (Increasing: n=24, Remaining: n=23)	6.68 (0.98)	6.08 (1.14)
Month 48 to 60 (Increasing: n=21, Remaining: n=20)	6.06 (1.49)	6.30 (1.24)
Month 60 to 72 (Increasing: n=20, Remaining: n=16)	6.08 (1.45)	6.49 (1.37)
Month 72 to 84 (Increasing: n=15, Remaining: n=16)	4.89 (2.18)	4.88 (1.86)
Month 84 to 96 (Increasing: n=11, Remaining: n=14)	5.16 (1.20)	4.82 (2.12)
Month 96 to 108 (Increasing: n=9, Remaining: n=8)	5.18 (2.16)	5.55 (2.42)
Month 108 to 120 (Increasing: n=6, Remaining: n=6)	5.72 (2.24)	5.03 (1.86)
Month 120 to 132 (Increasing: n=5, Remaining: n=4)	4.84 (1.30)	4.30 (1.84)
Month 132 to 144 (Increasing: n=4, Remaining: n=2)	4.38 (1.10)	2.60 (0.14)
Month 144 to 156(Increasing: n=3, Remaining: n=0)	3.10 (1.92)	NA [1] (NA)

[1]

Zero participants analyzed at this time point.

4. Secondary Outcome

Title	Height SDS for Chronological Age
Description	Height SDS is calculated as following formula; Height SDS = (height - mean) / standard deviation, where mean and standard deviation were based on standard Japanese values on the participant age and gender. The scores were centred around zero. Negative score indicated a participant was smaller for their age/gender.
Time Frame	Month 12 (at the end of previous study) to 156

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS) included participants who received at least 1 dose of study medication and had at least one observation after enrollment of this study.

Arm/Group Title	Dose-Increasing Group	Dose-Remaining Group
Arm/Group Description:	Participants who were treated with somatropin 0.033 mg/kg/day in previous study for 12 months received a dose of 0.067 mg/kg/day	Participants who were treated with somatropin 0.067 mg/kg/day in previous study for 12 months were maintained on the same dose
Overall Number of Participants Analyzed	29	32
Mean (Standard Deviation); Unit of Measure: SDS
Month 12 (Increasing: n=29, Remaining: n=32)	-2.53 (0.92)	-2.17 (0.96)
Month 24 (Increasing: n=28, Remaining: n=32)	-2.02 (0.97)	-1.70 (1.03)
Month 36 (Increasing: n=26, Remaining: n=28)	-1.80 (0.99)	-1.53 (1.10)
Month 48 (Increasing: n=24, Remaining: n=23)	-1.48 (1.05)	-1.49 (1.15)
Month 60 (Increasing: n=21, Remaining: n=20)	-1.53 (1.06)	-1.44 (1.10)
Month 72 (Increasing: n=20, Remaining: n=16)	-1.56 (1.11)	-1.43 (1.06)
Month 84 (Increasing: n=15, Remaining: n=16)	-1.73 (1.13)	-1.58 (1.17)
Month 96 (Increasing: n=11, Remaining: n=14)	-1.52 (0.89)	-1.87 (1.36)
Month 108 (Increasing: n=9, Remaining: n=8)	-1.52 (1.01)	-1.63 (1.48)
Month 120 (Increasing: n=6, Remaining: n=6)	-1.52 (1.20)	-1.25 (0.59)
Month 132 (Increasing: n=5, Remaining: n=4)	-1.96 (1.11)	-0.98 (0.51)
Month 144 (Increasing: n=4, Remaining: n=2)	-1.73 (0.87)	-0.70 (0.42)
Month 156 (Increasing: n=3, Remaining: n=0)	-1.77 (0.76)	NA [1] (NA)

[1]

Zero participants analyzed at this time point.

5. Secondary Outcome

Title	Height Velocity SDS for Bone Age
Description	To measure bone age, X-ray images of the left hand were centrally assessed by an independent specialist using the Tanner-Whitehouse 2 (RUS) method standardized for Japanese children. Height velocity is the yearly height gain. Height velocity SDS for bone age is calculated as following formula; Height velocity SDS = (height velocity - mean) / standard deviation, where mean and standard deviation were based on standard Japanese values corresponding to bone age and gender. The scores were centred around zero. Negative score indicated a participant was smaller for their age/gender.
Time Frame	Month 12 (at the end of previous study) to 156

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS) included participants who received at least 1 dose of study medication and had at least one observation after enrollment of this study.

Arm/Group Title	Dose-Increasing Group	Dose-Remaining Group
Arm/Group Description:	Participants who were treated with somatropin 0.033 mg/kg/day in previous study for 12 months received a dose of 0.067 mg/kg/day	Participants who were treated with somatropin 0.067 mg/kg/day in previous study for 12 months were maintained on the same dose
Overall Number of Participants Analyzed	29	32
Mean (Standard Deviation); Unit of Measure: SDS
Month 12 to 24 (Increasing: n=26, Remaining: n=31)	2.586 (2.268)	2.461 (1.990)
Month 24 to 36 (Increasing: n=24, Remaining: n=27)	1.503 (1.830)	1.091 (1.852)
Month 36 to 48 (Increasing: n=22, Remaining: n=22)	1.196 (1.409)	0.510 (1.809)
Month 48 to 60 (Increasing: n=20, Remaining: n=19)	-0.062 (1.775)	0.913 (2.146)
Month 60 to 72 (Increasing: n=16, Remaining: n=14)	0.281 (2.814)	0.949 (2.729)
Month 72 to 84 (Increasing: n=13, Remaining: n=13)	-1.249 (2.558)	0.932 (2.545)
Month 84 to 96 (Increasing: n=10, Remaining: n=13)	0.804 (3.440)	0.286 (2.351)
Month 96 to 108 (Increasing: n=8, Remaining: n=7)	-0.634 (2.419)	-0.223 (1.352)
Month 108 to 120 (Increasing: n=5, Remaining: n=5)	0.070 (4.120)	0.532 (1.809)
Month 120 to 132 (Increasing: n=4, Remaining: n=4)	1.553 (3.019)	2.718 (0.864)
Month 132 to 144 (Increasing: n=3, Remaining: n=2)	2.310 (1.711)	2.185 (0.304)
Month 144 to 156 (Increasing: n=2, Remaining: n=0)	2.710 (2.942)	NA [1] (NA)

[1]

Zero participants analyzed at this time point.

6. Secondary Outcome

Title	Height SDS for Bone Age
Description	To measure bone age, X-ray images of the left hand were centrally assessed by an independent specialist using the Tanner-Whitehouse 2 (RUS) method standardized for Japanese children. Height SDS for bone age is calculated as following formula; Height SDS = (height - mean) / standard deviation, where mean and standard deviation were based on standard Japanese values corresponding to bone age and gender. The scores were centred around zero. Negative score indicated a participant was smaller for their age/gender.
Time Frame	Month 12 (at the end of previous study) to 156

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS) included participants who received at least 1 dose of study medication and had at least one observation after enrollment of this study.

Arm/Group Title	Dose-Increasing Group	Dose-Remaining Group
Arm/Group Description:	Participants who were treated with somatropin 0.033 mg/kg/day in previous study for 12 months received a dose of 0.067 mg/kg/day	Participants who were treated with somatropin 0.067 mg/kg/day in previous study for 12 months were maintained on the same dose
Overall Number of Participants Analyzed	29	32
Mean (Standard Deviation); Unit of Measure: SDS
Month 12 (Increasing: n=27, Remaining: n=31)	-1.19 (1.20)	-0.68 (1.54)
Month 24 (Increasing: n=26, Remaining: n=31)	-1.15 (1.15)	-0.88 (1.79)
Month 36 (Increasing: n=24, Remaining: n=27)	-1.20 (1.35)	-1.17 (1.62)
Month 48 (Increasing: n=22, Remaining: n=22)	-0.74 (1.32)	-1.46 (1.01)
Month 60 (Increasing: n=20, Remaining: n=19)	-1.16 (1.21)	-1.80 (0.97)
Month 72 (Increasing: n=16, Remaining: n=14)	-1.78 (1.02)	-1.70 (0.77)
Month 84 (Increasing: n=13, Remaining: n=13)	-1.85 (1.17)	-2.15 (0.92)
Month 96 (Increasing: n=10, Remaining: n=13)	-1.77 (1.12)	-2.27 (1.06)
Month 108 (Increasing: n=8, Remaining: n=7)	-1.41 (0.97)	-1.94 (1.37)
Month 120 (Increasing: n=5, Remaining: n=5)	-1.58 (1.50)	-1.38 (0.98)
Month 132 (Increasing: n=4, Remaining: n=4)	-2.10 (1.21)	-0.98 (0.74)
Month 144 (Increasing: n=3, Remaining: n=2)	-1.40 (0.17)	-0.65 (0.64)
Month 156 (Increasing: n=2, Remaining: n=0)	-1.55 (0.92)	NA [1] (NA)

[1]

Zero participants analyzed at this time point.

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Dose-Increasing Group	Dose-Remainig Group
Arm/Group Description	Participants who were treated with somatropin 0.033 mg/kg/day in previous study for 12 months received a dose of 0.067 mg/kg/day	Participants in the 0.067 mg/kg/day group in previous study were maintained on the dose in this expention study
All-Cause Mortality
	Dose-Increasing Group	Dose-Remainig Group
	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--
Serious Adverse Events
	Dose-Increasing Group	Dose-Remainig Group
	Affected / at Risk (%)	Affected / at Risk (%)
Total	10/29 (34.48%)	5/32 (15.63%)
Congenital, familial and genetic disorders
HYPOSPADIAS † 1	1/29 (3.45%)	0/32 (0.00%)
CRYPTORCHISM † 1	1/29 (3.45%)	0/32 (0.00%)
Ear and labyrinth disorders
DEAFNESS † 1	1/29 (3.45%)	0/32 (0.00%)
Endocrine disorders
ADENOID HYPERTROPHY † 1	1/29 (3.45%)	2/32 (6.25%)
Eye disorders
RETINAL DETACHMENT † 1	0/29 (0.00%)	1/32 (3.13%)
Gastrointestinal disorders
GASTROENTERITIS † 1	2/29 (6.90%)	0/32 (0.00%)
General disorders
INFLICTED INJURY † 1	1/29 (3.45%)	0/32 (0.00%)
Hepatobiliary disorders
HEPATIC FUNCTION ABNORMAL † 1	1/29 (3.45%)	0/32 (0.00%)
Infections and infestations
INFECTION VIRAL † 1	0/29 (0.00%)	1/32 (3.13%)
OTITIS MEDIA † 1	1/29 (3.45%)	1/32 (3.13%)
HEALING IMPAIRED † 1	0/29 (0.00%)	1/32 (3.13%)
Reproductive system and breast disorders
HERNIA INGUINAL † 1	1/29 (3.45%)	1/32 (3.13%)
OVARIAN DISORDER † 1	1/29 (3.45%)	0/32 (0.00%)
Respiratory, thoracic and mediastinal disorders
PHARYNGITIS † 1	1/29 (3.45%)	2/32 (6.25%)
PNEUMONIA † 1	1/29 (3.45%)	0/32 (0.00%)
UPPER RESP TRACT INFECTION † 1	1/29 (3.45%)	0/32 (0.00%)
BRONCHITIS † 1	1/29 (3.45%)	0/32 (0.00%)
ASTHMA † 1	1/29 (3.45%)	0/32 (0.00%)
† Indicates events were collected by systematic assessment; 1 Term from vocabulary, WHO-ART, 2001(014)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Dose-Increasing Group	Dose-Remainig Group
	Affected / at Risk (%)	Affected / at Risk (%)
Total	27/29 (93.10%)	31/32 (96.88%)
Blood and lymphatic system disorders
EOSINOPHILIA † 1	2/29 (6.90%)	3/32 (9.38%)
LEUKOCYTOSIS † 1	2/29 (6.90%)	4/32 (12.50%)
LYMPHADENOPATHY † 1	1/29 (3.45%)	3/32 (9.38%)
LYMPHOCYTES ATYPICA † 1	2/29 (6.90%)	0/32 (0.00%)
Cardiac disorders
HYPOTENSION POSTURAL † 1	2/29 (6.90%)	1/32 (3.13%)
Congenital, familial and genetic disorders
SKELETAL MALFORMATION † 1	0/29 (0.00%)	2/32 (6.25%)
TOOTH MALFORMATION † 1	2/29 (6.90%)	1/32 (3.13%)
Endocrine disorders
SIALOADENITIS † 1	3/29 (10.34%)	2/32 (6.25%)
Eye disorders
CONJUNCTIVITIS † 1	8/29 (27.59%)	12/32 (37.50%)
EYE ABNORMALITY † 1	4/29 (13.79%)	5/32 (15.63%)
MYOPIA † 1	2/29 (6.90%)	0/32 (0.00%)
Gastrointestinal disorders
CONSTIPATION † 1	3/29 (10.34%)	4/32 (12.50%)
DIARRHOEA † 1	5/29 (17.24%)	2/32 (6.25%)
VOMITING † 1	5/29 (17.24%)	3/32 (9.38%)
ABDOMINAL PAIN † 1	0/29 (0.00%)	2/32 (6.25%)
GASTROENTERITIS † 1	17/29 (58.62%)	10/32 (31.25%)
NAUSEA † 1	1/29 (3.45%)	2/32 (6.25%)
STOMATITIS † 1	2/29 (6.90%)	1/32 (3.13%)
TOOTH CARIES † 1	4/29 (13.79%)	2/32 (6.25%)
TOOTH DISORDER † 1	1/29 (3.45%)	3/32 (9.38%)
ENTEROCOLITIS † 1	0/29 (0.00%)	2/32 (6.25%)
General disorders
PURPURA † 1	6/29 (20.69%)	5/32 (15.63%)
HAEMATOMA † 1	2/29 (6.90%)	0/32 (0.00%)
ALLERGIC REACTION † 1	0/29 (0.00%)	3/32 (9.38%)
FEVER † 1	11/29 (37.93%)	1/32 (3.13%)
PAIN † 1	0/29 (0.00%)	2/32 (6.25%)
INFLUENZA-LIKE SYMPTOMS † 1	16/29 (55.17%)	15/32 (46.88%)
VARICELLA † 1	3/29 (10.34%)	2/32 (6.25%)
INFLICTED INJURY † 1	2/29 (6.90%)	4/32 (12.50%)
MOLLUSCUM CONTAGIOSUM † 1	0/29 (0.00%)	2/32 (6.25%)
SCOLIOSIS † 1	1/29 (3.45%)	2/32 (6.25%)
LACERATION † 1	1/29 (3.45%)	3/32 (9.38%)
Hepatobiliary disorders
SGOT INCREASED † 1	3/29 (10.34%)	1/32 (3.13%)
SGPT INCREASED † 1	3/29 (10.34%)	1/32 (3.13%)
Infections and infestations
INFECTION BACTERIAL † 1	4/29 (13.79%)	6/32 (18.75%)
INFECTION VIRAL † 1	2/29 (6.90%)	0/32 (0.00%)
OTITIS MEDIA † 1	13/29 (44.83%)	14/32 (43.75%)
HERPES ZOSTER † 1	2/29 (6.90%)	1/32 (3.13%)
ABSCESS † 1	0/29 (0.00%)	2/32 (6.25%)
Injury, poisoning and procedural complications
INJECTION SITE BLEEDING † 1	2/29 (6.90%)	0/32 (0.00%)
STING † 1	1/29 (3.45%)	4/32 (12.50%)
Metabolism and nutrition disorders
GLUCOSE TOLERANCE ABNORMAL † 1	1/29 (3.45%)	3/32 (9.38%)
Musculoskeletal and connective tissue disorders
ARTHRALGIA † 1	4/29 (13.79%)	5/32 (15.63%)
Nervous system disorders
HEADACHE † 1	4/29 (13.79%)	3/32 (9.38%)
Renal and urinary disorders
URINARY INCONTINENCE † 1	2/29 (6.90%)	0/32 (0.00%)
HAEMATURIA † 1	0/29 (0.00%)	3/32 (9.38%)
Reproductive system and breast disorders
OVARIAN DISORDER † 1	3/29 (10.34%)	0/32 (0.00%)
Respiratory, thoracic and mediastinal disorders
COUGHING † 1	0/29 (0.00%)	2/32 (6.25%)
PHARYNGITIS † 1	7/29 (24.14%)	9/32 (28.13%)
PNEUMONIA † 1	1/29 (3.45%)	2/32 (6.25%)
RHINITIS † 1	8/29 (27.59%)	12/32 (37.50%)
SINUSITIS † 1	5/29 (17.24%)	4/32 (12.50%)
UPPER RESP TRACT INFECTION † 1	25/29 (86.21%)	28/32 (87.50%)
BRONCHITIS † 1	9/29 (31.03%)	10/32 (31.25%)
ASTHMA † 1	6/29 (20.69%)	6/32 (18.75%)
Skin and subcutaneous tissue disorders
ACNE † 1	2/29 (6.90%)	3/32 (9.38%)
DERMATITIS † 1	3/29 (10.34%)	2/32 (6.25%)
ECZEMA † 1	6/29 (20.69%)	5/32 (15.63%)
PRURITUS † 1	0/29 (0.00%)	2/32 (6.25%)
RASH † 1	3/29 (10.34%)	1/32 (3.13%)
RASH ERYTHEMATOUS † 1	2/29 (6.90%)	1/32 (3.13%)
RASH PUSTULAR † 1	4/29 (13.79%)	2/32 (6.25%)
SKIN DISORDER † 1	3/29 (10.34%)	1/32 (3.13%)
URTICARIA † 1	2/29 (6.90%)	2/32 (6.25%)
DERMATITIS CONTACT † 1	0/29 (0.00%)	2/32 (6.25%)
OTITIS EXTERNA † 1	3/29 (10.34%)	2/32 (6.25%)
BULLOUS ERUPTION † 1	2/29 (6.90%)	2/32 (6.25%)
VERRUCA † 1	1/29 (3.45%)	4/32 (12.50%)
† Indicates events were collected by systematic assessment; 1 Term from vocabulary, WHO-ART, 2001(014)

Limitations and Caveats

[Not Specified]

More Information

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.

Restriction Description: Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

Results Point of Contact

• Name/Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.
• Phone: 1-800-718-1021
• EMail: ClinicalTrials.gov_Inquiries@pfizer.com

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT01859949
• Other Study ID Numbers: GENASG-0021-007; A6281225 ( Other Identifier: Alias Study Number ); 2015-004552-21 ( EudraCT Number )
• First Submitted: April 17, 2013
• First Posted: May 22, 2013
• Results First Submitted: February 16, 2016
• Results First Posted: March 15, 2016
• Last Update Posted: May 3, 2016