Trial Outcomes & Findings for Genotropin Treatment In Very Young Children Born Small For Gestational Age (NCT NCT00627523)

Last Updated: 2014-11-04

Results Overview

Height SDS was calculated at the relevant visit by means of the following formula: Height SDS = (participant height) - (normal height)/normal height standard deviation. Where participant height refers to the participant's height at the relevant visit, and normal height and the normal height standard deviation equals the population mean and standard deviation values for participants of a similar age and gender. The change from Baseline value for height SDS was calculated as the difference between the parameter values at a specific visit, and the Baseline parameter values. The scores were centred around zero. Negative score indicated a participant was smaller for their age/gender.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

43 participants

Primary outcome timeframe

Baseline and Month 24

Results posted on

2014-11-04

Participant Flow

This randomized controlled trial enrolled small for gestational age (SGA) children at 16 centers in 8 countries. In total, 52 participants were screened for the study, of these, 9 participants were considered screen failures. The remaining 43 participants were randomized to receive either study drug (Genotropin®) or were not treated (Control).

Participants aged between 19 to 29 months at Screening visit, born SGA (birth length and/or weight \<-2 standard deviations (SD) for gestational age, using country-specific standards), height below -2.5 SD at Screening (19-29 months of age), and had at least one measurement of length between 12 and 18 months of age were enrolled in this study.

Participant milestones

Participant milestones
Measure	Genotropin® Participants received Genotropin® at a dose of 0.035 mg/kg/d for 24 months. The dose was calculated based on the actual body weight, and the closest dosing step of the 5 mg pen used. The starting dose for the first 2 weeks was 1/3 of the calculated dose. After 2 weeks the dose was increased to 2/3 of the calculated dose. After 4 weeks the daily dose was the dose calculated on body weight at randomization.	Control This group was the untreated control group and was not administered placebo.
Overall Study STARTED	21	22
Overall Study COMPLETED	19	20
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Genotropin® Participants received Genotropin® at a dose of 0.035 mg/kg/d for 24 months. The dose was calculated based on the actual body weight, and the closest dosing step of the 5 mg pen used. The starting dose for the first 2 weeks was 1/3 of the calculated dose. After 2 weeks the dose was increased to 2/3 of the calculated dose. After 4 weeks the daily dose was the dose calculated on body weight at randomization.	Control This group was the untreated control group and was not administered placebo.
Overall Study Lack of Efficacy	1	0
Overall Study Withdrawal by Subject	0	2
Overall Study Other	1	0

Baseline Characteristics

Genotropin Treatment In Very Young Children Born Small For Gestational Age

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Genotropin® n=21 Participants Participants received Genotropin® at a dose of 0.035 mg/kg/d for 24 months. The dose was calculated based on the actual body weight, and the closest dosing step of the 5 mg pen used. The starting dose for the first 2 weeks was 1/3 of the calculated dose. After 2 weeks the dose was increased to 2/3 of the calculated dose. After 4 weeks the daily dose was the dose calculated on body weight at randomization.	Control n=22 Participants This group was the untreated control group and was not administered placebo.	Total n=43 Participants Total of all reporting groups
Age, Continuous	24.91 Months STANDARD_DEVIATION 3.262 • n=5 Participants	24.44 Months STANDARD_DEVIATION 3.324 • n=7 Participants	24.67 Months STANDARD_DEVIATION 3.263 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	11 Participants n=7 Participants	24 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	11 Participants n=7 Participants	19 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Month 24

Population: Full Analysis Set (FAS) included participants who were randomized to treatment and completed at least one post-baseline efficacy measure. Missing values were imputed using LOCF method. One participant was randomized to Genotropin® but did not receive any treatment. This participant was excluded from FAS but included in Control for safety analysis.

Outcome measures

Outcome measures
Measure	Genotropin® n=21 Participants Participants received Genotropin® at a dose of 0.035 mg/kg/d for 24 months. The dose was calculated based on the actual body weight, and the closest dosing step of the 5 mg pen used. The starting dose for the first 2 weeks was 1/3 of the calculated dose. After 2 weeks the dose was increased to 2/3 of the calculated dose. After 4 weeks the daily dose was the dose calculated on body weight at randomization.	Control n=21 Participants This group was the untreated control group and was not administered placebo.
Change From Baseline in Height Standard Deviation Score (SDS) at Month 24.	1.63 SDS Standard Error 0.13	0.43 SDS Standard Error 0.13

SECONDARY outcome

Timeframe: Baseline and Month 24

The growth velocity SDS was calculated at the relevant visit by means of the following formula: Growth velocity SDS = (participant growth velocity) - (normal growth velocity)/normal growth velocity standard deviation. Where, participant growth velocity refers to the participant's growth velocity at the relevant visit, and normal growth velocity and the normal growth velocity standard deviation equals the population mean and standard deviation values for participants of a similar age and gender. The change from Baseline value for growth velocity SDS was calculated as the difference between the parameter values at a specific visit, and the Baseline parameter values. A negative score indicated that a participant had slower growth for their age/gender.

Outcome measures

Outcome measures
Measure	Genotropin® n=21 Participants Participants received Genotropin® at a dose of 0.035 mg/kg/d for 24 months. The dose was calculated based on the actual body weight, and the closest dosing step of the 5 mg pen used. The starting dose for the first 2 weeks was 1/3 of the calculated dose. After 2 weeks the dose was increased to 2/3 of the calculated dose. After 4 weeks the daily dose was the dose calculated on body weight at randomization.	Control n=21 Participants This group was the untreated control group and was not administered placebo.
Change From Baseline in Growth Velocity SDS at Month 24.	0.74 SDS Standard Error 0.57	-0.03 SDS Standard Error 0.57

SECONDARY outcome

Timeframe: Baseline and Month 12

Outcome measures

Outcome measures
Measure	Genotropin® n=21 Participants Participants received Genotropin® at a dose of 0.035 mg/kg/d for 24 months. The dose was calculated based on the actual body weight, and the closest dosing step of the 5 mg pen used. The starting dose for the first 2 weeks was 1/3 of the calculated dose. After 2 weeks the dose was increased to 2/3 of the calculated dose. After 4 weeks the daily dose was the dose calculated on body weight at randomization.	Control n=21 Participants This group was the untreated control group and was not administered placebo.
Change From Baseline in Height SDS at Month 12.	1.03 SDS Standard Error 0.12	0.14 SDS Standard Error 0.12

SECONDARY outcome

Timeframe: Baseline and Month 12

Outcome measures

Outcome measures
Measure	Genotropin® n=21 Participants Participants received Genotropin® at a dose of 0.035 mg/kg/d for 24 months. The dose was calculated based on the actual body weight, and the closest dosing step of the 5 mg pen used. The starting dose for the first 2 weeks was 1/3 of the calculated dose. After 2 weeks the dose was increased to 2/3 of the calculated dose. After 4 weeks the daily dose was the dose calculated on body weight at randomization.	Control n=21 Participants This group was the untreated control group and was not administered placebo.
Change From Baseline in Growth Velocity SDS at Month 12.	1.65 SDS Standard Error 0.56	-1.59 SDS Standard Error 0.56

SECONDARY outcome

Timeframe: Baseline and Month 12

Population: Full Analysis Set (FAS) included participants who were randomized to treatment and completed at least one post-baseline efficacy measure. One participant was randomized to Genotropin® but did not receive any treatment. This participant was excluded from FAS but included in Control group for safety analysis.

The Bayley Scale of Infant Development (BSID-II) measured the mental and psychomotor development and test behavior of participants from 1 to 42 months of age. The scale was used to describe the current developmental functioning of infants and to assist in diagnosis and treatment planning for infants with developmental delays or disabilities. The BSID-II provided the mental raw score which was used to calculate the MDI score. Possible MDI scores ranged from 50-150. A score of 69 and below indicates significantly delayed performance, 70 to 84 indicates mildly delayed performance, 85 to 114 indicates normal limits and 115 and above indicates accelerated performance.

Outcome measures

Outcome measures
Measure	Genotropin® n=21 Participants Participants received Genotropin® at a dose of 0.035 mg/kg/d for 24 months. The dose was calculated based on the actual body weight, and the closest dosing step of the 5 mg pen used. The starting dose for the first 2 weeks was 1/3 of the calculated dose. After 2 weeks the dose was increased to 2/3 of the calculated dose. After 4 weeks the daily dose was the dose calculated on body weight at randomization.	Control n=21 Participants This group was the untreated control group and was not administered placebo.
Change From Baseline in Mental Development Using the Mental Development Index (MDI) of Bayley Scale at Month 12.	10.97 Units on a scale Standard Error 5.34	8.55 Units on a scale Standard Error 4.74

SECONDARY outcome

Timeframe: Baseline and Month 12

BSID-II measured the mental and psychomotor development and test behavior of participants from 1 to 42 months of age. The scale was used to describe the current developmental functioning of infants and to assist in diagnosis and treatment planning for infants with developmental delays or disabilities. The BSID-II provided the psychomotor raw score which was used to calculate the PDI score. Possible PDI scores ranged from 50-150. A score of 69 and below indicates significantly delayed performance, 70 to 84 indicates mildly delayed performance, 85 to 114 indicates normal limits and 115 and above indicates accelerated performance.

Outcome measures

Outcome measures
Measure	Genotropin® n=21 Participants Participants received Genotropin® at a dose of 0.035 mg/kg/d for 24 months. The dose was calculated based on the actual body weight, and the closest dosing step of the 5 mg pen used. The starting dose for the first 2 weeks was 1/3 of the calculated dose. After 2 weeks the dose was increased to 2/3 of the calculated dose. After 4 weeks the daily dose was the dose calculated on body weight at randomization.	Control n=21 Participants This group was the untreated control group and was not administered placebo.
Change From Baseline in Psychomotor Development Using the Psychomotor Development Index (PDI) of Bayley Scale at Month 12.	4.04 Units on a scale Standard Error 3.04	8.55 Units on a scale Standard Error 2.84

SECONDARY outcome

Timeframe: Months 3, 6, 12, 18 and 24

Head circumference SDS was calculated by means of the following formula = (Participant head circumference)-(Normal head circumference)/ Normal head circumference standard deviation. Where participant head circumference refers to the participant's head circumference at the relevant visit, and normal head circumference and the normal head circumference standard deviation equals the population mean and standard deviation values for participants of a similar age and gender. A negative score indicated a participant had a smaller head circumference for their age/gender.

Outcome measures

Outcome measures
Measure	Genotropin® n=21 Participants Participants received Genotropin® at a dose of 0.035 mg/kg/d for 24 months. The dose was calculated based on the actual body weight, and the closest dosing step of the 5 mg pen used. The starting dose for the first 2 weeks was 1/3 of the calculated dose. After 2 weeks the dose was increased to 2/3 of the calculated dose. After 4 weeks the daily dose was the dose calculated on body weight at randomization.	Control n=21 Participants This group was the untreated control group and was not administered placebo.
Head Circumference SDS at Months 3, 6, 12, 18 and 24. Month 3 (n = 21, 19)	-0.93 SDS Standard Deviation 1.217	-1.37 SDS Standard Deviation 1.122
Head Circumference SDS at Months 3, 6, 12, 18 and 24. Month 6 (n = 21, 19)	-1.20 SDS Standard Deviation 1.310	-1.72 SDS Standard Deviation 1.077
Head Circumference SDS at Months 3, 6, 12, 18 and 24. Month 12 (n = 20, 18)	-0.87 SDS Standard Deviation 1.330	-1.84 SDS Standard Deviation 1.158
Head Circumference SDS at Months 3, 6, 12, 18 and 24. Month 18 (n = 20, 19)	-0.56 SDS Standard Deviation 1.890	-1.76 SDS Standard Deviation 1.153
Head Circumference SDS at Months 3, 6, 12, 18 and 24. Month 24 (n = 20, 20)	-0.75 SDS Standard Deviation 1.384	-1.65 SDS Standard Deviation 1.227

SECONDARY outcome

Timeframe: Baseline, Months 3, 6, 12, 18 and 24.

Head circumference SDS was calculated by means of the following formula = (Participant head circumference)-(Normal head circumference)/Normal head circumference standard deviation. Where participant head circumference refers to the participant's head circumference at the relevant visit, and normal head circumference and the normal head circumference standard deviation equals the population mean and standard deviation values for participants of a similar age and gender. A negative score indicated a participant had a smaller head circumference for their age/gender.

Outcome measures

Outcome measures
Measure	Genotropin® n=21 Participants Participants received Genotropin® at a dose of 0.035 mg/kg/d for 24 months. The dose was calculated based on the actual body weight, and the closest dosing step of the 5 mg pen used. The starting dose for the first 2 weeks was 1/3 of the calculated dose. After 2 weeks the dose was increased to 2/3 of the calculated dose. After 4 weeks the daily dose was the dose calculated on body weight at randomization.	Control n=21 Participants This group was the untreated control group and was not administered placebo.
Change From Baseline in Head Circumference SDS at Months 3, 6, 12, 18 and 24. Month 3 (n = 21, 19)	0.27 SDS Standard Deviation 0.977	0.36 SDS Standard Deviation 0.693
Change From Baseline in Head Circumference SDS at Months 3, 6, 12, 18 and 24. Month 6 (n = 21, 19)	-0.00 SDS Standard Deviation 0.423	0.07 SDS Standard Deviation 0.495
Change From Baseline in Head Circumference SDS at Months 3, 6, 12, 18 and 24. Month 12 (n = 20, 18)	0.26 SDS Standard Deviation 0.516	0.02 SDS Standard Deviation 0.587
Change From Baseline in Head Circumference SDS at Months 3, 6, 12, 18 and 24. Month 18 (n = 20, 19)	0.57 SDS Standard Deviation 1.094	0.04 SDS Standard Deviation 0.506
Change From Baseline in Head Circumference SDS at Months 3, 6, 12, 18 and 24. Month 24 (n = 20, 20)	0.39 SDS Standard Deviation 0.638	0.08 SDS Standard Deviation 0.602

SECONDARY outcome

Timeframe: Baseline, Months 3, 6, 12, 18, and 24

Body weight was measured at all the relevant visits. The change from Baseline in body weight was calculated as the difference between the parameter values at each visit, and the Baseline parameter values.

Outcome measures

Outcome measures
Measure	Genotropin® n=21 Participants Participants received Genotropin® at a dose of 0.035 mg/kg/d for 24 months. The dose was calculated based on the actual body weight, and the closest dosing step of the 5 mg pen used. The starting dose for the first 2 weeks was 1/3 of the calculated dose. After 2 weeks the dose was increased to 2/3 of the calculated dose. After 4 weeks the daily dose was the dose calculated on body weight at randomization.	Control n=21 Participants This group was the untreated control group and was not administered placebo.
Change From Baseline in Body Weight at Months 3, 6, 12, 18, and 24. Month 3 (n = 21, 19)	0.57 Kg Standard Deviation 0.154	0.53 Kg Standard Deviation 0.406
Change From Baseline in Body Weight at Months 3, 6, 12, 18, and 24. Month 6 (n = 21, 20)	1.08 Kg Standard Deviation 0.269	1.01 Kg Standard Deviation 0.659
Change From Baseline in Body Weight at Months 3, 6, 12, 18, and 24. Month 12 (n = 20, 19)	2.34 Kg Standard Deviation 0.389	1.66 Kg Standard Deviation 0.397
Change From Baseline in Body Weight at Months 3, 6, 12, 18, and 24. Month 18 (n = 20, 19)	3.48 Kg Standard Deviation 0.669	2.41 Kg Standard Deviation 0.709
Change From Baseline in Body Weight at Months 3, 6, 12, 18, and 24. Month 24 (n = 20, 20)	4.79 Kg Standard Deviation 0.814	3.19 Kg Standard Deviation 0.601

SECONDARY outcome

Timeframe: Baseline, Months 3, 6, 12, 18, and 24

Body mass index was calculated for all visits by means of the following formula: BMI (kg/m2) = Weight (kg)/(Height\[m\])2. The change from Baseline BMI was calculated as the difference between the parameter values at each visit, and the Baseline parameter values.

Outcome measures

Outcome measures
Measure	Genotropin® n=21 Participants Participants received Genotropin® at a dose of 0.035 mg/kg/d for 24 months. The dose was calculated based on the actual body weight, and the closest dosing step of the 5 mg pen used. The starting dose for the first 2 weeks was 1/3 of the calculated dose. After 2 weeks the dose was increased to 2/3 of the calculated dose. After 4 weeks the daily dose was the dose calculated on body weight at randomization.	Control n=21 Participants This group was the untreated control group and was not administered placebo.
Change From Baseline in Body Mass Index (BMI) at Months 3, 6, 12, 18, and 24. Month 3 (n = 21, 19)	-0.28 Kg/m2 Standard Deviation 0.419	-0.05 Kg/m2 Standard Deviation 0.811
Change From Baseline in Body Mass Index (BMI) at Months 3, 6, 12, 18, and 24. Month 6 (n = 21, 20)	-0.57 Kg/m2 Standard Deviation 0.537	0.08 Kg/m2 Standard Deviation 1.013
Change From Baseline in Body Mass Index (BMI) at Months 3, 6, 12, 18, and 24. Month 12 (n = 20, 19)	-0.62 Kg/m2 Standard Deviation 0.650	-0.29 Kg/m2 Standard Deviation 0.683
Change From Baseline in Body Mass Index (BMI) at Months 3, 6, 12, 18, and 24. Month 18 (n = 20, 19)	-0.78 Kg/m2 Standard Deviation 0.930	-0.25 Kg/m2 Standard Deviation 0.806
Change From Baseline in Body Mass Index (BMI) at Months 3, 6, 12, 18, and 24. Month 24 (n = 20, 20)	-0.58 Kg/m2 Standard Deviation 0.823	-0.55 Kg/m2 Standard Deviation 0.776

Adverse Events

Genotropin®

Serious events: 6 serious events

Other events: 21 other events

Deaths: 0 deaths

Control

Serious events: 2 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Genotropin® n=21 participants at risk Participants received Genotropin® at a dose of 0.035 mg/kg/d for 24 months. The dose was calculated based on the actual body weight, and the closest dosing step of the 5 mg pen used. The starting dose for the first 2 weeks was 1/3 of the calculated dose. After 2 weeks the dose was increased to 2/3 of the calculated dose. After 4 weeks the daily dose was the dose calculated on body weight at randomization.	Control n=22 participants at risk This group was the untreated control group and was not administered placebo.
Ear and labyrinth disorders Conductive deafness	9.5% 2/21 • Up to the participant's age of 49 to 55 months (Follow-up visit) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/22 • Up to the participant's age of 49 to 55 months (Follow-up visit) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Bronchopneumonia	4.8% 1/21 • Up to the participant's age of 49 to 55 months (Follow-up visit) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/22 • Up to the participant's age of 49 to 55 months (Follow-up visit) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Gastroenteritis	4.8% 1/21 • Up to the participant's age of 49 to 55 months (Follow-up visit) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	4.5% 1/22 • Up to the participant's age of 49 to 55 months (Follow-up visit) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Hordeolum	4.8% 1/21 • Up to the participant's age of 49 to 55 months (Follow-up visit) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/22 • Up to the participant's age of 49 to 55 months (Follow-up visit) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Rotavirus infection	0.00% 0/21 • Up to the participant's age of 49 to 55 months (Follow-up visit) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	4.5% 1/22 • Up to the participant's age of 49 to 55 months (Follow-up visit) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Viral infection	4.8% 1/21 • Up to the participant's age of 49 to 55 months (Follow-up visit) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/22 • Up to the participant's age of 49 to 55 months (Follow-up visit) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Concussion	4.8% 1/21 • Up to the participant's age of 49 to 55 months (Follow-up visit) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/22 • Up to the participant's age of 49 to 55 months (Follow-up visit) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Dehydration	4.8% 1/21 • Up to the participant's age of 49 to 55 months (Follow-up visit) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/22 • Up to the participant's age of 49 to 55 months (Follow-up visit) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Adenoidal hypertrophy	4.8% 1/21 • Up to the participant's age of 49 to 55 months (Follow-up visit) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/22 • Up to the participant's age of 49 to 55 months (Follow-up visit) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Asthma	4.8% 1/21 • Up to the participant's age of 49 to 55 months (Follow-up visit) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/22 • Up to the participant's age of 49 to 55 months (Follow-up visit) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Tonsillar hypertrophy	4.8% 1/21 • Up to the participant's age of 49 to 55 months (Follow-up visit) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/22 • Up to the participant's age of 49 to 55 months (Follow-up visit) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.

Other adverse events

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER