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Trial record 1 of 1 for:    A6281225
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Long Term Study of Genotropin (Somatropin) for Short Children Born Small for Gestational Age (SGA)

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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:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design 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
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
Hide 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
Arm/Group Title Dose-Increasing Group Dose-Remaining Group Total
Hide 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
Hide 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%
1.Primary Outcome
Title Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description [Not Specified]
Time Frame Month 12 (at the end of previous study) to 156
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide Description Height velocity is the yearly height gain
Time Frame Month 12 (at the end of previous study) to 156
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dose-Increasing Group Dose-Remainig Group
Hide 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   --/--   --/-- 
Show Serious Adverse Events Hide 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)
Show Other (Not Including Serious) Adverse Events Hide 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)
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
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01859949     History of Changes
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