Trial Outcomes & Findings for Special Investigation Of Genotropin Long Follow-Up For Patients With A Small For Gestational Age "Scoped for Japanese" (NCT NCT01897766)

Last Updated: 2023-09-25

Results Overview

An adverse drug reaction (ADR) was any untoward medical occurrence attributed to Genotropin in a participant who received Genotropin. A serious ADR (SADR) was an ADR resulting in any of the following out comes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to Genotropin was assessed by the physician.

Recruitment status

COMPLETED

Target enrollment

482 participants

Primary outcome timeframe

Approximately 11.58 years

Results posted on

2023-09-25

Participant Flow

It is a retrospective study. Data was collected for participants from July 2005 - February 2017(approximately over 11 years 6 months).

Participant milestones

Participant milestones
Measure	Genotropin [Somatropin (Genetical Recombination)] Participants who received Genotropin treatment in a real world clinic setting as prescribed in clinical practice from July 2005 - February 2017. Data was observed retrospectively.
Overall Study STARTED	482
Overall Study COMPLETED	482
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Genotropin [Somatropin (Genetical Recombination)] n=482 Participants Participants who received Genotropin treatment in a real world clinic setting as prescribed in clinical practice from July 2005 - February 2017. Data was observed retrospectively.
Age, Customized <5 years	220 Participants n=482 Participants
Age, Customized ≥5 and <7 years	95 Participants n=482 Participants
Age, Customized ≥7 years	167 Participants n=482 Participants
Sex/Gender, Customized Male	240 Participants n=482 Participants
Sex/Gender, Customized Female	242 Participants n=482 Participants

PRIMARY outcome

Timeframe: Approximately 11.58 years

Population: The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Genotropin.

Outcome measures

Outcome measures
Measure	Genotropin [Somatropin (Genetical Recombination)] n=482 Participants Participants who received Genotropin treatment in a real world clinic setting as prescribed in clinical practice from July 2005 - February 2017. Data was observed retrospectively.
Number of Participants With Adverse Drug Reaction (ADR) ADR	24 Participants
Number of Participants With Adverse Drug Reaction (ADR) SADR	4 Participants

PRIMARY outcome

Timeframe: Baseline, Year 1

Population: The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation at least once. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

Change in height Velocity SD score from baseline was calculated. Height Velocity SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.

Outcome measures

Outcome measures
Measure	Genotropin [Somatropin (Genetical Recombination)] n=324 Participants Participants who received Genotropin treatment in a real world clinic setting as prescribed in clinical practice from July 2005 - February 2017. Data was observed retrospectively.
Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline At Year 1	4.1 SD score Standard Deviation 3.06

PRIMARY outcome

Timeframe: Baseline, Year 2

Outcome measures

Outcome measures
Measure	Genotropin [Somatropin (Genetical Recombination)] n=243 Participants Participants who received Genotropin treatment in a real world clinic setting as prescribed in clinical practice from July 2005 - February 2017. Data was observed retrospectively.
Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 2	3.0 SD score Standard Deviation 2.92

PRIMARY outcome

Timeframe: Baseline, Year 3

Outcome measures

Outcome measures
Measure	Genotropin [Somatropin (Genetical Recombination)] n=169 Participants Participants who received Genotropin treatment in a real world clinic setting as prescribed in clinical practice from July 2005 - February 2017. Data was observed retrospectively.
Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 3	2.5 SD score Standard Deviation 2.53

PRIMARY outcome

Timeframe: Baseline, Year 4

Outcome measures

Outcome measures
Measure	Genotropin [Somatropin (Genetical Recombination)] n=146 Participants Participants who received Genotropin treatment in a real world clinic setting as prescribed in clinical practice from July 2005 - February 2017. Data was observed retrospectively.
Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 4	2.6 SD score Standard Deviation 2.81

PRIMARY outcome

Timeframe: Baseline, Year 5

Outcome measures

Outcome measures
Measure	Genotropin [Somatropin (Genetical Recombination)] n=137 Participants Participants who received Genotropin treatment in a real world clinic setting as prescribed in clinical practice from July 2005 - February 2017. Data was observed retrospectively.
Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 5	2.3 SD score Standard Deviation 2.74

PRIMARY outcome

Timeframe: Baseline, Year 6

Outcome measures

Outcome measures
Measure	Genotropin [Somatropin (Genetical Recombination)] n=101 Participants Participants who received Genotropin treatment in a real world clinic setting as prescribed in clinical practice from July 2005 - February 2017. Data was observed retrospectively.
Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 6	2.4 SD score Standard Deviation 3.07

PRIMARY outcome

Timeframe: Baseline, Year 7

Outcome measures

Outcome measures
Measure	Genotropin [Somatropin (Genetical Recombination)] n=51 Participants Participants who received Genotropin treatment in a real world clinic setting as prescribed in clinical practice from July 2005 - February 2017. Data was observed retrospectively.
Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 7	2.4 SD score Standard Deviation 3.86

PRIMARY outcome

Timeframe: Baseline, Year 10

Outcome measures

Outcome measures
Measure	Genotropin [Somatropin (Genetical Recombination)] n=1 Participants Participants who received Genotropin treatment in a real world clinic setting as prescribed in clinical practice from July 2005 - February 2017. Data was observed retrospectively.
Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 10	-1.6 SD score Standard Deviation NA Only 1 subject evaluable hence standard deviation could not be estimated.

PRIMARY outcome

Timeframe: Baseline, Year 1

Outcome measures

Outcome measures
Measure	Genotropin [Somatropin (Genetical Recombination)] n=388 Participants Participants who received Genotropin treatment in a real world clinic setting as prescribed in clinical practice from July 2005 - February 2017. Data was observed retrospectively.
Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 1	0.6 SD score Standard Deviation 0.36

PRIMARY outcome

Timeframe: Baseline, Year 2

Outcome measures

Outcome measures
Measure	Genotropin [Somatropin (Genetical Recombination)] n=315 Participants Participants who received Genotropin treatment in a real world clinic setting as prescribed in clinical practice from July 2005 - February 2017. Data was observed retrospectively.
Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 2	0.9 SD score Standard Deviation 0.49

PRIMARY outcome

Timeframe: Baseline, Year 3

Outcome measures

Outcome measures
Measure	Genotropin [Somatropin (Genetical Recombination)] n=233 Participants Participants who received Genotropin treatment in a real world clinic setting as prescribed in clinical practice from July 2005 - February 2017. Data was observed retrospectively.
Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 3	1.1 SD score Standard Deviation 0.51

PRIMARY outcome

Timeframe: Baseline, Year 4

Outcome measures

Outcome measures
Measure	Genotropin [Somatropin (Genetical Recombination)] n=223 Participants Participants who received Genotropin treatment in a real world clinic setting as prescribed in clinical practice from July 2005 - February 2017. Data was observed retrospectively.
Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 4	1.3 SD score Standard Deviation 0.63

PRIMARY outcome

Timeframe: Baseline, Year 5

Outcome measures

Outcome measures
Measure	Genotropin [Somatropin (Genetical Recombination)] n=205 Participants Participants who received Genotropin treatment in a real world clinic setting as prescribed in clinical practice from July 2005 - February 2017. Data was observed retrospectively.
Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 5	1.3 SD score Standard Deviation 0.71

PRIMARY outcome

Timeframe: Baseline, Year 6

Outcome measures

Outcome measures
Measure	Genotropin [Somatropin (Genetical Recombination)] n=136 Participants Participants who received Genotropin treatment in a real world clinic setting as prescribed in clinical practice from July 2005 - February 2017. Data was observed retrospectively.
Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 6	1.4 SD score Standard Deviation 0.81

PRIMARY outcome

Timeframe: Baseline, Year 7

Outcome measures

Outcome measures
Measure	Genotropin [Somatropin (Genetical Recombination)] n=72 Participants Participants who received Genotropin treatment in a real world clinic setting as prescribed in clinical practice from July 2005 - February 2017. Data was observed retrospectively.
Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 7	1.4 SD score Standard Deviation 0.87

PRIMARY outcome

Timeframe: Baseline, Year 9

Outcome measures

Outcome measures
Measure	Genotropin [Somatropin (Genetical Recombination)] n=1 Participants Participants who received Genotropin treatment in a real world clinic setting as prescribed in clinical practice from July 2005 - February 2017. Data was observed retrospectively.
Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 9	2.1 SD score Standard Deviation NA Only 1 subject evaluable hence standard deviation could not be estimated.

PRIMARY outcome

Timeframe: Baseline, Year 10

Outcome measures

Outcome measures
Measure	Genotropin [Somatropin (Genetical Recombination)] n=1 Participants Participants who received Genotropin treatment in a real world clinic setting as prescribed in clinical practice from July 2005 - February 2017. Data was observed retrospectively.
Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 10	1.8 SD score Standard Deviation NA Only 1 subject evaluable hence standard deviation could not be estimated.

SECONDARY outcome

Timeframe: Baseline, At Puberty, At Near Final Height within the span of approximately maximum of 11.58 years

Population: The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation at least once. Among the efficacy analysis set, the participants who reached near final height was analyzed.

Height SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population. Near final height was defined as the height at one of the following conditions: the annual height velocity became less than 2 cm/year after reaching the maximum height in puberty, bone age reached 17 years old and older for male and 15 years old and older for female, or the reason for discontinuation was that subject reached the near final height or had epiphyseal closure.

Outcome measures

Outcome measures
Measure	Genotropin [Somatropin (Genetical Recombination)] n=34 Participants Participants who received Genotropin treatment in a real world clinic setting as prescribed in clinical practice from July 2005 - February 2017. Data was observed retrospectively.
Height Standard Deviation (SD) Score at Puberty and at Near Final Height in Participants Who Reached Near Final Height At puberty	-2.8 SD score Standard Deviation 0.86
Height Standard Deviation (SD) Score at Puberty and at Near Final Height in Participants Who Reached Near Final Height At near final height	-2.5 SD score Standard Deviation 1.16
Height Standard Deviation (SD) Score at Puberty and at Near Final Height in Participants Who Reached Near Final Height At baseline	-3.1 SD score Standard Deviation 0.77

SECONDARY outcome

Timeframe: Baseline, At Puberty, At Near Final Height within the span of approximately maximum of 11.58 years

Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population. Near final height was defined as the height at one of the following conditions: the annual height velocity became less than 2 cm/year after reaching the maximum height in puberty, bone age reached 17 years old and older for male and 15 years old and older for female, or the reason for discontinuation was that subject reached the near final height or had epiphyseal closure.

Outcome measures

Outcome measures
Measure	Genotropin [Somatropin (Genetical Recombination)] n=34 Participants Participants who received Genotropin treatment in a real world clinic setting as prescribed in clinical practice from July 2005 - February 2017. Data was observed retrospectively.
Change in Height Standard Deviation (SD) Score at Puberty and at Near Final Height in Participants Who Reached Near Final Height From Baseline Change At near final height	0.6 SD score Standard Deviation 0.74
Change in Height Standard Deviation (SD) Score at Puberty and at Near Final Height in Participants Who Reached Near Final Height From Baseline Change at At puberty	0.3 SD score Standard Deviation 0.36

Adverse Events

Genotropin [Somatropin (Genetical Recombination)]

Serious events: 32 serious events

Other events: 105 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Genotropin [Somatropin (Genetical Recombination)] n=482 participants at risk Participants who received Genotropin treatment in a real world clinic setting as prescribed in clinical practice from July 2005 - February 2017. Data was observed retrospectively.
Infections and infestations Acute sinusitis	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Infections and infestations Appendicitis	0.41% 2/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Infections and infestations Bronchitis	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Infections and infestations Campylobacter gastroenteritis	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Infections and infestations Gastroenteritis	0.41% 2/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Infections and infestations Meningitis bacterial	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Infections and infestations Otitis media	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Infections and infestations Pneumonia	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bone neoplasm	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Nervous system disorders Febrile convulsion	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Nervous system disorders Seizure	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Cardiac disorders Cardiac disorder	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Vascular disorders Kawasaki's disease	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Respiratory, thoracic and mediastinal disorders Asthma	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Respiratory, thoracic and mediastinal disorders Upper respiratory tract inflammation	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Skin and subcutaneous tissue disorders Henoch-Schonlein purpura	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Musculoskeletal and connective tissue disorders Osteochondrosis	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Musculoskeletal and connective tissue disorders Scoliosis	0.83% 4/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Musculoskeletal and connective tissue disorders Synovial disorder	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Congenital, familial and genetic disorders Cryptorchism	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
General disorders Condition aggravated	0.41% 2/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Injury, poisoning and procedural complications Patella fracture	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Injury, poisoning and procedural complications Snake bite	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Injury, poisoning and procedural complications Subdural haematoma	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.

Other adverse events

Other adverse events
Measure	Genotropin [Somatropin (Genetical Recombination)] n=482 participants at risk Participants who received Genotropin treatment in a real world clinic setting as prescribed in clinical practice from July 2005 - February 2017. Data was observed retrospectively.
Blood and lymphatic system disorders Lymphadenitis	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Cardiac disorders Sinus tachycardia	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Congenital, familial and genetic disorders Arnold-Chiari malformation	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Congenital, familial and genetic disorders Spine malformation	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Endocrine disorders Hyperthyroidism	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Endocrine disorders Hypothyroidism	0.41% 2/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Endocrine disorders Thyroiditis	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Eye disorders Conjunctivitis allergic	0.62% 3/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Gastrointestinal disorders Colitis	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Gastrointestinal disorders Constipation	0.83% 4/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Gastrointestinal disorders Pigmentation lip	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Gastrointestinal disorders Stomatitis	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
General disorders Injection site haemorrhage	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
General disorders Injection site urticaria	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
General disorders Pyrexia	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Hepatobiliary disorders Hepatic function abnormal	1.0% 5/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Immune system disorders Food allergy	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Immune system disorders Seasonal allergy	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Infections and infestations Adenoviral upper respiratory infection	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Infections and infestations Beta haemolytic streptococcal infection	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Infections and infestations Bronchitis	3.5% 17/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Infections and infestations Bronchitis viral	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Infections and infestations Dermatitis infected	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Infections and infestations Ear infection	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Infections and infestations Erythema infectiosum	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Infections and infestations Exanthema subitum	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Infections and infestations Gastroenteritis	2.5% 12/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Infections and infestations H1N1 influenza	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Infections and infestations Impetigo	0.62% 3/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Infections and infestations Influenza	2.9% 14/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Infections and infestations Molluscum contagiosum	0.41% 2/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Infections and infestations Nasopharyngitis	0.83% 4/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Infections and infestations Oral herpes	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Infections and infestations Otitis externa	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Infections and infestations Otitis media	1.5% 7/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Infections and infestations Otitis media acute	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Infections and infestations Parotitis	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Infections and infestations Pharyngitis	0.62% 3/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Infections and infestations Pneumonia	0.41% 2/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Infections and infestations Sinusitis	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Infections and infestations Streptococcal infection	0.41% 2/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Infections and infestations Subcutaneous abscess	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Infections and infestations Tonsillitis	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Infections and infestations Tracheobronchitis mycoplasmal	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Infections and infestations Varicella	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Injury, poisoning and procedural complications Contusion	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Injury, poisoning and procedural complications Fracture	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Injury, poisoning and procedural complications Meniscus injury	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Injury, poisoning and procedural complications Thermal burn	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Investigations Alanine aminotransferase increased	0.83% 4/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Investigations Aspartate aminotransferase increased	0.41% 2/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Investigations Blood alkaline phosphatase increased	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Investigations Blood cholesterol increased	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Investigations Blood glucose increased	0.41% 2/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Investigations Blood thyroid stimulating hormone decreased	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Investigations Blood thyroid stimulating hormone increased	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Investigations Blood urea increased	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Investigations Blood urine present	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Investigations Body mass index increased	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Investigations Glucose urine	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Investigations Glycosylated haemoglobin increased	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Investigations Insulin-like growth factor increased	0.41% 2/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Investigations Protein urine present	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Investigations White blood cell count increased	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Metabolism and nutrition disorders Glucose tolerance impaired	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Metabolism and nutrition disorders Hyperglycaemia	0.62% 3/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Metabolism and nutrition disorders Hyperinsulinaemia	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Metabolism and nutrition disorders Obesity	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Musculoskeletal and connective tissue disorders Arthralgia	0.83% 4/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Musculoskeletal and connective tissue disorders Arthropathy	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Musculoskeletal and connective tissue disorders Myalgia	0.41% 2/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Musculoskeletal and connective tissue disorders Scoliosis	0.41% 2/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neurofibroma	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Nervous system disorders Febrile convulsion	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Nervous system disorders Headache	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Nervous system disorders Orthostatic intolerance	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Nervous system disorders Seizure	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Psychiatric disorders Attention deficit/hyperactivity disorder	1.0% 5/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Psychiatric disorders Autism spectrum disorder	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Psychiatric disorders Depression	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Psychiatric disorders Tic	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Renal and urinary disorders Orthostatic proteinuria	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Renal and urinary disorders Proteinuria	0.41% 2/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Renal and urinary disorders Renal glycosuria	0.41% 2/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Renal and urinary disorders Renal haemorrhage	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Respiratory, thoracic and mediastinal disorders Asthma	2.3% 11/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	1.7% 8/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Respiratory, thoracic and mediastinal disorders Upper respiratory tract inflammation	3.5% 17/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Skin and subcutaneous tissue disorders Asteatosis	0.62% 3/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Skin and subcutaneous tissue disorders Blister	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Skin and subcutaneous tissue disorders Dermal cyst	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Skin and subcutaneous tissue disorders Dermatitis	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Skin and subcutaneous tissue disorders Dermatitis atopic	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Skin and subcutaneous tissue disorders Eczema	1.0% 5/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Skin and subcutaneous tissue disorders Eczema asteatotic	0.41% 2/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Skin and subcutaneous tissue disorders Pruritus	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Skin and subcutaneous tissue disorders Rash	0.62% 3/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Skin and subcutaneous tissue disorders Urticaria	0.41% 2/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Surgical and medical procedures Oral surgery	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Vascular disorders Hypertension	0.21% 1/482 • Approximately 11.58 years The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.

Additional Information

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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