Trial Outcomes & Findings for Growth Hormone Treatment in Children Born Small for Gestational Age (SGA) (NCT NCT00184717)
NCT ID: NCT00184717
Last Updated: 2017-07-07
Results Overview
Height SDS for chronological age were derived as follow; {Height - mean (age, sex)}/ SD (age, sex), where mean (age, sex) and SD (age, sex) were mean and SD of height for corresponding chronological age and sex (data of those in 2000). Height SDS was calculated using mean of three height observations at corresponding visit
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
98 participants
Primary outcome timeframe
Week 0, week 260
Results posted on
2017-07-07
Participant Flow
44 sites in Japan
Subjects completed the main period and were offered to continue in the extension period.
Participant milestones
| Measure |
0.033 mg / NN-220
In the 156-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
|
0.067 mg / NN-220
In the 156-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
|
No Treatment
No somatropin (NN-220) treatment was given in the 52-week main period. Subjects was re-randomised to recive two dosing regimens (0.033 mg/kg/day or 0.067 mg/kg/day) in the 208-week extension period
|
No Treatment --> 0.033 mg
In the 208-week extension period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
|
No Treatment --> 0.067 mg
In the 208-week extension period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
|
|---|---|---|---|---|---|
|
Main Period (GHLIQUID-1516)
STARTED
|
39
|
38
|
21
|
0
|
0
|
|
Main Period (GHLIQUID-1516)
Exposed to Trial Drug
|
38
|
38
|
21
|
0
|
0
|
|
Main Period (GHLIQUID-1516)
COMPLETED
|
36
|
36
|
20
|
0
|
0
|
|
Main Period (GHLIQUID-1516)
NOT COMPLETED
|
3
|
2
|
1
|
0
|
0
|
|
Extension Period (GHLIQUID-1517)
STARTED
|
33
|
33
|
0
|
10
|
10
|
|
Extension Period (GHLIQUID-1517)
COMPLETED
|
23
|
27
|
0
|
7
|
5
|
|
Extension Period (GHLIQUID-1517)
NOT COMPLETED
|
10
|
6
|
0
|
3
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Growth Hormone Treatment in Children Born Small for Gestational Age (SGA)
Baseline characteristics by cohort
| Measure |
0.033 mg / NN-220
n=35 Participants
In the 156-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
|
0.067 mg / NN-220
n=34 Participants
In the 156-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
|
No Treatment
n=15 Participants
No somatropin (NN-220) treatment was given in the 52-week main period. Subjects was re-randomised to recive two dosing regimens (0.033 mg/kg/day or 0.067 mg/kg/day) in the 208-week extension period
|
Total
n=84 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
5.46 years
STANDARD_DEVIATION 1.37 • n=5 Participants
|
5.15 years
STANDARD_DEVIATION 1.2 • n=7 Participants
|
5.09 years
STANDARD_DEVIATION 1.37 • n=5 Participants
|
5.27 years
STANDARD_DEVIATION 1.3 • n=4 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
84 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
35 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
84 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
Japan
|
35 participants
n=5 Participants
|
34 participants
n=7 Participants
|
15 participants
n=5 Participants
|
84 participants
n=4 Participants
|
|
Height
|
96.19 cm
STANDARD_DEVIATION 8.48 • n=5 Participants
|
94.57 cm
STANDARD_DEVIATION 7.28 • n=7 Participants
|
94.42 cm
STANDARD_DEVIATION 8.48 • n=5 Participants
|
95.22 cm
STANDARD_DEVIATION 7.96 • n=4 Participants
|
|
Body weight
|
13.31 kg
STANDARD_DEVIATION 2.55 • n=5 Participants
|
12.62 kg
STANDARD_DEVIATION 1.81 • n=7 Participants
|
12.47 kg
STANDARD_DEVIATION 2.93 • n=5 Participants
|
12.88 kg
STANDARD_DEVIATION 2.36 • n=4 Participants
|
PRIMARY outcome
Timeframe: Week 0, week 260Population: Endpoint Analysis Set (EAS) consisted of subjects who participated in GHLIQUID-1517 in the Full Analysis Set (FAS). FAS consisted of subjects who were randomised in each group and have any available efficacy data after receiving NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP (Good Clinical Practice) nonconformity
Height SDS for chronological age were derived as follow; {Height - mean (age, sex)}/ SD (age, sex), where mean (age, sex) and SD (age, sex) were mean and SD of height for corresponding chronological age and sex (data of those in 2000). Height SDS was calculated using mean of three height observations at corresponding visit
Outcome measures
| Measure |
0.033 mg / NN-220
n=28 Participants
In the 156-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
|
0.067 mg / NN-220
n=29 Participants
In the 156-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
|
No Treatment --> 0.033 mg
In the 208-week extension period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
|
No Treatment --> 0.067 mg
In the 208-week extension period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
|
|---|---|---|---|---|
|
Change in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Week 260 - Subjects Received NN220 Treatment for 5 Years
Week 0
|
-2.9488 Standard Deviation Score (SDS)
Standard Error 0.6368
|
-2.9047 Standard Deviation Score (SDS)
Standard Error 0.6718
|
—
|
—
|
|
Change in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Week 260 - Subjects Received NN220 Treatment for 5 Years
Week 260
|
1.2066 Standard Deviation Score (SDS)
Standard Error 0.1102
|
2.0247 Standard Deviation Score (SDS)
Standard Error 0.1083
|
—
|
—
|
PRIMARY outcome
Timeframe: Week 0, week 208Population: Endpoint Analysis Set (EAS) consisted of subjects who participated in GHLIQUID-1517 in the Full Analysis Set (FAS). FAS consisted of subjects who were randomised in each group and have any available efficacy data after receiving NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP (Good Clinical Practice) nonconformity
Height SDS for chronological age were derived as follow; {Height - mean (age, sex)}/ SD (age, sex), where mean (age, sex) and SD (age, sex) were mean and SD of height for corresponding chronological age and sex (data of those in 2000). Height SDS was calculated using mean of three height observations at corresponding visit
Outcome measures
| Measure |
0.033 mg / NN-220
In the 156-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
|
0.067 mg / NN-220
In the 156-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
|
No Treatment --> 0.033 mg
n=7 Participants
In the 208-week extension period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
|
No Treatment --> 0.067 mg
n=8 Participants
In the 208-week extension period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
|
|---|---|---|---|---|
|
Change in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Week 208 - Subjects Received NN220 Treatment for 4 Years
Week 0
|
—
|
—
|
-2.9603 Standard Deviation Score (SDS)
Standard Error 0.6689
|
-2.7481 Standard Deviation Score (SDS)
Standard Error 0.3524
|
|
Change in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Week 208 - Subjects Received NN220 Treatment for 4 Years
Week 208
|
—
|
—
|
1.0997 Standard Deviation Score (SDS)
Standard Error 0.2453
|
1.9151 Standard Deviation Score (SDS)
Standard Error 0.2275
|
SECONDARY outcome
Timeframe: Weeks 0-260Population: Endpoint Analysis Set (EAS) consisted of subjects who participated in GHLIQUID-1517 in the Full Analysis Set (FAS). FAS consisted of subjects who were randomised in each group and have any available efficacy data after receiving NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP (Good Clinical Practice) nonconformity
Yearly Height velocity SDS for chronological age were summarised and graphically presented
Outcome measures
| Measure |
0.033 mg / NN-220
n=31 Participants
In the 156-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
|
0.067 mg / NN-220
n=34 Participants
In the 156-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
|
No Treatment --> 0.033 mg
In the 208-week extension period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
|
No Treatment --> 0.067 mg
In the 208-week extension period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
|
|---|---|---|---|---|
|
Yearly Height Velocity SDS for Chronological Age - Subjects Received NN220 Treatment for 5 Years
Baseline, n=31, 34
|
-1.6299 Standard Deviation Score (SDS)
Standard Deviation 0.9738
|
-2.0303 Standard Deviation Score (SDS)
Standard Deviation 1.4527
|
—
|
—
|
|
Yearly Height Velocity SDS for Chronological Age - Subjects Received NN220 Treatment for 5 Years
Week 52, n=29, 34
|
2.4717 Standard Deviation Score (SDS)
Standard Deviation 1.9848
|
4.7875 Standard Deviation Score (SDS)
Standard Deviation 1.9365
|
—
|
—
|
|
Yearly Height Velocity SDS for Chronological Age - Subjects Received NN220 Treatment for 5 Years
Week 104, n=29, 32
|
1.1344 Standard Deviation Score (SDS)
Standard Deviation 1.2782
|
2.8877 Standard Deviation Score (SDS)
Standard Deviation 1.1272
|
—
|
—
|
|
Yearly Height Velocity SDS for Chronological Age - Subjects Received NN220 Treatment for 5 Years
Week 156, n=25, 29
|
0.8015 Standard Deviation Score (SDS)
Standard Deviation 1.0583
|
2.1641 Standard Deviation Score (SDS)
Standard Deviation 1.5929
|
—
|
—
|
|
Yearly Height Velocity SDS for Chronological Age - Subjects Received NN220 Treatment for 5 Years
Week 208, n=25, 28
|
0.3991 Standard Deviation Score (SDS)
Standard Deviation 1.3006
|
1.4724 Standard Deviation Score (SDS)
Standard Deviation 1.8696
|
—
|
—
|
|
Yearly Height Velocity SDS for Chronological Age - Subjects Received NN220 Treatment for 5 Years
Week 260, n=23, 27
|
0.4612 Standard Deviation Score (SDS)
Standard Deviation 2.1558
|
0.7973 Standard Deviation Score (SDS)
Standard Deviation 2.1822
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 0-208Population: Endpoint Analysis Set (EAS) consisted of subjects who participated in GHLIQUID-1517 in the Full Analysis Set (FAS). FAS consisted of subjects who were randomised in each group and have any available efficacy data after receiving NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP (Good Clinical Practice) nonconformity
Yearly Height velocity SDS for chronological age were summarised and graphically presented
Outcome measures
| Measure |
0.033 mg / NN-220
In the 156-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
|
0.067 mg / NN-220
In the 156-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
|
No Treatment --> 0.033 mg
n=7 Participants
In the 208-week extension period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
|
No Treatment --> 0.067 mg
n=8 Participants
In the 208-week extension period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
|
|---|---|---|---|---|
|
Yearly Height Velocity SDS for Chronological Age - Subjects Received NN220 Treatment for 4 Years
Baseline, n=7,8
|
—
|
—
|
0.073 Standard Deviation Score (SDS)
Standard Deviation 1.5681
|
-1.356 Standard Deviation Score (SDS)
Standard Deviation 0.708
|
|
Yearly Height Velocity SDS for Chronological Age - Subjects Received NN220 Treatment for 4 Years
Week 52, n=7, 8
|
—
|
—
|
2.1677 Standard Deviation Score (SDS)
Standard Deviation 0.61
|
5.9303 Standard Deviation Score (SDS)
Standard Deviation 1.2096
|
|
Yearly Height Velocity SDS for Chronological Age - Subjects Received NN220 Treatment for 4 Years
Week 104, n=6, 7
|
—
|
—
|
1.5268 Standard Deviation Score (SDS)
Standard Deviation 1.1715
|
3.3979 Standard Deviation Score (SDS)
Standard Deviation 1.0542
|
|
Yearly Height Velocity SDS for Chronological Age - Subjects Received NN220 Treatment for 4 Years
Week 156, n=6, 7
|
—
|
—
|
1.7617 Standard Deviation Score (SDS)
Standard Deviation 2.0956
|
2.3539 Standard Deviation Score (SDS)
Standard Deviation 1.3149
|
|
Yearly Height Velocity SDS for Chronological Age - Subjects Received NN220 Treatment for 4 Years
Week 208, n=6, 6
|
—
|
—
|
0.5475 Standard Deviation Score (SDS)
Standard Deviation 1.6055
|
2.199 Standard Deviation Score (SDS)
Standard Deviation 1.5973
|
SECONDARY outcome
Timeframe: Week 0, week 260Population: Endpoint Analysis Set (EAS) consisted of subjects who participated in GHLIQUID-1517 in the Full Analysis Set (FAS). FAS consisted of subjects who were randomised in each group and have any available efficacy data after receiving NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP (Good Clinical Practice) nonconformity
Bone age is measured as years and months (displayed as xx.x years). Change in Bone age = Bone age at 52\*i weeks - Bone age at 52\*(i-1) weeks, i=1, 2, ….
Outcome measures
| Measure |
0.033 mg / NN-220
n=21 Participants
In the 156-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
|
0.067 mg / NN-220
n=26 Participants
In the 156-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
|
No Treatment --> 0.033 mg
In the 208-week extension period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
|
No Treatment --> 0.067 mg
In the 208-week extension period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
|
|---|---|---|---|---|
|
Change in Bone Age (Left Hand X-Ray) at Week 260 - Subjects Received NN220 Treatment for 5 Years
|
5.79 years
Standard Deviation 1.05
|
7.15 years
Standard Deviation 1.05
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0, week 208Population: Endpoint Analysis Set (EAS) consisted of subjects who participated in GHLIQUID-1517 in the Full Analysis Set (FAS). FAS consisted of subjects who were randomised in each group and have any available efficacy data after receiving NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP (Good Clinical Practice) nonconformity
Bone age is measured as years and months (displayed as xx.x years).Change in Bone age = Bone age at 52\*i weeks - Bone age at 52\*(i-1) weeks, i=1, 2, ….
Outcome measures
| Measure |
0.033 mg / NN-220
In the 156-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
|
0.067 mg / NN-220
In the 156-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
|
No Treatment --> 0.033 mg
n=5 Participants
In the 208-week extension period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
|
No Treatment --> 0.067 mg
n=6 Participants
In the 208-week extension period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
|
|---|---|---|---|---|
|
Change in Bone Age (Left Hand X-Ray) at Week 208 - Subjects Received NN220 Treatment for 4 Years
|
—
|
—
|
6.54 years
Standard Deviation 1.26
|
5.6 years
Standard Deviation 1.68
|
SECONDARY outcome
Timeframe: Weeks 0-260Population: Safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP (Good Clinical Practice) nonconformity
Occurrence of Adverse Events (AEs) during treatment period (TEAEs), occurrence of possibly/probably related AEs during the treatment period, and occurrence of Serious Adverse Events (SAEs) during the treatment period. An AE is any undesirable medical event occurring to a subject in a clinical trial, whether or not related to the trial product(s). An SAE is an experience that at any dose is fatal, life-threatening, disabling or which results in the patient being hospitalised or, if already in hospital, that hospitalisation is prolonged, or ocurrence of congenital anomaly
Outcome measures
| Measure |
0.033 mg / NN-220
n=31 Participants
In the 156-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
|
0.067 mg / NN-220
n=34 Participants
In the 156-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
|
No Treatment --> 0.033 mg
In the 208-week extension period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
|
No Treatment --> 0.067 mg
In the 208-week extension period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
|
|---|---|---|---|---|
|
Adverse Events - Subjects Received NN220 Treatment for 5 Years
AEs
|
31 Subjects
|
34 Subjects
|
—
|
—
|
|
Adverse Events - Subjects Received NN220 Treatment for 5 Years
AEs possibly/probably related
|
9 Subjects
|
16 Subjects
|
—
|
—
|
|
Adverse Events - Subjects Received NN220 Treatment for 5 Years
SAEs
|
2 Subjects
|
4 Subjects
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 0-208Population: Safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP (Good Clinical Practice) nonconformity
Occurrence of Adverse Events (AEs) during treatment period (TEAEs), occurrence of possibly/probably related AEs during the treatment period, and occurrence of Serious Adverse Events (SAEs) during the treatment period. An AE is any undesirable medical event occurring to a subject in a clinical trial, whether or not related to the trial product(s). An SAE is an experience that at any dose is fatal, life-threatening, disabling or which results in the patient being hospitalised or, if already in hospital, that hospitalisation is prolonged, or ocurrence of congenital anomaly
Outcome measures
| Measure |
0.033 mg / NN-220
In the 156-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
|
0.067 mg / NN-220
In the 156-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
|
No Treatment --> 0.033 mg
n=7 Participants
In the 208-week extension period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
|
No Treatment --> 0.067 mg
n=8 Participants
In the 208-week extension period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
|
|---|---|---|---|---|
|
Adverse Events - Subjects Received NN220 Treatment for 4 Years
AEs
|
—
|
—
|
7 Subjects
|
8 Subjects
|
|
Adverse Events - Subjects Received NN220 Treatment for 4 Years
AEs possibly/probably relate
|
—
|
—
|
1 Subjects
|
3 Subjects
|
|
Adverse Events - Subjects Received NN220 Treatment for 4 Years
SAEs
|
—
|
—
|
0 Subjects
|
1 Subjects
|
Adverse Events
0.033 mg / NN-220
Serious events: 12 serious events
Other events: 31 other events
Deaths: 0 deaths
0.067 mg / NN-220
Serious events: 11 serious events
Other events: 34 other events
Deaths: 0 deaths
0.033 mg / No Treatment
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
0.067 mg / No Treatment
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
0.033 mg / NN-220
n=31 participants at risk
|
0.067 mg / NN-220
n=34 participants at risk
|
0.033 mg / No Treatment
n=7 participants at risk
|
0.067 mg / No Treatment
n=8 participants at risk
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Adenoidal hypertrophy
|
3.2%
1/31 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/34 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
12.5%
1/8 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/31 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
2.9%
1/34 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
3.2%
1/31 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
2.9%
1/34 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Infections and infestations
Bronchitis
|
3.2%
1/31 • Number of events 2 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/34 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Infections and infestations
Bronchopneumonia
|
3.2%
1/31 • Number of events 3 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/34 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.00%
0/31 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
2.9%
1/34 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Nervous system disorders
Convulsion
|
6.5%
2/31 • Number of events 2 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/34 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
3.2%
1/31 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/34 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Infections and infestations
Epstein-Barr virus infection
|
3.2%
1/31 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/34 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Nervous system disorders
Febrile convulsion
|
6.5%
2/31 • Number of events 3 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/34 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Infections and infestations
Gastroenteritis rotavirus
|
3.2%
1/31 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/34 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/31 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/34 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
14.3%
1/7 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
12.5%
1/8 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/31 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
2.9%
1/34 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Renal and urinary disorders
IgA nephropathy
|
3.2%
1/31 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/34 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/31 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
2.9%
1/34 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Infections and infestations
Impetigo
|
0.00%
0/31 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/34 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
12.5%
1/8 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Infections and infestations
Influenza
|
3.2%
1/31 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/34 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Gastrointestinal disorders
Inguinal hernia
|
3.2%
1/31 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/34 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
3.2%
1/31 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/34 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/31 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
2.9%
1/34 • Number of events 3 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Infections and infestations
Meningitis aseptic
|
0.00%
0/31 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
5.9%
2/34 • Number of events 2 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Infections and infestations
Mumps
|
0.00%
0/31 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
2.9%
1/34 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Infections and infestations
Otitis media
|
0.00%
0/31 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
2.9%
1/34 • Number of events 2 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Infections and infestations
Pneumonia
|
6.5%
2/31 • Number of events 2 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
2.9%
1/34 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Infections and infestations
Pneumonia mycoplasmal
|
3.2%
1/31 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/34 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Infections and infestations
Postoperative wound infection
|
3.2%
1/31 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/34 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Congenital, familial and genetic disorders
Sebaceous naevus
|
0.00%
0/31 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
2.9%
1/34 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
3.2%
1/31 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/34 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Eye disorders
Strabismus
|
6.5%
2/31 • Number of events 2 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
2.9%
1/34 • Number of events 2 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Infections and infestations
Streptococcal infection
|
0.00%
0/31 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
2.9%
1/34 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Reproductive system and breast disorders
Testicular retraction
|
3.2%
1/31 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/34 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar disorder
|
3.2%
1/31 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/34 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
6.5%
2/31 • Number of events 2 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/34 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
12.5%
1/8 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Musculoskeletal and connective tissue disorders
Torticollis
|
3.2%
1/31 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/34 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Infections and infestations
Tracheobronchitis mycoplasmal
|
3.2%
1/31 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/34 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/31 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
2.9%
1/34 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
0.00%
0/31 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
2.9%
1/34 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
Other adverse events
| Measure |
0.033 mg / NN-220
n=31 participants at risk
|
0.067 mg / NN-220
n=34 participants at risk
|
0.033 mg / No Treatment
n=7 participants at risk
|
0.067 mg / No Treatment
n=8 participants at risk
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
12.9%
4/31 • Number of events 4 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
5.9%
2/34 • Number of events 3 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/31 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
8.8%
3/34 • Number of events 4 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Infections and infestations
Acute sinusitis
|
3.2%
1/31 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
5.9%
2/34 • Number of events 8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
12.5%
1/8 • Number of events 2 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Infections and infestations
Acute tonsillitis
|
6.5%
2/31 • Number of events 2 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
11.8%
4/34 • Number of events 11 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Infections and infestations
Adenoviral conjunctivitis
|
3.2%
1/31 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/34 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
12.5%
1/8 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Infections and infestations
Adenovirus infection
|
0.00%
0/31 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
2.9%
1/34 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
12.5%
1/8 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Investigations
Alanine aminotransferase increased
|
3.2%
1/31 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
2.9%
1/34 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
14.3%
1/7 • Number of events 2 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
12.5%
1/8 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Investigations
Antibody test positive
|
0.00%
0/31 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
5.9%
2/34 • Number of events 2 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.2%
1/31 • Number of events 3 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
17.6%
6/34 • Number of events 10 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
14.3%
1/7 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
3.2%
1/31 • Number of events 2 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
5.9%
2/34 • Number of events 2 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
28.6%
2/7 • Number of events 2 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/31 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/34 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
14.3%
1/7 • Number of events 2 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
12.5%
1/8 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
22.6%
7/31 • Number of events 11 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
14.7%
5/34 • Number of events 26 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
14.3%
1/7 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
25.0%
2/8 • Number of events 2 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Eye disorders
Astigmatism
|
0.00%
0/31 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
2.9%
1/34 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
14.3%
1/7 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
12.5%
1/8 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Infections and infestations
Beta haemolytic streptococcal infection
|
12.9%
4/31 • Number of events 5 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
11.8%
4/34 • Number of events 5 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
12.5%
1/8 • Number of events 2 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Investigations
Blood urine present
|
0.00%
0/31 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
5.9%
2/34 • Number of events 2 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Infections and infestations
Bronchitis
|
45.2%
14/31 • Number of events 66 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
44.1%
15/34 • Number of events 66 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
75.0%
6/8 • Number of events 19 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Injury, poisoning and procedural complications
Chillblains
|
3.2%
1/31 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
5.9%
2/34 • Number of events 2 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
14.3%
1/7 • Number of events 2 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/31 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
5.9%
2/34 • Number of events 3 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Eye disorders
Conjunctival hyperaemia
|
6.5%
2/31 • Number of events 2 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/34 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Eye disorders
Conjunctivitis
|
12.9%
4/31 • Number of events 4 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
20.6%
7/34 • Number of events 13 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
37.5%
3/8 • Number of events 4 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Eye disorders
Conjunctivitis allergic
|
9.7%
3/31 • Number of events 5 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
14.7%
5/34 • Number of events 7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
25.0%
2/8 • Number of events 3 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Gastrointestinal disorders
Constipation
|
19.4%
6/31 • Number of events 8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
14.7%
5/34 • Number of events 7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
25.0%
2/8 • Number of events 3 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Injury, poisoning and procedural complications
Contusion
|
3.2%
1/31 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
17.6%
6/34 • Number of events 7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
25.0%
2/8 • Number of events 2 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Nervous system disorders
Convulsion
|
6.5%
2/31 • Number of events 4 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/34 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.5%
2/31 • Number of events 2 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
11.8%
4/34 • Number of events 7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
14.3%
1/7 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
12.5%
1/8 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Musculoskeletal and connective tissue disorders
Dactylitis
|
0.00%
0/31 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/34 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
12.5%
1/8 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Gastrointestinal disorders
Dental caries
|
6.5%
2/31 • Number of events 2 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
17.6%
6/34 • Number of events 7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
25.0%
2/8 • Number of events 2 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/31 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
5.9%
2/34 • Number of events 4 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
12.5%
1/8 • Number of events 2 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
9.7%
3/31 • Number of events 3 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
11.8%
4/34 • Number of events 4 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
3.2%
1/31 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
5.9%
2/34 • Number of events 2 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
14.3%
1/7 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
12.5%
1/8 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.5%
2/31 • Number of events 3 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
11.8%
4/34 • Number of events 5 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.5%
2/31 • Number of events 2 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
5.9%
2/34 • Number of events 2 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Gastrointestinal disorders
Dyspepsia
|
3.2%
1/31 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
5.9%
2/34 • Number of events 4 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/31 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
8.8%
3/34 • Number of events 4 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
29.0%
9/31 • Number of events 14 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
29.4%
10/34 • Number of events 24 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
28.6%
2/7 • Number of events 2 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
25.0%
2/8 • Number of events 2 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
6.5%
2/31 • Number of events 2 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
8.8%
3/34 • Number of events 5 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Infections and infestations
Enteritis infectious
|
3.2%
1/31 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
5.9%
2/34 • Number of events 2 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
12.5%
1/8 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Infections and infestations
Enterobiasis
|
12.9%
4/31 • Number of events 5 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/34 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Gastrointestinal disorders
Enterocolitis
|
6.5%
2/31 • Number of events 8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
2.9%
1/34 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Infections and infestations
Enterocolitis viral
|
0.00%
0/31 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
8.8%
3/34 • Number of events 3 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
12.5%
1/8 • Number of events 2 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Renal and urinary disorders
Enuresis
|
6.5%
2/31 • Number of events 2 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/34 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
12.5%
1/8 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/31 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
2.9%
1/34 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
25.0%
2/8 • Number of events 4 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Injury, poisoning and procedural complications
Excoriation
|
6.5%
2/31 • Number of events 2 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
8.8%
3/34 • Number of events 4 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Eye disorders
Eye pain
|
0.00%
0/31 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/34 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
12.5%
1/8 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Eye disorders
Eyelid oedema
|
6.5%
2/31 • Number of events 2 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/34 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
General disorders
Fatigue
|
0.00%
0/31 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/34 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
12.5%
1/8 • Number of events 5 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Nervous system disorders
Febrile convulsion
|
6.5%
2/31 • Number of events 3 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
5.9%
2/34 • Number of events 3 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibromatosis
|
0.00%
0/31 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/34 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
12.5%
1/8 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Infections and infestations
Folliculitis
|
3.2%
1/31 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/34 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
12.5%
1/8 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Immune system disorders
Food allergy
|
0.00%
0/31 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/34 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
12.5%
1/8 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Infections and infestations
Furuncle
|
6.5%
2/31 • Number of events 2 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/34 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Infections and infestations
Gastroenteritis
|
32.3%
10/31 • Number of events 18 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
41.2%
14/34 • Number of events 25 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
12.5%
1/8 • Number of events 2 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Infections and infestations
Gastroenteritis viral
|
35.5%
11/31 • Number of events 20 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
26.5%
9/34 • Number of events 14 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
50.0%
4/8 • Number of events 8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/31 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
5.9%
2/34 • Number of events 2 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Nervous system disorders
Headache
|
12.9%
4/31 • Number of events 4 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
11.8%
4/34 • Number of events 10 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
14.3%
1/7 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
3.2%
1/31 • Number of events 2 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
5.9%
2/34 • Number of events 2 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
25.0%
2/8 • Number of events 4 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Infections and infestations
Herpes simplex
|
3.2%
1/31 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
5.9%
2/34 • Number of events 3 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/31 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
5.9%
2/34 • Number of events 3 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Infections and infestations
Hordeolum
|
6.5%
2/31 • Number of events 2 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
2.9%
1/34 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.00%
0/31 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
5.9%
2/34 • Number of events 2 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Metabolism and nutrition disorders
Hyperinsulinaemia
|
0.00%
0/31 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
5.9%
2/34 • Number of events 2 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
14.3%
1/7 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Infections and infestations
Impetigo
|
19.4%
6/31 • Number of events 9 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
26.5%
9/34 • Number of events 9 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
28.6%
2/7 • Number of events 5 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
12.5%
1/8 • Number of events 2 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Infections and infestations
Infection
|
0.00%
0/31 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/34 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
12.5%
1/8 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Infections and infestations
Influenza
|
51.6%
16/31 • Number of events 30 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
73.5%
25/34 • Number of events 39 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
85.7%
6/7 • Number of events 7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
50.0%
4/8 • Number of events 7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
3.2%
1/31 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/34 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
14.3%
1/7 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
6.5%
2/31 • Number of events 2 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/34 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.00%
0/31 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
8.8%
3/34 • Number of events 3 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
14.3%
1/7 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
12.5%
1/8 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
3.2%
1/31 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
14.7%
5/34 • Number of events 5 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Infections and infestations
Lymphadenitis bacterial
|
0.00%
0/31 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/34 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
14.3%
1/7 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/31 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
5.9%
2/34 • Number of events 2 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Infections and infestations
Molluscum contagiosum
|
6.5%
2/31 • Number of events 2 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
11.8%
4/34 • Number of events 4 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Ear and labyrinth disorders
Motion sickness
|
3.2%
1/31 • Number of events 5 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
5.9%
2/34 • Number of events 2 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Infections and infestations
Mumps
|
16.1%
5/31 • Number of events 5 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
17.6%
6/34 • Number of events 6 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
14.3%
1/7 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
12.5%
1/8 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Eye disorders
Myopia
|
3.2%
1/31 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
5.9%
2/34 • Number of events 2 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
14.3%
1/7 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Infections and infestations
Nasopharyngitis
|
61.3%
19/31 • Number of events 66 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
79.4%
27/34 • Number of events 212 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
85.7%
6/7 • Number of events 38 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
62.5%
5/8 • Number of events 20 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/31 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/34 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
12.5%
1/8 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.5%
2/31 • Number of events 2 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/34 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
12.5%
1/8 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Infections and infestations
Otitis externa
|
6.5%
2/31 • Number of events 2 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
5.9%
2/34 • Number of events 2 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
14.3%
1/7 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
25.0%
2/8 • Number of events 2 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Infections and infestations
Otitis media
|
22.6%
7/31 • Number of events 11 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
35.3%
12/34 • Number of events 17 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
14.3%
1/7 • Number of events 11 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
37.5%
3/8 • Number of events 12 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Infections and infestations
Otitis media acute
|
12.9%
4/31 • Number of events 13 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
11.8%
4/34 • Number of events 6 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
14.3%
1/7 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
12.5%
1/8 • Number of events 2 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.7%
3/31 • Number of events 3 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
8.8%
3/34 • Number of events 7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
14.3%
1/7 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
12.5%
1/8 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Infections and infestations
Parotitis
|
3.2%
1/31 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
2.9%
1/34 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
14.3%
1/7 • Number of events 3 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Infections and infestations
Pharyngitis
|
25.8%
8/31 • Number of events 46 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
41.2%
14/34 • Number of events 74 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
28.6%
2/7 • Number of events 8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
37.5%
3/8 • Number of events 9 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Infections and infestations
Pneumonia mycoplasmal
|
6.5%
2/31 • Number of events 2 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
2.9%
1/34 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/31 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
5.9%
2/34 • Number of events 3 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
General disorders
Pyrexia
|
32.3%
10/31 • Number of events 17 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
29.4%
10/34 • Number of events 23 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
12.5%
1/8 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/31 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
5.9%
2/34 • Number of events 2 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
14.3%
1/7 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
12.5%
1/8 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Infections and infestations
Rhinitis
|
16.1%
5/31 • Number of events 9 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
17.6%
6/34 • Number of events 9 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
25.8%
8/31 • Number of events 10 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
23.5%
8/34 • Number of events 21 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
14.3%
1/7 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
62.5%
5/8 • Number of events 6 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis seasonal
|
0.00%
0/31 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
2.9%
1/34 • Number of events 2 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
12.5%
1/8 • Number of events 6 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
12.9%
4/31 • Number of events 5 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
8.8%
3/34 • Number of events 4 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
12.5%
1/8 • Number of events 4 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Immune system disorders
Seasonal allergy
|
3.2%
1/31 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
2.9%
1/34 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
14.3%
1/7 • Number of events 3 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Infections and infestations
Sinusitis
|
3.2%
1/31 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
14.7%
5/34 • Number of events 9 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
14.3%
1/7 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
12.5%
1/8 • Number of events 9 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
12.9%
4/31 • Number of events 4 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
8.8%
3/34 • Number of events 4 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Gastrointestinal disorders
Stomatitis
|
3.2%
1/31 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
8.8%
3/34 • Number of events 4 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
12.5%
1/8 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Eye disorders
Strabismus
|
3.2%
1/31 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/34 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
14.3%
1/7 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/31 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/34 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
12.5%
1/8 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar disorder
|
0.00%
0/31 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/34 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
12.5%
1/8 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
0.00%
0/31 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
2.9%
1/34 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
12.5%
1/8 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Infections and infestations
Tonsillitis
|
3.2%
1/31 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
20.6%
7/34 • Number of events 19 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
14.3%
1/7 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
25.0%
2/8 • Number of events 4 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/31 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
5.9%
2/34 • Number of events 2 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
14.3%
1/7 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
12.5%
1/8 • Number of events 2 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
71.0%
22/31 • Number of events 147 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
64.7%
22/34 • Number of events 94 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
71.4%
5/7 • Number of events 14 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
75.0%
6/8 • Number of events 32 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
12.9%
4/31 • Number of events 5 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
8.8%
3/34 • Number of events 3 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
14.3%
1/7 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Infections and infestations
Varicella
|
19.4%
6/31 • Number of events 6 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
11.8%
4/34 • Number of events 4 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
12.5%
1/8 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Gastrointestinal disorders
Vomiting
|
22.6%
7/31 • Number of events 7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
11.8%
4/34 • Number of events 6 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
25.0%
2/8 • Number of events 2 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/31 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/34 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
12.5%
1/8 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Investigations
White blood cell count increased
|
3.2%
1/31 • Number of events 3 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
5.9%
2/34 • Number of events 2 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/31 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
5.9%
2/34 • Number of events 2 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
14.3%
1/7 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/8 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
|
Skin and subcutaneous tissue disorders
Xeroderma
|
0.00%
0/31 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/34 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
0.00%
0/7 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
12.5%
1/8 • Number of events 1 • The adverse events were collected from Aug 2004 to Dec 2009.
The safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP nonconformity.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Novo Nordisk acknowledges the Investigator's right to publish the entire results of the trial. Any such scientific paper, presentation, communication or other information concerning the investigation described in this protocol, must be submitted in writing to Novo Nordisk Trial Manager prior to submission for publication/presentation for comments. Comments will be given within four weeks from receipt of the manuscript.
- Publication restrictions are in place
Restriction type: OTHER