Trial Outcomes & Findings for Observational Study of Somatropin Treatment in Children (NCT NCT01088412)
NCT ID: NCT01088412
Last Updated: 2019-05-13
Results Overview
Recruitment status
COMPLETED
Target enrollment
22845 participants
Primary outcome timeframe
Year 15
Results posted on
2019-05-13
Participant Flow
Participant milestones
| Measure |
Treated
Treatment with Humatrope for improvement of growth. Growth Hormone (GH) product.
|
Untreated
No treatment with Humatrope in participants with a history of neoplasia or in those with any short stature homeobox containing gene (SHOX) deficiency-related disorder .
|
Treatment with Humatrope unknown.
|
|---|---|---|---|
|
Overall Study
STARTED
|
22311
|
457
|
77
|
|
Overall Study
Safety Modified Evaluable (SME)
|
22294
|
456
|
0
|
|
Overall Study
SME With at Least 1 Follow Up (FU)
|
21178
|
306
|
0
|
|
Overall Study
SME+ >= 1 FU and Unknown Arm
|
21177
|
306
|
40
|
|
Overall Study
SME+ >= 1 FU and No Previous Cancer
|
20556
|
192
|
0
|
|
Overall Study
SME+ >= 1 FU and Previous Cancer
|
622
|
114
|
0
|
|
Overall Study
COMPLETED
|
4294
|
21
|
5
|
|
Overall Study
NOT COMPLETED
|
18017
|
436
|
72
|
Reasons for withdrawal
| Measure |
Treated
Treatment with Humatrope for improvement of growth. Growth Hormone (GH) product.
|
Untreated
No treatment with Humatrope in participants with a history of neoplasia or in those with any short stature homeobox containing gene (SHOX) deficiency-related disorder .
|
Treatment with Humatrope unknown.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
38
|
0
|
0
|
|
Overall Study
Death
|
42
|
6
|
0
|
|
Overall Study
Other Reason per Case Report Form
|
2089
|
103
|
9
|
|
Overall Study
Withdrawal by Subject
|
1761
|
25
|
1
|
|
Overall Study
Received Another GH Product
|
79
|
0
|
0
|
|
Overall Study
Participant Moved
|
601
|
21
|
2
|
|
Overall Study
Physician Decision
|
1041
|
8
|
4
|
|
Overall Study
Sponsor Decision
|
4467
|
79
|
23
|
|
Overall Study
Third Party Required to Change Brand
|
487
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
3052
|
130
|
11
|
|
Overall Study
Study Summary Not Completed
|
4360
|
64
|
22
|
Baseline Characteristics
Observational Study of Somatropin Treatment in Children
Baseline characteristics by cohort
| Measure |
Treated
n=22311 Participants
Treatment with Humatrope for improvement of growth.
|
Untreated
n=457 Participants
No treatment with Humatrope in participants with a history of neoplasia or in those with any SHOX deficiency-related disorder.
|
Unknown
n=77 Participants
Treatment with Humatrope unknown.
|
Total
n=22845 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
<=18 years
|
21724 participants
n=93 Participants
|
427 participants
n=4 Participants
|
27 participants
n=27 Participants
|
22178 participants
n=483 Participants
|
|
Age, Customized
Between 18 and 65 years
|
451 participants
n=93 Participants
|
20 participants
n=4 Participants
|
1 participants
n=27 Participants
|
472 participants
n=483 Participants
|
|
Age, Customized
>=65 years
|
0 participants
n=93 Participants
|
0 participants
n=4 Participants
|
0 participants
n=27 Participants
|
0 participants
n=483 Participants
|
|
Sex/Gender, Customized
Female
|
8917 participants
n=93 Participants
|
247 participants
n=4 Participants
|
11 participants
n=27 Participants
|
9175 participants
n=483 Participants
|
|
Sex/Gender, Customized
Male
|
13362 participants
n=93 Participants
|
209 participants
n=4 Participants
|
17 participants
n=27 Participants
|
13588 participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
959 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
977 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9279 Participants
n=93 Participants
|
166 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
9445 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
12073 Participants
n=93 Participants
|
273 Participants
n=4 Participants
|
77 Participants
n=27 Participants
|
12423 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
9 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
9 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
260 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
263 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
16 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
16 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
295 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
303 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
8328 Participants
n=93 Participants
|
148 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
8476 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
13403 Participants
n=93 Participants
|
298 Participants
n=4 Participants
|
77 Participants
n=27 Participants
|
13778 Participants
n=483 Participants
|
|
Region of Enrollment
Australia
|
87 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
87 Participants
n=483 Participants
|
|
Region of Enrollment
Austria
|
103 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
103 Participants
n=483 Participants
|
|
Region of Enrollment
Belgium
|
83 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
83 Participants
n=483 Participants
|
|
Region of Enrollment
Canada
|
850 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
870 Participants
n=483 Participants
|
|
Region of Enrollment
Czechia
|
332 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
344 Participants
n=483 Participants
|
|
Region of Enrollment
Denmark
|
5 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
|
Region of Enrollment
Finland
|
28 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
28 Participants
n=483 Participants
|
|
Region of Enrollment
France
|
1667 Participants
n=93 Participants
|
150 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
1821 Participants
n=483 Participants
|
|
Region of Enrollment
Germany
|
2685 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
2723 Participants
n=483 Participants
|
|
Region of Enrollment
Greece
|
290 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
305 Participants
n=483 Participants
|
|
Region of Enrollment
Hungary
|
332 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
334 Participants
n=483 Participants
|
|
Region of Enrollment
Iceland
|
48 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
48 Participants
n=483 Participants
|
|
Region of Enrollment
India
|
212 Participants
n=93 Participants
|
30 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
242 Participants
n=483 Participants
|
|
Region of Enrollment
Italy
|
771 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
788 Participants
n=483 Participants
|
|
Region of Enrollment
Japan
|
2352 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
2356 Participants
n=483 Participants
|
|
Region of Enrollment
Kazakhstan
|
29 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
29 Participants
n=483 Participants
|
|
Region of Enrollment
Lithuania
|
90 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
90 Participants
n=483 Participants
|
|
Region of Enrollment
Netherlands
|
317 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
320 Participants
n=483 Participants
|
|
Region of Enrollment
Norway
|
8 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
8 Participants
n=483 Participants
|
|
Region of Enrollment
Pakistan
|
172 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
178 Participants
n=483 Participants
|
|
Region of Enrollment
Russia
|
180 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
195 Participants
n=483 Participants
|
|
Region of Enrollment
Singapore
|
13 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
16 Participants
n=483 Participants
|
|
Region of Enrollment
Slovakia
|
94 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
94 Participants
n=483 Participants
|
|
Region of Enrollment
South Africa
|
106 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
109 Participants
n=483 Participants
|
|
Region of Enrollment
Spain
|
1404 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
1422 Participants
n=483 Participants
|
|
Region of Enrollment
Sweden
|
53 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
53 Participants
n=483 Participants
|
|
Region of Enrollment
Taiwan
|
114 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
115 Participants
n=483 Participants
|
|
Region of Enrollment
Thailand
|
33 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
33 Participants
n=483 Participants
|
|
Region of Enrollment
United Kingdom
|
41 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
42 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
9812 Participants
n=93 Participants
|
160 Participants
n=4 Participants
|
31 Participants
n=27 Participants
|
10003 Participants
n=483 Participants
|
|
Diagnostic Groups
Chronic Renal Insufficiency (CRI)
|
87 participants
n=93 Participants
|
0 participants
n=4 Participants
|
0 participants
n=27 Participants
|
87 participants
n=483 Participants
|
|
Diagnostic Groups
Growth Hormone Deficiency (GHD
|
14049 participants
n=93 Participants
|
102 participants
n=4 Participants
|
22 participants
n=27 Participants
|
14173 participants
n=483 Participants
|
|
Diagnostic Groups
Idiopathic Short Stature (ISS)
|
2844 participants
n=93 Participants
|
27 participants
n=4 Participants
|
5 participants
n=27 Participants
|
2876 participants
n=483 Participants
|
|
Diagnostic Groups
All Other Diagnostic Groups Not Listed
|
1226 participants
n=93 Participants
|
96 participants
n=4 Participants
|
5 participants
n=27 Participants
|
1327 participants
n=483 Participants
|
|
Diagnostic Groups
Born Small for Gestational Age (SGA)
|
1276 participants
n=93 Participants
|
18 participants
n=4 Participants
|
1 participants
n=27 Participants
|
1295 participants
n=483 Participants
|
|
Diagnostic Groups
SHOX Deficiency (SHOX-D)
|
576 participants
n=93 Participants
|
126 participants
n=4 Participants
|
3 participants
n=27 Participants
|
705 participants
n=483 Participants
|
|
Diagnostic Groups
Turner Syndrome (TS)
|
1870 participants
n=93 Participants
|
42 participants
n=4 Participants
|
1 participants
n=27 Participants
|
1913 participants
n=483 Participants
|
|
Diagnostic Groups
Unknown
|
383 participants
n=93 Participants
|
46 participants
n=4 Participants
|
40 participants
n=27 Participants
|
469 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Year 15Population: All treated participants with available age and calculable follow-up time. The treated participants were not compared with untreated but with rates from general population registries. The untreated participants predominantly contained neoplasm or SHOX deficient diagnoses, therefore had significant baseline differences from treated participants.
Outcome measures
| Measure |
Treated
n=21448 Participants
Participants treated with somatropin for improvement of growth
Somatropin (recombinant deoxyribonucleic acid \[rDNA\] origin): Dose, frequency and duration at discretion of attending physician.
|
Untreated
Participants not treated with a history of neoplasia or in those with any short stature homeobox (SHOX)-related disorder.
|
Unknown
Treatment with somatropin unknown.
|
|---|---|---|---|
|
Type 2 Diabetes Mellitus in GH-treated Participants
Ages 0 to 9
|
1 Incident Cases
|
—
|
—
|
|
Type 2 Diabetes Mellitus in GH-treated Participants
Ages 10 to 14
|
9 Incident Cases
|
—
|
—
|
|
Type 2 Diabetes Mellitus in GH-treated Participants
Ages 15 to 19
|
8 Incident Cases
|
—
|
—
|
PRIMARY outcome
Timeframe: Year 15Population: All treated participants with available age, gender, and at least one follow-up excluding participants with previous cancer cases. Due to the small number of participants involved, untreated and unknown treatment groups, data was not provided and could not be calculated.
Due to the small number of participants involved, untreated and unknown treatment groups, data was not provided and could not be calculated.
Outcome measures
| Measure |
Treated
n=20146 Participants
Participants treated with somatropin for improvement of growth
Somatropin (recombinant deoxyribonucleic acid \[rDNA\] origin): Dose, frequency and duration at discretion of attending physician.
|
Untreated
Participants not treated with a history of neoplasia or in those with any short stature homeobox (SHOX)-related disorder.
|
Unknown
Treatment with somatropin unknown.
|
|---|---|---|---|
|
Primary Malignancies in Participant Without Previous Cancer History
|
14 Incident Cases
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline through Year 15Population: All treated participants who reached final height (at least 1: closed epiphyses, height velocity \<2 centimeters per year, or last bone age \>14 years \[girls\] or \>16 years \[boys\]) with baseline height SDS and final height available. Data was not provided for untreated and unknown treatment groups, and could not be calculated.
The standard deviation score (SDS) reports the number of standard deviations from the mean for age and sex for an individual measurement (normal range is -2 to +2 SDS). Height SDS is derived by subtracting the population mean from individual's height value and then dividing that difference by the population standard deviation. Greater height SDS values indicate greater height. Due to the small number of participants involved, untreated and unknown treatment groups, data was not provided and could not be calculated.
Outcome measures
| Measure |
Treated
n=5075 Participants
Participants treated with somatropin for improvement of growth
Somatropin (recombinant deoxyribonucleic acid \[rDNA\] origin): Dose, frequency and duration at discretion of attending physician.
|
Untreated
Participants not treated with a history of neoplasia or in those with any short stature homeobox (SHOX)-related disorder.
|
Unknown
Treatment with somatropin unknown.
|
|---|---|---|---|
|
Final Height (FH) Gain by Diagnostic Group
All Baseline Height
|
-2.42 standard deviation score
Standard Deviation 1.01
|
—
|
—
|
|
Final Height (FH) Gain by Diagnostic Group
All Final Height
|
-1.18 standard deviation score
Standard Deviation 1.12
|
—
|
—
|
|
Final Height (FH) Gain by Diagnostic Group
All Final Height Gain
|
1.24 standard deviation score
Standard Deviation 1.08
|
—
|
—
|
|
Final Height (FH) Gain by Diagnostic Group
GHD Baseline Height
|
-2.35 standard deviation score
Standard Deviation 1.04
|
—
|
—
|
|
Final Height (FH) Gain by Diagnostic Group
GHD Final Height
|
-0.96 standard deviation score
Standard Deviation 1.12
|
—
|
—
|
|
Final Height (FH) Gain by Diagnostic Group
GHD Final Height Gain
|
1.39 standard deviation score
Standard Deviation 1.14
|
—
|
—
|
|
Final Height (FH) Gain by Diagnostic Group
TS Baseline Height
|
-2.65 standard deviation score
Standard Deviation .089
|
—
|
—
|
|
Final Height (FH) Gain by Diagnostic Group
TS Final Height
|
-1.70 standard deviation score
Standard Deviation 0.94
|
—
|
—
|
|
Final Height (FH) Gain by Diagnostic Group
TS Final Height Gain
|
0.95 standard deviation score
Standard Deviation 0.82
|
—
|
—
|
|
Final Height (FH) Gain by Diagnostic Group
ISS Baseline Height
|
-2.37 standard deviation score
Standard Deviation 0.80
|
—
|
—
|
|
Final Height (FH) Gain by Diagnostic Group
ISS Final Height
|
-1.26 standard deviation score
Standard Deviation 0.96
|
—
|
—
|
|
Final Height (FH) Gain by Diagnostic Group
ISS Final Height Gain
|
1.10 standard deviation score
Standard Deviation 0.98
|
—
|
—
|
|
Final Height (FH) Gain by Diagnostic Group
SHOX-D Baseline Height
|
-2.36 standard deviation score
Standard Deviation 0.79
|
—
|
—
|
|
Final Height (FH) Gain by Diagnostic Group
SHOX-D Final Height
|
-1.50 standard deviation score
Standard Deviation 0.97
|
—
|
—
|
|
Final Height (FH) Gain by Diagnostic Group
SHOX-D Final Height Gain
|
0.86 standard deviation score
Standard Deviation 0.91
|
—
|
—
|
|
Final Height (FH) Gain by Diagnostic Group
SGA Baseline Height
|
-2.57 standard deviation score
Standard Deviation 0.86
|
—
|
—
|
|
Final Height (FH) Gain by Diagnostic Group
SGA Final Height
|
-1.47 standard deviation score
Standard Deviation 0.84
|
—
|
—
|
|
Final Height (FH) Gain by Diagnostic Group
SGA Final Height Gain
|
1.11 standard deviation score
Standard Deviation 0.96
|
—
|
—
|
|
Final Height (FH) Gain by Diagnostic Group
CRI Baseline Height
|
-2.54 standard deviation score
Standard Deviation 0.90
|
—
|
—
|
|
Final Height (FH) Gain by Diagnostic Group
CRI Final Height
|
-1.66 standard deviation score
Standard Deviation 1.27
|
—
|
—
|
|
Final Height (FH) Gain by Diagnostic Group
CRI Final Height Gain
|
0.88 standard deviation score
Standard Deviation 0.81
|
—
|
—
|
|
Final Height (FH) Gain by Diagnostic Group
Other Baseline Height
|
-2.70 standard deviation score
Standard Deviation 1.32
|
—
|
—
|
|
Final Height (FH) Gain by Diagnostic Group
Other Final Height
|
-1.69 standard deviation score
Standard Deviation 1.33
|
—
|
—
|
|
Final Height (FH) Gain by Diagnostic Group
Other Final Height Gain
|
1.01 standard deviation score
Standard Deviation 1.10
|
—
|
—
|
|
Final Height (FH) Gain by Diagnostic Group
Unknown Baseline Height
|
-2.30 standard deviation score
Standard Deviation 1.02
|
—
|
—
|
|
Final Height (FH) Gain by Diagnostic Group
Unknown Final Height
|
-1.54 standard deviation score
Standard Deviation 1.10
|
—
|
—
|
|
Final Height (FH) Gain by Diagnostic Group
Unknown Final Height Gain
|
0.75 standard deviation score
Standard Deviation 0.83
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline through Year 15Population: All SME participants (including treated, untreated, and unknown groups) with available results of DNA (deoxyribonucleic acid) analysis available and GHD diagnosis.
Percentage of participants with genetic defects associated with pituitary development. Genes included but were not limited to GH1, Growth hormone releasing hormone receptor (GHRHR), Homeobox gene expressed in embryonic stem cells (HESX1), LIM homeobox 3 (LHX3), POU domain, class 1, transcription factor 1 (POU1F1), and Prophet of Pit1 (PROP1).
Outcome measures
| Measure |
Treated
n=476 Participants
Participants treated with somatropin for improvement of growth
Somatropin (recombinant deoxyribonucleic acid \[rDNA\] origin): Dose, frequency and duration at discretion of attending physician.
|
Untreated
n=412 Participants
Participants not treated with a history of neoplasia or in those with any short stature homeobox (SHOX)-related disorder.
|
Unknown
n=26 Participants
Treatment with somatropin unknown.
|
|---|---|---|---|
|
Percentage of Participants With Defects in Genes Associated With Pituitary Development
|
6.7 percentage of participants
|
14.8 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline through Year 15Population: All participants with predicted and actual first year height gain available and TS or GHD diagnosis. Data was not provided for untreated and unknown treatment groups, and could not be calculated.
The value for predicted and observed is of limited bearing, it is how each participant's predicted versus observed height gain compare and this is best estimated by the R-squared. An estimation parameter would not be a correct format for the R2 data. R2 can take value between 0 and 1 with values closer to 0 representing a poor fit while values closer to 1 representing a perfect fit
Outcome measures
| Measure |
Treated
n=999 Participants
Participants treated with somatropin for improvement of growth
Somatropin (recombinant deoxyribonucleic acid \[rDNA\] origin): Dose, frequency and duration at discretion of attending physician.
|
Untreated
Participants not treated with a history of neoplasia or in those with any short stature homeobox (SHOX)-related disorder.
|
Unknown
Treatment with somatropin unknown.
|
|---|---|---|---|
|
Predicted First Year Height Gain Versus Actual First Year Height Gain
TS
|
0.261 R Squared
|
—
|
—
|
|
Predicted First Year Height Gain Versus Actual First Year Height Gain
GHD
|
0.408 R Squared
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Year 15Population: All SHOX-D Participants, GH-treated, with available height SDS at baseline and final height. Data was not provided for untreated and unknown treatment groups, and could not be calculated.
Outcome measures
| Measure |
Treated
n=144 Participants
Participants treated with somatropin for improvement of growth
Somatropin (recombinant deoxyribonucleic acid \[rDNA\] origin): Dose, frequency and duration at discretion of attending physician.
|
Untreated
Participants not treated with a history of neoplasia or in those with any short stature homeobox (SHOX)-related disorder.
|
Unknown
Treatment with somatropin unknown.
|
|---|---|---|---|
|
Change From Baseline to Final Height in Anthropometric Measures for Participants With SHOX Deficiency
Height SDS
|
0.8 standard deviation score
Standard Deviation 0.9
|
—
|
—
|
|
Change From Baseline to Final Height in Anthropometric Measures for Participants With SHOX Deficiency
Sitting Height (SH) SDS
|
1.4 standard deviation score
Standard Deviation 1.0
|
—
|
—
|
|
Change From Baseline to Final Height in Anthropometric Measures for Participants With SHOX Deficiency
Arm Span (AS) SDS
|
-0.6 standard deviation score
Standard Deviation 6.2
|
—
|
—
|
|
Change From Baseline to Final Height in Anthropometric Measures for Participants With SHOX Deficiency
SH SDS/Height SDS
|
-0.7 standard deviation score
Standard Deviation 1.8
|
—
|
—
|
|
Change From Baseline to Final Height in Anthropometric Measures for Participants With SHOX Deficiency
AS SDS/Height SDS
|
1.0 standard deviation score
Standard Deviation 3.0
|
—
|
—
|
|
Change From Baseline to Final Height in Anthropometric Measures for Participants With SHOX Deficiency
AS SDS/SH SDS
|
10.2 standard deviation score
Standard Deviation 22.9
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline through Year 15Population: All SME, treated participants with previous neoplastic disease and at least one follow-up visit. Data was not provided for untreated and unknown treatment groups, and could not be calculated.
Percentage of participants with recurrence/progression of primary neoplastic disease and/or development of secondary neoplasms in childhood cancer survivors.
Outcome measures
| Measure |
Treated
n=1087 Participants
Participants treated with somatropin for improvement of growth
Somatropin (recombinant deoxyribonucleic acid \[rDNA\] origin): Dose, frequency and duration at discretion of attending physician.
|
Untreated
Participants not treated with a history of neoplasia or in those with any short stature homeobox (SHOX)-related disorder.
|
Unknown
Treatment with somatropin unknown.
|
|---|---|---|---|
|
Percentage of Participants With Recurrent Neoplasms and Second Neoplasms in Childhood Cancer Survivors
Recurrences
|
6.81 percentage of participants
|
—
|
—
|
|
Percentage of Participants With Recurrent Neoplasms and Second Neoplasms in Childhood Cancer Survivors
Second Neoplasms
|
4.98 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline through Year 15Population: All SME, GH-treated participants with at least one follow-up visit. Data was not provided for untreated and unknown treatment groups, and could not be calculated.
Percentage of participants with the development of de novo neoplastic disease with no history of prior neoplasia.
Outcome measures
| Measure |
Treated
n=20556 Participants
Participants treated with somatropin for improvement of growth
Somatropin (recombinant deoxyribonucleic acid \[rDNA\] origin): Dose, frequency and duration at discretion of attending physician.
|
Untreated
Participants not treated with a history of neoplasia or in those with any short stature homeobox (SHOX)-related disorder.
|
Unknown
Treatment with somatropin unknown.
|
|---|---|---|---|
|
Percentage of Participants With De Novo Neoplasms
|
0.07 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline through Year 15Population: All treated participants with available age and calculable follow-up time, and diabetes mellitus (DM), type 1 diabetes mellitus (T1) or type 2 diabetes mellitus (T2). Data was not provided for untreated and unknown treatment groups, and could not be calculated.
Outcome measures
| Measure |
Treated
n=21448 Participants
Participants treated with somatropin for improvement of growth
Somatropin (recombinant deoxyribonucleic acid \[rDNA\] origin): Dose, frequency and duration at discretion of attending physician.
|
Untreated
Participants not treated with a history of neoplasia or in those with any short stature homeobox (SHOX)-related disorder.
|
Unknown
Treatment with somatropin unknown.
|
|---|---|---|---|
|
Diabetes Mellitus (DM) in Somatropin-Treated Children With Different Short Stature Diagnoses
All DM
|
38 Incident Cases
|
—
|
—
|
|
Diabetes Mellitus (DM) in Somatropin-Treated Children With Different Short Stature Diagnoses
GHD DM
|
22 Incident Cases
|
—
|
—
|
|
Diabetes Mellitus (DM) in Somatropin-Treated Children With Different Short Stature Diagnoses
TS DM
|
6 Incident Cases
|
—
|
—
|
|
Diabetes Mellitus (DM) in Somatropin-Treated Children With Different Short Stature Diagnoses
ISS DM
|
4 Incident Cases
|
—
|
—
|
|
Diabetes Mellitus (DM) in Somatropin-Treated Children With Different Short Stature Diagnoses
SHOX-D DM
|
0 Incident Cases
|
—
|
—
|
|
Diabetes Mellitus (DM) in Somatropin-Treated Children With Different Short Stature Diagnoses
SGA DM
|
2 Incident Cases
|
—
|
—
|
|
Diabetes Mellitus (DM) in Somatropin-Treated Children With Different Short Stature Diagnoses
Other DM
|
4 Incident Cases
|
—
|
—
|
|
Diabetes Mellitus (DM) in Somatropin-Treated Children With Different Short Stature Diagnoses
Unknown DM
|
0 Incident Cases
|
—
|
—
|
|
Diabetes Mellitus (DM) in Somatropin-Treated Children With Different Short Stature Diagnoses
All T1
|
19 Incident Cases
|
—
|
—
|
|
Diabetes Mellitus (DM) in Somatropin-Treated Children With Different Short Stature Diagnoses
GHD T1
|
10 Incident Cases
|
—
|
—
|
|
Diabetes Mellitus (DM) in Somatropin-Treated Children With Different Short Stature Diagnoses
TS T1
|
3 Incident Cases
|
—
|
—
|
|
Diabetes Mellitus (DM) in Somatropin-Treated Children With Different Short Stature Diagnoses
ISS T1
|
3 Incident Cases
|
—
|
—
|
|
Diabetes Mellitus (DM) in Somatropin-Treated Children With Different Short Stature Diagnoses
SHOX-D T1
|
0 Incident Cases
|
—
|
—
|
|
Diabetes Mellitus (DM) in Somatropin-Treated Children With Different Short Stature Diagnoses
SGA T1
|
0 Incident Cases
|
—
|
—
|
|
Diabetes Mellitus (DM) in Somatropin-Treated Children With Different Short Stature Diagnoses
SHOX-D T2
|
0 Incident Cases
|
—
|
—
|
|
Diabetes Mellitus (DM) in Somatropin-Treated Children With Different Short Stature Diagnoses
SGA T2
|
2 Incident Cases
|
—
|
—
|
|
Diabetes Mellitus (DM) in Somatropin-Treated Children With Different Short Stature Diagnoses
Other T2
|
1 Incident Cases
|
—
|
—
|
|
Diabetes Mellitus (DM) in Somatropin-Treated Children With Different Short Stature Diagnoses
Unknown T2
|
0 Incident Cases
|
—
|
—
|
|
Diabetes Mellitus (DM) in Somatropin-Treated Children With Different Short Stature Diagnoses
Other T1
|
3 Incident Cases
|
—
|
—
|
|
Diabetes Mellitus (DM) in Somatropin-Treated Children With Different Short Stature Diagnoses
Unknown T1
|
0 Incident Cases
|
—
|
—
|
|
Diabetes Mellitus (DM) in Somatropin-Treated Children With Different Short Stature Diagnoses
All T2
|
18 Incident Cases
|
—
|
—
|
|
Diabetes Mellitus (DM) in Somatropin-Treated Children With Different Short Stature Diagnoses
GHD T2
|
12 Incident Cases
|
—
|
—
|
|
Diabetes Mellitus (DM) in Somatropin-Treated Children With Different Short Stature Diagnoses
TS T2
|
3 Incident Cases
|
—
|
—
|
|
Diabetes Mellitus (DM) in Somatropin-Treated Children With Different Short Stature Diagnoses
ISS T2
|
0 Incident Cases
|
—
|
—
|
Adverse Events
Treated
Serious events: 547 serious events
Other events: 6180 other events
Deaths: 0 deaths
Untreated
Serious events: 14 serious events
Other events: 126 other events
Deaths: 0 deaths
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treated
n=21177 participants at risk
Treatment with Humatrope for improvement of growth.
|
Untreated
n=306 participants at risk
No treatment with somatropin in participants with a history of neoplasia or in those with any SHOX deficiency-related disorder.
|
n=40 participants at risk
Treatment with Humatrope unknown.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.02%
4/21177 • Number of events 4
|
0.00%
0/306
|
0.00%
0/40
|
|
Blood and lymphatic system disorders
Aplastic anaemia
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
1/21177 • Number of events 1
|
0.33%
1/306 • Number of events 2
|
0.00%
0/40
|
|
Blood and lymphatic system disorders
Immune thrombocytopenic purpura
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
1/21177 • Number of events 1
|
0.33%
1/306 • Number of events 1
|
0.00%
0/40
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Blood and lymphatic system disorders
Thrombotic microangiopathy
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Cardiac disorders
Aortic valve incompetence
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Cardiac disorders
Aortic valve stenosis
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Cardiac disorders
Arrhythmia
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Cardiac disorders
Bradycardia
|
0.01%
2/21177 • Number of events 2
|
0.00%
0/306
|
0.00%
0/40
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Cardiac disorders
Cardiac disorder
|
0.01%
2/21177 • Number of events 2
|
0.00%
0/306
|
0.00%
0/40
|
|
Cardiac disorders
Cardiac failure congestive
|
0.01%
2/21177 • Number of events 2
|
0.00%
0/306
|
0.00%
0/40
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.01%
2/21177 • Number of events 2
|
0.00%
0/306
|
0.00%
0/40
|
|
Cardiac disorders
Cardiovascular disorder
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Cardiac disorders
Pulmonary valve disease
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Cardiac disorders
Tachycardia
|
0.01%
2/21177 • Number of events 2
|
0.00%
0/306
|
0.00%
0/40
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Congenital, familial and genetic disorders
Arnold-chiari malformation
|
0.01%
2/21177 • Number of events 2
|
0.00%
0/306
|
0.00%
0/40
|
|
Congenital, familial and genetic disorders
Brachydactyly
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Congenital, familial and genetic disorders
Coarctation of the aorta
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Congenital, familial and genetic disorders
Congenital aplastic anaemia
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Congenital, familial and genetic disorders
Cryptorchism
|
0.02%
2/12692 • Number of events 2
|
0.00%
0/306
|
0.00%
0/40
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.01%
1/12692 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Congenital, familial and genetic disorders
Imperforate hymen
|
0.01%
1/8458 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Congenital, familial and genetic disorders
Intestinal malrotation
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Congenital, familial and genetic disorders
Laryngomalacia
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Congenital, familial and genetic disorders
Oculoauriculovertebral dysplasia
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Congenital, familial and genetic disorders
Prader-willi syndrome
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Congenital, familial and genetic disorders
Rathke's cleft cyst
|
0.00%
1/21177 • Number of events 2
|
0.00%
0/306
|
0.00%
0/40
|
|
Congenital, familial and genetic disorders
Tourette's disorder
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Congenital, familial and genetic disorders
Ventricular septal defect
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Ear and labyrinth disorders
Deafness
|
0.01%
2/21177 • Number of events 2
|
0.00%
0/306
|
0.00%
0/40
|
|
Ear and labyrinth disorders
Deafness unilateral
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Ear and labyrinth disorders
Middle ear disorder
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Ear and labyrinth disorders
Tympanic membrane disorder
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Ear and labyrinth disorders
Tympanic membrane perforation
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Endocrine disorders
Adrenal insufficiency
|
0.02%
5/21177 • Number of events 6
|
0.00%
0/306
|
0.00%
0/40
|
|
Endocrine disorders
Adrenocortical insufficiency acute
|
0.05%
10/21177 • Number of events 13
|
0.00%
0/306
|
0.00%
0/40
|
|
Endocrine disorders
Diabetes insipidus
|
0.02%
4/21177 • Number of events 4
|
0.00%
0/306
|
0.00%
0/40
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Endocrine disorders
Precocious puberty
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Endocrine disorders
Secondary adrenocortical insufficiency
|
0.01%
3/21177 • Number of events 3
|
0.00%
0/306
|
0.00%
0/40
|
|
Endocrine disorders
Secondary hypogonadism
|
0.01%
2/21177 • Number of events 2
|
0.00%
0/306
|
0.00%
0/40
|
|
Eye disorders
Cataract
|
0.01%
2/21177 • Number of events 2
|
0.00%
0/306
|
0.00%
0/40
|
|
Eye disorders
Deformity of orbit
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Eye disorders
Iridocyclitis
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Eye disorders
Keratoconus
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Eye disorders
Oculogyric crisis
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Eye disorders
Papilloedema
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Eye disorders
Retinal detachment
|
0.01%
3/21177 • Number of events 3
|
0.00%
0/306
|
0.00%
0/40
|
|
Eye disorders
Strabismus
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Eye disorders
Uveitis
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Eye disorders
Visual acuity reduced
|
0.01%
2/21177 • Number of events 2
|
0.00%
0/306
|
0.00%
0/40
|
|
Gastrointestinal disorders
Abdominal pain
|
0.02%
4/21177 • Number of events 5
|
0.00%
0/306
|
0.00%
0/40
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Gastrointestinal disorders
Constipation
|
0.01%
2/21177 • Number of events 2
|
0.00%
0/306
|
0.00%
0/40
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/21177
|
0.33%
1/306 • Number of events 1
|
0.00%
0/40
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.01%
2/21177 • Number of events 2
|
0.00%
0/306
|
0.00%
0/40
|
|
Gastrointestinal disorders
Ileus
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.02%
5/21177 • Number of events 5
|
0.00%
0/306
|
0.00%
0/40
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.01%
2/21177 • Number of events 2
|
0.00%
0/306
|
0.00%
0/40
|
|
Gastrointestinal disorders
Intra-abdominal haemorrhage
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Gastrointestinal disorders
Large intestinal haemorrhage
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Gastrointestinal disorders
Melaena
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Gastrointestinal disorders
Nausea
|
0.02%
4/21177 • Number of events 4
|
0.00%
0/306
|
0.00%
0/40
|
|
Gastrointestinal disorders
Oesophageal rupture
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Gastrointestinal disorders
Pneumatosis intestinalis
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Gastrointestinal disorders
Rectal fissure
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Gastrointestinal disorders
Rectal polyp
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Gastrointestinal disorders
Volvulus
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Gastrointestinal disorders
Vomiting
|
0.08%
16/21177 • Number of events 22
|
0.00%
0/306
|
0.00%
0/40
|
|
General disorders
Asthenia
|
0.01%
2/21177 • Number of events 2
|
0.00%
0/306
|
0.00%
0/40
|
|
General disorders
Chest pain
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
General disorders
Cyst
|
0.01%
2/21177 • Number of events 2
|
0.00%
0/306
|
0.00%
0/40
|
|
General disorders
Death
|
0.02%
4/21177 • Number of events 4
|
0.00%
0/306
|
0.00%
0/40
|
|
General disorders
Device malfunction
|
0.01%
2/21177 • Number of events 3
|
0.33%
1/306 • Number of events 1
|
0.00%
0/40
|
|
General disorders
Hypothermia
|
0.01%
2/21177 • Number of events 2
|
0.00%
0/306
|
0.00%
0/40
|
|
General disorders
Impaired healing
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
General disorders
Malaise
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
General disorders
Oedema
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
General disorders
Oedema peripheral
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
General disorders
Pyrexia
|
0.03%
6/21177 • Number of events 8
|
0.00%
0/306
|
0.00%
0/40
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.01%
2/21177 • Number of events 2
|
0.00%
0/306
|
0.00%
0/40
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Immune system disorders
Anaphylactic reaction
|
0.01%
2/21177 • Number of events 2
|
0.00%
0/306
|
0.00%
0/40
|
|
Immune system disorders
Anaphylactoid reaction
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Immune system disorders
Kidney transplant rejection
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Infections and infestations
Appendicitis
|
0.07%
14/21177 • Number of events 14
|
0.00%
0/306
|
0.00%
0/40
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Infections and infestations
Bacteraemia
|
0.00%
1/21177 • Number of events 1
|
0.33%
1/306 • Number of events 1
|
0.00%
0/40
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Infections and infestations
Brain abscess
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Infections and infestations
Bronchitis
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Infections and infestations
Catheter site cellulitis
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Infections and infestations
Cellulitis
|
0.01%
2/21177 • Number of events 2
|
0.00%
0/306
|
0.00%
0/40
|
|
Infections and infestations
Cellulitis orbital
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Infections and infestations
Cholangitis infective
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Infections and infestations
Cytomegalovirus infection
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Infections and infestations
Device related infection
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Infections and infestations
Ear infection
|
0.01%
2/21177 • Number of events 2
|
0.00%
0/306
|
0.00%
0/40
|
|
Infections and infestations
Encephalitis
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Infections and infestations
Gastroenteritis
|
0.08%
17/21177 • Number of events 18
|
0.00%
0/306
|
0.00%
0/40
|
|
Infections and infestations
Gastroenteritis rotavirus
|
0.01%
2/21177 • Number of events 2
|
0.00%
0/306
|
0.00%
0/40
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Infections and infestations
Gastroenteritis viral
|
0.02%
4/21177 • Number of events 4
|
0.00%
0/306
|
0.00%
0/40
|
|
Infections and infestations
H1n1 influenza
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Infections and infestations
Haemophilus infection
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Infections and infestations
Hepatitis a
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Infections and infestations
Hepatitis viral
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Infections and infestations
Herpes simplex
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Infections and infestations
Herpes zoster disseminated
|
0.00%
0/21177
|
0.33%
1/306 • Number of events 1
|
0.00%
0/40
|
|
Infections and infestations
Infectious mononucleosis
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Infections and infestations
Infective pulmonary exacerbation of cystic fibrosis
|
0.01%
2/21177 • Number of events 3
|
0.00%
0/306
|
0.00%
0/40
|
|
Infections and infestations
Influenza
|
0.03%
7/21177 • Number of events 7
|
0.00%
0/306
|
0.00%
0/40
|
|
Infections and infestations
Latent tuberculosis
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Infections and infestations
Lymph node tuberculosis
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Infections and infestations
Mastoiditis
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Infections and infestations
Meningitis
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Infections and infestations
Meningitis aseptic
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Infections and infestations
Meningitis bacterial
|
0.01%
2/21177 • Number of events 2
|
0.00%
0/306
|
0.00%
0/40
|
|
Infections and infestations
Meningitis viral
|
0.01%
2/21177 • Number of events 2
|
0.00%
0/306
|
0.00%
0/40
|
|
Infections and infestations
Mycoplasma infection
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Infections and infestations
Osteomyelitis
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Infections and infestations
Otitis media
|
0.01%
2/21177 • Number of events 2
|
0.00%
0/306
|
0.00%
0/40
|
|
Infections and infestations
Otitis media chronic
|
0.01%
2/21177 • Number of events 2
|
0.00%
0/306
|
0.00%
0/40
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Infections and infestations
Parotitis
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Infections and infestations
Peritonsillar abscess
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Infections and infestations
Pharyngitis
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Infections and infestations
Pneumococcal bacteraemia
|
0.00%
0/21177
|
0.33%
1/306 • Number of events 1
|
0.00%
0/40
|
|
Infections and infestations
Pneumonia
|
0.10%
22/21177 • Number of events 28
|
0.33%
1/306 • Number of events 1
|
0.00%
0/40
|
|
Infections and infestations
Pneumonia mycoplasmal
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Infections and infestations
Pneumonia pseudomonal
|
0.00%
1/21177 • Number of events 2
|
0.00%
0/306
|
0.00%
0/40
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Infections and infestations
Post procedural infection
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Infections and infestations
Pyelonephritis
|
0.03%
7/21177 • Number of events 7
|
0.00%
0/306
|
0.00%
0/40
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Infections and infestations
Respiratory tract infection
|
0.01%
2/21177 • Number of events 11
|
0.00%
0/306
|
0.00%
0/40
|
|
Infections and infestations
Respiratory tract infection viral
|
0.01%
2/21177 • Number of events 2
|
0.00%
0/306
|
0.00%
0/40
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/21177
|
0.33%
1/306 • Number of events 1
|
0.00%
0/40
|
|
Infections and infestations
Rotavirus infection
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Infections and infestations
Sepsis
|
0.02%
5/21177 • Number of events 5
|
0.00%
0/306
|
0.00%
0/40
|
|
Infections and infestations
Septic shock
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Infections and infestations
Shunt infection
|
0.01%
2/21177 • Number of events 2
|
0.00%
0/306
|
0.00%
0/40
|
|
Infections and infestations
Sinusitis
|
0.02%
5/21177 • Number of events 5
|
0.33%
1/306 • Number of events 1
|
0.00%
0/40
|
|
Infections and infestations
Tonsillitis
|
0.01%
2/21177 • Number of events 2
|
0.00%
0/306
|
0.00%
0/40
|
|
Infections and infestations
Upper respiratory tract infection
|
0.01%
2/21177 • Number of events 2
|
0.00%
0/306
|
0.00%
0/40
|
|
Infections and infestations
Urinary tract infection
|
0.03%
7/21177 • Number of events 7
|
0.00%
0/306
|
0.00%
0/40
|
|
Infections and infestations
Urosepsis
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Infections and infestations
Varicella
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Infections and infestations
Viral infection
|
0.04%
9/21177 • Number of events 11
|
0.33%
1/306 • Number of events 1
|
0.00%
0/40
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Infections and infestations
Wound infection
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Injury, poisoning and procedural complications
Accident
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.01%
2/21177 • Number of events 2
|
0.00%
0/306
|
0.00%
0/40
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/21177
|
0.33%
1/306 • Number of events 1
|
0.00%
0/40
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.01%
2/21177 • Number of events 2
|
0.00%
0/306
|
0.00%
0/40
|
|
Injury, poisoning and procedural complications
Face injury
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.01%
2/21177 • Number of events 2
|
0.00%
0/306
|
0.00%
0/40
|
|
Injury, poisoning and procedural complications
Fall
|
0.03%
6/21177 • Number of events 6
|
0.00%
0/306
|
0.00%
0/40
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.02%
4/21177 • Number of events 4
|
0.00%
0/306
|
0.00%
0/40
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.00%
1/21177 • Number of events 1
|
0.33%
1/306 • Number of events 1
|
0.00%
0/40
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.01%
3/21177 • Number of events 3
|
0.00%
0/306
|
0.00%
0/40
|
|
Injury, poisoning and procedural complications
Head injury
|
0.02%
4/21177 • Number of events 4
|
0.00%
0/306
|
0.00%
0/40
|
|
Injury, poisoning and procedural complications
Hepatic rupture
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Injury, poisoning and procedural complications
Injury
|
0.01%
3/21177 • Number of events 3
|
0.00%
0/306
|
0.00%
0/40
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.01%
2/21177 • Number of events 2
|
0.00%
0/306
|
0.00%
0/40
|
|
Injury, poisoning and procedural complications
Ligament injury
|
0.00%
1/21177 • Number of events 2
|
0.00%
0/306
|
0.00%
0/40
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Injury, poisoning and procedural complications
Limb traumatic amputation
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.03%
6/21177 • Number of events 6
|
0.00%
0/306
|
0.00%
0/40
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Injury, poisoning and procedural complications
Radiation injury
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.01%
3/21177 • Number of events 3
|
0.00%
0/306
|
0.00%
0/40
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.03%
6/21177 • Number of events 6
|
0.00%
0/306
|
0.00%
0/40
|
|
Injury, poisoning and procedural complications
Shunt malfunction
|
0.01%
2/21177 • Number of events 2
|
0.00%
0/306
|
0.00%
0/40
|
|
Injury, poisoning and procedural complications
Shunt occlusion
|
0.01%
2/21177 • Number of events 2
|
0.00%
0/306
|
0.00%
0/40
|
|
Injury, poisoning and procedural complications
Splenic injury
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Injury, poisoning and procedural complications
Splenic rupture
|
0.01%
2/21177 • Number of events 2
|
0.00%
0/306
|
0.00%
0/40
|
|
Injury, poisoning and procedural complications
Sports injury
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.01%
2/21177 • Number of events 2
|
0.00%
0/306
|
0.00%
0/40
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Injury, poisoning and procedural complications
Traumatic renal injury
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.01%
2/21177 • Number of events 2
|
0.00%
0/306
|
0.00%
0/40
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.01%
3/21177 • Number of events 3
|
0.00%
0/306
|
0.00%
0/40
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Investigations
Blood creatine phosphokinase increased
|
0.01%
2/21177 • Number of events 2
|
0.00%
0/306
|
0.00%
0/40
|
|
Investigations
Body temperature fluctuation
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Investigations
Hepatic enzyme increased
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Investigations
Insulin-like growth factor increased
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Investigations
Salmonella test positive
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Investigations
Staphylococcus test positive
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Investigations
Transaminases increased
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Metabolism and nutrition disorders
Dehydration
|
0.04%
8/21177 • Number of events 10
|
0.00%
0/306
|
0.00%
0/40
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.01%
2/21177 • Number of events 2
|
0.00%
0/306
|
0.00%
0/40
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.01%
2/21177 • Number of events 2
|
0.00%
0/306
|
0.00%
0/40
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.01%
2/21177 • Number of events 2
|
0.00%
0/306
|
0.00%
0/40
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.08%
18/21177 • Number of events 23
|
0.00%
0/306
|
0.00%
0/40
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.01%
2/21177 • Number of events 2
|
0.00%
0/306
|
0.00%
0/40
|
|
Metabolism and nutrition disorders
Polydipsia
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Metabolism and nutrition disorders
Tetany
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.03%
6/21177 • Number of events 6
|
0.00%
0/306
|
0.00%
0/40
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Metabolism and nutrition disorders
Weight gain poor
|
0.00%
1/21177 • Number of events 2
|
0.00%
0/306
|
0.00%
0/40
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Musculoskeletal and connective tissue disorders
Bone cyst
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Musculoskeletal and connective tissue disorders
Bone development abnormal
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Musculoskeletal and connective tissue disorders
Bone disorder
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Musculoskeletal and connective tissue disorders
Bone lesion
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Musculoskeletal and connective tissue disorders
Compartment syndrome
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Musculoskeletal and connective tissue disorders
Epiphysiolysis
|
0.05%
11/21177 • Number of events 12
|
0.00%
0/306
|
0.00%
0/40
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Musculoskeletal and connective tissue disorders
Extremity contracture
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Musculoskeletal and connective tissue disorders
Juvenile idiopathic arthritis
|
0.01%
3/21177 • Number of events 3
|
0.00%
0/306
|
0.00%
0/40
|
|
Musculoskeletal and connective tissue disorders
Kyphoscoliosis
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Musculoskeletal and connective tissue disorders
Kyphosis
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Musculoskeletal and connective tissue disorders
Limb asymmetry
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Musculoskeletal and connective tissue disorders
Limb deformity
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.01%
2/21177 • Number of events 2
|
0.00%
0/306
|
0.00%
0/40
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Musculoskeletal and connective tissue disorders
Posture abnormal
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
0.05%
10/21177 • Number of events 10
|
0.00%
0/306
|
0.00%
0/40
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.01%
2/21177 • Number of events 2
|
0.00%
0/306
|
0.00%
0/40
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acoustic neuroma
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute lymphocytic leukaemia
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal neoplasm
|
0.00%
1/21177 • Number of events 2
|
0.00%
0/306
|
0.00%
0/40
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anaplastic astrocytoma
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Astrocytoma
|
0.01%
3/21177 • Number of events 3
|
0.33%
1/306 • Number of events 1
|
0.00%
0/40
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.02%
4/21177 • Number of events 4
|
0.33%
1/306 • Number of events 1
|
0.00%
0/40
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Burkitt's lymphoma
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Choroid neoplasm
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Craniopharyngioma
|
0.09%
19/21177 • Number of events 22
|
0.00%
0/306
|
0.00%
0/40
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ependymoma
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ewing's sarcoma
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroma
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibrous cortical defect
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioma
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Inflammatory pseudotumour
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Medulloblastoma
|
0.00%
1/21177 • Number of events 3
|
0.00%
0/306
|
0.00%
0/40
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Medulloblastoma recurrent
|
0.02%
4/21177 • Number of events 4
|
0.33%
1/306 • Number of events 1
|
0.00%
0/40
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.01%
3/21177 • Number of events 3
|
0.00%
0/306
|
0.00%
0/40
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
0.01%
2/21177 • Number of events 2
|
0.00%
0/306
|
0.00%
0/40
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm recurrence
|
0.01%
3/21177 • Number of events 3
|
0.00%
0/306
|
0.00%
0/40
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroblastoma recurrent
|
0.01%
2/21177 • Number of events 2
|
0.00%
0/306
|
0.00%
0/40
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neurofibroma
|
0.01%
2/21177 • Number of events 2
|
0.00%
0/306
|
0.00%
0/40
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Optic glioma
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Osteochondroma
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Osteoma
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Osteosarcoma
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian fibroma
|
0.01%
1/8458 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian germ cell teratoma benign
|
0.01%
1/8458 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic neuroendocrine tumour
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.01%
2/21177 • Number of events 2
|
0.00%
0/306
|
0.00%
0/40
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Peripheral nerve sheath tumour malignant
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Phaeochromocytoma
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour recurrent
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Primitive neuroectodermal tumour
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prolactinoma
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenocarcinoma
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sarcoma
|
0.00%
1/21177 • Number of events 1
|
0.33%
1/306 • Number of events 1
|
0.00%
0/40
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Spinal cord neoplasm
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Testicular germ cell cancer
|
0.01%
1/12692 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm malignant stage unspecified
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Nervous system disorders
Acquired epileptic aphasia
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Nervous system disorders
Benign intracranial hypertension
|
0.01%
3/21177 • Number of events 3
|
0.00%
0/306
|
0.00%
0/40
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.01%
2/21177 • Number of events 2
|
0.00%
0/306
|
0.00%
0/40
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Nervous system disorders
Conus medullaris syndrome
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Nervous system disorders
Dizziness
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Nervous system disorders
Dyslalia
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Nervous system disorders
Encephalopathy
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Nervous system disorders
Epilepsy
|
0.02%
4/21177 • Number of events 4
|
0.00%
0/306
|
0.00%
0/40
|
|
Nervous system disorders
Facial paresis
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Nervous system disorders
Febrile convulsion
|
0.01%
3/21177 • Number of events 3
|
0.00%
0/306
|
0.00%
0/40
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.01%
2/21177 • Number of events 2
|
0.00%
0/306
|
0.00%
0/40
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Nervous system disorders
Headache
|
0.04%
8/21177 • Number of events 8
|
0.33%
1/306 • Number of events 2
|
0.00%
0/40
|
|
Nervous system disorders
Hemiparesis
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Nervous system disorders
Hemiplegic migraine
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/21177
|
0.33%
1/306 • Number of events 1
|
0.00%
0/40
|
|
Nervous system disorders
Hypoglycaemic seizure
|
0.02%
4/21177 • Number of events 4
|
0.00%
0/306
|
0.00%
0/40
|
|
Nervous system disorders
Hypoxic-ischaemic encephalopathy
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Nervous system disorders
Infantile spasms
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Nervous system disorders
Intracranial pressure increased
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Nervous system disorders
Intraventricular haemorrhage
|
0.00%
0/21177
|
0.33%
1/306 • Number of events 1
|
0.00%
0/40
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Nervous system disorders
Lethargy
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Nervous system disorders
Loss of consciousness
|
0.01%
3/21177 • Number of events 3
|
0.00%
0/306
|
0.00%
0/40
|
|
Nervous system disorders
Meningism
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Nervous system disorders
Migraine
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Nervous system disorders
Migraine with aura
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Nervous system disorders
Moyamoya disease
|
0.01%
2/21177 • Number of events 3
|
0.00%
0/306
|
0.00%
0/40
|
|
Nervous system disorders
Myoclonus
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Nervous system disorders
Paraesthesia
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Nervous system disorders
Paraplegia
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Nervous system disorders
Partial seizures
|
0.01%
3/21177 • Number of events 3
|
0.00%
0/306
|
0.00%
0/40
|
|
Nervous system disorders
Peroneal nerve palsy
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Nervous system disorders
Petit mal epilepsy
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Nervous system disorders
Seizure
|
0.08%
16/21177 • Number of events 17
|
0.65%
2/306 • Number of events 2
|
0.00%
0/40
|
|
Nervous system disorders
Status epilepticus
|
0.01%
2/21177 • Number of events 2
|
0.33%
1/306 • Number of events 1
|
0.00%
0/40
|
|
Nervous system disorders
Tension headache
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Nervous system disorders
Tethered cord syndrome
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Nervous system disorders
Unresponsive to stimuli
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Nervous system disorders
Visual field defect
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Psychiatric disorders
Aggression
|
0.01%
2/21177 • Number of events 2
|
0.00%
0/306
|
0.00%
0/40
|
|
Psychiatric disorders
Anger
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Psychiatric disorders
Anorexia nervosa
|
0.01%
3/21177 • Number of events 3
|
0.00%
0/306
|
0.00%
0/40
|
|
Psychiatric disorders
Anxiety
|
0.01%
3/21177 • Number of events 3
|
0.00%
0/306
|
0.00%
0/40
|
|
Psychiatric disorders
Asperger's disorder
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/21177
|
0.33%
1/306 • Number of events 1
|
0.00%
0/40
|
|
Psychiatric disorders
Conversion disorder
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Psychiatric disorders
Depression
|
0.01%
2/21177 • Number of events 2
|
0.00%
0/306
|
0.00%
0/40
|
|
Psychiatric disorders
Eating disorder
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Psychiatric disorders
Mental disorder
|
0.01%
2/21177 • Number of events 2
|
0.00%
0/306
|
0.00%
0/40
|
|
Psychiatric disorders
Obsessive-compulsive disorder
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Psychiatric disorders
Phobia
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Psychiatric disorders
Reactive attachment disorder of infancy or early childhood
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Psychiatric disorders
Suicidal behaviour
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Psychiatric disorders
Suicidal ideation
|
0.01%
3/21177 • Number of events 3
|
0.00%
0/306
|
0.00%
0/40
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Renal and urinary disorders
Anuria
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.02%
5/21177 • Number of events 5
|
0.00%
0/306
|
0.00%
0/40
|
|
Renal and urinary disorders
Glomerulonephritis
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Renal and urinary disorders
Haematuria
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Renal and urinary disorders
Hypertonic bladder
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Renal and urinary disorders
Polyuria
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Renal and urinary disorders
Post streptococcal glomerulonephritis
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Renal and urinary disorders
Renal failure
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Renal and urinary disorders
Renal impairment
|
0.01%
2/21177 • Number of events 2
|
0.00%
0/306
|
0.00%
0/40
|
|
Renal and urinary disorders
Ureteric stenosis
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Reproductive system and breast disorders
Fallopian tube cyst
|
0.01%
1/8458 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.01%
1/8458 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.02%
2/8458 • Number of events 2
|
0.00%
0/306
|
0.00%
0/40
|
|
Reproductive system and breast disorders
Testicular torsion
|
0.02%
2/12692 • Number of events 2
|
0.00%
0/306
|
0.00%
0/40
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.01%
3/21177 • Number of events 3
|
0.00%
0/306
|
0.00%
0/40
|
|
Respiratory, thoracic and mediastinal disorders
Adenoidal hypertrophy
|
0.02%
5/21177 • Number of events 6
|
0.00%
0/306
|
0.00%
0/40
|
|
Respiratory, thoracic and mediastinal disorders
Allergic respiratory symptom
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.00%
1/21177 • Number of events 2
|
0.00%
0/306
|
0.00%
0/40
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.01%
2/21177 • Number of events 2
|
0.00%
0/306
|
0.00%
0/40
|
|
Respiratory, thoracic and mediastinal disorders
Asthmatic crisis
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.01%
2/21177 • Number of events 2
|
0.00%
0/306
|
0.00%
0/40
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.01%
2/21177 • Number of events 2
|
0.00%
0/306
|
0.00%
0/40
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Respiratory, thoracic and mediastinal disorders
Nasal obstruction
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.01%
3/21177 • Number of events 5
|
0.00%
0/306
|
0.00%
0/40
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary arterial hypertension
|
0.01%
2/21177 • Number of events 2
|
0.00%
0/306
|
0.00%
0/40
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary artery dilatation
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.01%
2/21177 • Number of events 2
|
0.00%
0/306
|
0.00%
0/40
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
1/21177 • Number of events 1
|
0.33%
1/306 • Number of events 1
|
0.00%
0/40
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.01%
3/21177 • Number of events 3
|
0.00%
0/306
|
0.00%
0/40
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.02%
4/21177 • Number of events 5
|
0.00%
0/306
|
0.00%
0/40
|
|
Respiratory, thoracic and mediastinal disorders
Snoring
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar haemorrhage
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
0.02%
4/21177 • Number of events 5
|
0.00%
0/306
|
0.00%
0/40
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Skin and subcutaneous tissue disorders
Purpura fulminans
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Social circumstances
Puberty
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Surgical and medical procedures
Adenoidectomy
|
0.01%
3/21177 • Number of events 3
|
0.00%
0/306
|
0.00%
0/40
|
|
Surgical and medical procedures
Adenotonsillectomy
|
0.01%
2/21177 • Number of events 2
|
0.00%
0/306
|
0.00%
0/40
|
|
Surgical and medical procedures
Arthrodesis
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Surgical and medical procedures
Bone marrow transplant
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Surgical and medical procedures
Cleft lip repair
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Surgical and medical procedures
Ear operation
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Surgical and medical procedures
Eye operation
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Surgical and medical procedures
Hydrocele operation
|
0.01%
1/12692 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Surgical and medical procedures
Inguinal hernia repair
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Surgical and medical procedures
Jejunostomy
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Surgical and medical procedures
Leg amputation
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Surgical and medical procedures
Limb operation
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Surgical and medical procedures
Medical device implantation
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Surgical and medical procedures
Meningioma surgery
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Surgical and medical procedures
Nasal septal operation
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Surgical and medical procedures
Oesophagogastric fundoplasty
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Surgical and medical procedures
Oophorectomy bilateral
|
0.01%
1/8458 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Surgical and medical procedures
Orchidectomy
|
0.01%
1/12692 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Surgical and medical procedures
Orchidopexy
|
0.02%
2/12692 • Number of events 2
|
0.00%
0/306
|
0.00%
0/40
|
|
Surgical and medical procedures
Osteotomy
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Surgical and medical procedures
Renal transplant
|
0.01%
2/21177 • Number of events 2
|
0.00%
0/306
|
0.00%
0/40
|
|
Surgical and medical procedures
Salpingo-oophorectomy bilateral
|
0.01%
1/8458 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Surgical and medical procedures
Scoliosis surgery
|
0.01%
2/21177 • Number of events 3
|
0.00%
0/306
|
0.00%
0/40
|
|
Surgical and medical procedures
Spinal fusion surgery
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Surgical and medical procedures
Tenotomy
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Surgical and medical procedures
Tonsillectomy
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Surgical and medical procedures
Ventriculo-peritoneal shunt
|
0.01%
2/21177 • Number of events 2
|
0.00%
0/306
|
0.00%
0/40
|
|
Surgical and medical procedures
Wisdom teeth removal
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Vascular disorders
Angiodysplasia
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Vascular disorders
Aortic stenosis
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
|
Vascular disorders
Hypertension
|
0.01%
2/21177 • Number of events 2
|
0.00%
0/306
|
0.00%
0/40
|
|
Vascular disorders
Vasculitis
|
0.00%
1/21177 • Number of events 1
|
0.00%
0/306
|
0.00%
0/40
|
Other adverse events
| Measure |
Treated
n=21177 participants at risk
Treatment with Humatrope for improvement of growth.
|
Untreated
n=306 participants at risk
No treatment with somatropin in participants with a history of neoplasia or in those with any SHOX deficiency-related disorder.
|
n=40 participants at risk
Treatment with Humatrope unknown.
|
|---|---|---|---|
|
Congenital, familial and genetic disorders
Turner's syndrome
|
0.22%
19/8458 • Number of events 19
|
0.00%
0/306
|
0.00%
0/40
|
|
Endocrine disorders
Adrenal insufficiency
|
0.47%
99/21177 • Number of events 100
|
0.98%
3/306 • Number of events 3
|
0.00%
0/40
|
|
Endocrine disorders
Autoimmune thyroiditis
|
0.23%
48/21177 • Number of events 50
|
0.65%
2/306 • Number of events 2
|
0.00%
0/40
|
|
Endocrine disorders
Delayed puberty
|
0.91%
192/21177 • Number of events 193
|
0.98%
3/306 • Number of events 3
|
0.00%
0/40
|
|
Endocrine disorders
Diabetes insipidus
|
0.23%
49/21177 • Number of events 49
|
0.33%
1/306 • Number of events 1
|
0.00%
0/40
|
|
Endocrine disorders
Hypogonadism
|
0.61%
129/21177 • Number of events 131
|
0.00%
0/306
|
0.00%
0/40
|
|
Endocrine disorders
Hypopituitarism
|
0.40%
85/21177 • Number of events 85
|
0.00%
0/306
|
0.00%
0/40
|
|
Endocrine disorders
Hypothyroidism
|
1.8%
391/21177 • Number of events 391
|
0.65%
2/306 • Number of events 2
|
0.00%
0/40
|
|
Endocrine disorders
Precocious puberty
|
1.2%
262/21177 • Number of events 266
|
3.6%
11/306 • Number of events 11
|
0.00%
0/40
|
|
Endocrine disorders
Primary hypothyroidism
|
0.91%
193/21177 • Number of events 195
|
2.3%
7/306 • Number of events 7
|
0.00%
0/40
|
|
Endocrine disorders
Secondary hypogonadism
|
0.46%
97/21177 • Number of events 97
|
1.3%
4/306 • Number of events 4
|
0.00%
0/40
|
|
Endocrine disorders
Secondary hypothyroidism
|
1.5%
312/21177 • Number of events 314
|
0.33%
1/306 • Number of events 1
|
0.00%
0/40
|
|
Gastrointestinal disorders
Abdominal pain
|
0.63%
133/21177 • Number of events 147
|
3.6%
11/306 • Number of events 16
|
0.00%
0/40
|
|
Gastrointestinal disorders
Constipation
|
0.69%
147/21177 • Number of events 153
|
4.2%
13/306 • Number of events 17
|
0.00%
0/40
|
|
Gastrointestinal disorders
Diarrhoea
|
0.33%
69/21177 • Number of events 74
|
4.2%
13/306 • Number of events 14
|
0.00%
0/40
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.27%
57/21177 • Number of events 58
|
0.00%
0/306
|
0.00%
0/40
|
|
Gastrointestinal disorders
Nausea
|
0.31%
65/21177 • Number of events 71
|
3.9%
12/306 • Number of events 17
|
0.00%
0/40
|
|
Gastrointestinal disorders
Vomiting
|
0.54%
115/21177 • Number of events 138
|
1.6%
5/306 • Number of events 6
|
0.00%
0/40
|
|
General disorders
Asthenia
|
0.25%
53/21177 • Number of events 55
|
0.00%
0/306
|
0.00%
0/40
|
|
General disorders
Fatigue
|
0.34%
73/21177 • Number of events 77
|
4.6%
14/306 • Number of events 16
|
0.00%
0/40
|
|
General disorders
Injection site pain
|
0.25%
53/21177 • Number of events 55
|
0.00%
0/306
|
0.00%
0/40
|
|
General disorders
No adverse event
|
0.52%
110/21177 • Number of events 110
|
0.00%
0/306
|
0.00%
0/40
|
|
General disorders
Pyrexia
|
0.56%
118/21177 • Number of events 148
|
1.6%
5/306 • Number of events 12
|
0.00%
0/40
|
|
Immune system disorders
Hypersensitivity
|
0.21%
44/21177 • Number of events 45
|
0.00%
0/306
|
0.00%
0/40
|
|
Immune system disorders
Multiple allergies
|
0.33%
70/21177 • Number of events 70
|
0.00%
0/306
|
0.00%
0/40
|
|
Immune system disorders
Seasonal allergy
|
0.47%
99/21177 • Number of events 104
|
2.3%
7/306 • Number of events 7
|
0.00%
0/40
|
|
Infections and infestations
Bronchitis
|
0.42%
90/21177 • Number of events 112
|
0.65%
2/306 • Number of events 3
|
0.00%
0/40
|
|
Infections and infestations
Ear infection
|
0.33%
70/21177 • Number of events 89
|
0.65%
2/306 • Number of events 2
|
0.00%
0/40
|
|
Infections and infestations
Gastroenteritis
|
0.58%
123/21177 • Number of events 140
|
1.6%
5/306 • Number of events 5
|
0.00%
0/40
|
|
Infections and infestations
Influenza
|
0.51%
108/21177 • Number of events 131
|
1.3%
4/306 • Number of events 5
|
0.00%
0/40
|
|
Infections and infestations
Nasopharyngitis
|
0.37%
78/21177 • Number of events 108
|
0.00%
0/306
|
0.00%
0/40
|
|
Infections and infestations
Otitis media
|
0.94%
199/21177 • Number of events 264
|
3.3%
10/306 • Number of events 15
|
0.00%
0/40
|
|
Infections and infestations
Pharyngitis
|
0.24%
51/21177 • Number of events 55
|
0.00%
0/306
|
0.00%
0/40
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.33%
70/21177 • Number of events 82
|
1.3%
4/306 • Number of events 5
|
0.00%
0/40
|
|
Infections and infestations
Pneumonia
|
0.29%
62/21177 • Number of events 74
|
0.98%
3/306 • Number of events 4
|
0.00%
0/40
|
|
Infections and infestations
Sinusitis
|
0.47%
99/21177 • Number of events 111
|
2.6%
8/306 • Number of events 10
|
0.00%
0/40
|
|
Infections and infestations
Upper respiratory tract infection
|
0.94%
199/21177 • Number of events 279
|
6.5%
20/306 • Number of events 33
|
0.00%
0/40
|
|
Infections and infestations
Urinary tract infection
|
0.23%
49/21177 • Number of events 58
|
1.3%
4/306 • Number of events 5
|
0.00%
0/40
|
|
Infections and infestations
Varicella
|
0.20%
43/21177 • Number of events 44
|
0.33%
1/306 • Number of events 1
|
0.00%
0/40
|
|
Investigations
Blood corticotrophin decreased
|
0.24%
51/21177 • Number of events 51
|
0.00%
0/306
|
0.00%
0/40
|
|
Metabolism and nutrition disorders
Obesity
|
0.30%
64/21177 • Number of events 66
|
1.6%
5/306 • Number of events 5
|
0.00%
0/40
|
|
Metabolism and nutrition disorders
Vitamin d deficiency
|
0.64%
135/21177 • Number of events 143
|
11.8%
36/306 • Number of events 40
|
0.00%
0/40
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.8%
373/21177 • Number of events 425
|
5.2%
16/306 • Number of events 23
|
0.00%
0/40
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.41%
87/21177 • Number of events 92
|
2.3%
7/306 • Number of events 7
|
0.00%
0/40
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.25%
52/21177 • Number of events 52
|
0.33%
1/306 • Number of events 1
|
0.00%
0/40
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.27%
58/21177 • Number of events 59
|
2.3%
7/306 • Number of events 7
|
0.00%
0/40
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.52%
111/21177 • Number of events 128
|
3.3%
10/306 • Number of events 17
|
0.00%
0/40
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
1.9%
412/21177 • Number of events 416
|
2.6%
8/306 • Number of events 8
|
0.00%
0/40
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.61%
129/21177 • Number of events 134
|
1.6%
5/306 • Number of events 5
|
0.00%
0/40
|
|
Nervous system disorders
Dizziness
|
0.20%
43/21177 • Number of events 45
|
2.0%
6/306 • Number of events 11
|
0.00%
0/40
|
|
Nervous system disorders
Headache
|
2.8%
594/21177 • Number of events 680
|
11.8%
36/306 • Number of events 67
|
0.00%
0/40
|
|
Nervous system disorders
Migraine
|
0.30%
63/21177 • Number of events 64
|
0.00%
0/306
|
0.00%
0/40
|
|
Nervous system disorders
Seizure
|
0.41%
87/21177 • Number of events 89
|
1.3%
4/306 • Number of events 4
|
0.00%
0/40
|
|
Psychiatric disorders
Abnormal behaviour
|
0.20%
43/21177 • Number of events 43
|
0.33%
1/306 • Number of events 1
|
0.00%
0/40
|
|
Psychiatric disorders
Anxiety
|
0.31%
65/21177 • Number of events 65
|
3.3%
10/306 • Number of events 10
|
0.00%
0/40
|
|
Psychiatric disorders
Attention deficit/hyperactivity disorder
|
1.8%
389/21177 • Number of events 389
|
1.6%
5/306 • Number of events 5
|
0.00%
0/40
|
|
Psychiatric disorders
Depression
|
0.38%
81/21177 • Number of events 81
|
0.33%
1/306 • Number of events 1
|
0.00%
0/40
|
|
Psychiatric disorders
Insomnia
|
0.22%
47/21177 • Number of events 48
|
1.3%
4/306 • Number of events 4
|
0.00%
0/40
|
|
Renal and urinary disorders
Enuresis
|
0.45%
95/21177 • Number of events 101
|
0.65%
2/306 • Number of events 2
|
0.00%
0/40
|
|
Reproductive system and breast disorders
Amenorrhoea
|
0.25%
21/8458 • Number of events 21
|
0.60%
1/166 • Number of events 1
|
0.00%
0/40
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.19%
16/8458 • Number of events 16
|
2.4%
4/166 • Number of events 6
|
0.00%
0/40
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.69%
87/12692 • Number of events 89
|
0.00%
0/306
|
0.00%
0/40
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.27%
23/8458 • Number of events 23
|
1.2%
2/166 • Number of events 2
|
0.00%
0/40
|
|
Reproductive system and breast disorders
Ovarian failure
|
1.0%
85/8458 • Number of events 85
|
4.2%
7/166 • Number of events 7
|
0.00%
0/40
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.82%
174/21177 • Number of events 180
|
0.65%
2/306 • Number of events 2
|
0.00%
0/40
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.33%
70/21177 • Number of events 75
|
1.6%
5/306 • Number of events 6
|
0.00%
0/40
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.18%
38/21177 • Number of events 40
|
2.0%
6/306 • Number of events 9
|
0.00%
0/40
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.29%
61/21177 • Number of events 69
|
0.00%
0/306
|
0.00%
0/40
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.26%
55/21177 • Number of events 55
|
0.33%
1/306 • Number of events 1
|
0.00%
0/40
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.61%
130/21177 • Number of events 135
|
1.6%
5/306 • Number of events 5
|
0.00%
0/40
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.34%
73/21177 • Number of events 75
|
0.65%
2/306 • Number of events 2
|
0.00%
0/40
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.22%
47/21177 • Number of events 48
|
2.3%
7/306 • Number of events 9
|
0.00%
0/40
|
|
Vascular disorders
Hypertension
|
0.21%
45/21177 • Number of events 47
|
1.6%
5/306 • Number of events 5
|
0.00%
0/40
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60