Trial Outcomes & Findings for Treatment of Children and Adolescents With Growth Failure Associated With Primary IGF-1 Deficiency (NCT NCT00330668)
NCT ID: NCT00330668
Last Updated: 2020-08-14
Results Overview
Height was measured standing, without shoes, as the average of 3 measurements by the same observer identical technique with a Harpenden or other wall-mounted stadiometer at baseline and each study visit up to 3 years. Height velocity (during any interval of time (annualised) is computed as (height on date 2 - height on date 1)/(age on date 2 - age on date 1) where height is expressed as centimetres so that height velocity is expressed as centimetres per year (cm/yr). Height velocity is presented for subjects completing each year of BID treatment (i.e. Year 1 \[0-1 years\], Year 2 \[1-2 years\], Year 3 \[2-3 years\]).
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
114 participants
Primary outcome timeframe
At Years 1, 2 and 3 in BID dosing period.
Results posted on
2020-08-14
Participant Flow
All subjects that completed study MS301 (NCT00125164) were eligible to enter this Phase 3b, open-label, extension study in prepubertal and pubertal male and female subjects with growth failure associated with primary insulin-like growth factor-1 deficiency (IGFD). This study (MS306) was terminated early by the sponsor on 01 December 2009.
As subjects entered MS306 whilst MS301 was continuing, dosages were adjusted in MS306 after MS301 data became available. Baseline study data for MS306 were taken from the data collected for Visit 9 (Month 12) of study MS301.
Participant milestones
| Measure |
All rhIGF-1 Subjects
All subjects entering MS306 began recombinant human insulin-like growth factor-1 (rhIGF-1) twice a day (BID) treatment. Each subject treated in MS301 had an MS306 starting dose that was based on their dose at the completion of MS301 (i.e. subcutaneous injections of rhIGF-1 at 40, 80, or 120 micrograms \[μg\]/ kilogram \[kg\] BID). MS301 untreated control subjects were randomised in MS306 in a 1:1 ratio to a dose of either 80 or 120 μg/kg rhIGF-1 BID.
Following Protocol Amendment 1, the dosing regimen was changed and all subjects received either 80 or 120 μg/kg rhIGF-1 BID until the implementation of Protocol Amendment 2.
Following Protocol Amendment 2, all subjects were first switched to receive subcutaneous injections of 160 μg/kg rhIGF-1 once a day (QD), followed by individual dose-escalation first to 200 μg/kg rhIGF-1 QD and subsequently to a targeted maximum dose of 240 μg/kg rhIGF-1 QD. Subjects were treated QD until the early termination of the study.
|
|---|---|
|
BID Dosing Period
STARTED
|
114
|
|
BID Dosing Period
COMPLETED
|
78
|
|
BID Dosing Period
NOT COMPLETED
|
36
|
|
QD Dosing Period
STARTED
|
78
|
|
QD Dosing Period
COMPLETED
|
0
|
|
QD Dosing Period
NOT COMPLETED
|
78
|
Reasons for withdrawal
| Measure |
All rhIGF-1 Subjects
All subjects entering MS306 began recombinant human insulin-like growth factor-1 (rhIGF-1) twice a day (BID) treatment. Each subject treated in MS301 had an MS306 starting dose that was based on their dose at the completion of MS301 (i.e. subcutaneous injections of rhIGF-1 at 40, 80, or 120 micrograms \[μg\]/ kilogram \[kg\] BID). MS301 untreated control subjects were randomised in MS306 in a 1:1 ratio to a dose of either 80 or 120 μg/kg rhIGF-1 BID.
Following Protocol Amendment 1, the dosing regimen was changed and all subjects received either 80 or 120 μg/kg rhIGF-1 BID until the implementation of Protocol Amendment 2.
Following Protocol Amendment 2, all subjects were first switched to receive subcutaneous injections of 160 μg/kg rhIGF-1 once a day (QD), followed by individual dose-escalation first to 200 μg/kg rhIGF-1 QD and subsequently to a targeted maximum dose of 240 μg/kg rhIGF-1 QD. Subjects were treated QD until the early termination of the study.
|
|---|---|
|
BID Dosing Period
Adverse Event
|
1
|
|
BID Dosing Period
Lost to Follow-up
|
7
|
|
BID Dosing Period
Non-Compliance
|
5
|
|
BID Dosing Period
Withdrawal by Subject
|
19
|
|
BID Dosing Period
Sponsor's decision
|
1
|
|
BID Dosing Period
Other
|
3
|
|
QD Dosing Period
Sponsor decision to terminate study
|
74
|
|
QD Dosing Period
Other
|
1
|
|
QD Dosing Period
Withdrawal by Subject
|
1
|
|
QD Dosing Period
Lost to Follow-up
|
2
|
Baseline Characteristics
Treatment of Children and Adolescents With Growth Failure Associated With Primary IGF-1 Deficiency
Baseline characteristics by cohort
| Measure |
All rhIGF-1 Subjects
n=114 Participants
All subjects entering MS306 began rhIGF-1 BID treatment. Each subject treated in MS301 had an MS306 starting dose that was based on their dose at the completion of MS301 (i.e. subcutaneous injections of rhIGF-1 at 40, 80, or 120 μg/kg BID). MS301 untreated control subjects were randomised in MS306 in a 1:1 ratio to a dose of either 80 or 120 μg/kg rhIGF-1 BID.
Following Protocol Amendment 1, the dosing regimen was changed and all subjects received either 80 or 120 μg/kg rhIGF-1 BID until the implementation of Protocol Amendment 2.
Following Protocol Amendment 2, all subjects were first switched to receive subcutaneous injections of 160 μg/kg rhIGF-1 QD, followed by individual dose-escalation first to 200 μg/kg rhIGF-1 QD and subsequently to a targeted maximum dose of 240 μg/kg rhIGF-1 QD. Subjects were treated QD until the early termination of the study.
|
|---|---|
|
Age, Continuous
|
8.5 years
STANDARD_DEVIATION 2.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
82 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
100 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At Years 1, 2 and 3 in BID dosing period.Population: The modified Intent-To-Treat (MITT) population included subjects from the ITT population who were randomised to 120 μg/kg rhIGF-1 BID (either in MS301 or MS306). The subjects in the 80 μg/kg group were not analysed for efficacy due to the variations in their dose regimen and the duration of the regimen.
Height was measured standing, without shoes, as the average of 3 measurements by the same observer identical technique with a Harpenden or other wall-mounted stadiometer at baseline and each study visit up to 3 years. Height velocity (during any interval of time (annualised) is computed as (height on date 2 - height on date 1)/(age on date 2 - age on date 1) where height is expressed as centimetres so that height velocity is expressed as centimetres per year (cm/yr). Height velocity is presented for subjects completing each year of BID treatment (i.e. Year 1 \[0-1 years\], Year 2 \[1-2 years\], Year 3 \[2-3 years\]).
Outcome measures
| Measure |
120 μg/kg rhIGF-1 BID (MITT Population)
n=55 Participants
Subjects in the MITT population received 120 μg/kg rhIGF-1 BID and received the same dose throughout the BID phase of the study.
|
|---|---|
|
Height Velocity During BID Dosing Period
Year 1
|
7.7 cm/year
Standard Deviation 1.5
|
|
Height Velocity During BID Dosing Period
Year 2
|
6.1 cm/year
Standard Deviation 1.4
|
|
Height Velocity During BID Dosing Period
Year 3
|
5.9 cm/year
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: At baseline and Years 1, 2 and 3 in BID dosing period.Population: The MITT population included subjects from the ITT population who were randomised to 120 μg/kg rhIGF-1 BID (either in MS301 or MS306). The subjects in the 80 μg/kg group were not analysed for efficacy due to the variations in their dose regimen and the duration of the regimen.
Height was measured standing, without shoes, as the average of 3 measurements by the same observer using identical technique with a Harpenden or other wall-mounted stadiometer at baseline and each study visit up to 3 years. Height SD score was determined using the National Center for Health Statistics 2000 data as provided by the Center for Disease Control. The SD score was calculated as the patient value minus the mean divided by the standard deviation. The mean and the standard deviation vary depending on the age and sex of the child. Mean change from baseline in height SD score is presented for all subjects completing each year of BID treatment (i.e. Year 1 \[0-1 years\], Year 2 \[1-2 years\], Year 3 \[2-3 years\]).
Outcome measures
| Measure |
120 μg/kg rhIGF-1 BID (MITT Population)
n=55 Participants
Subjects in the MITT population received 120 μg/kg rhIGF-1 BID and received the same dose throughout the BID phase of the study.
|
|---|---|
|
Mean Change From Baseline in Height Standard Deviation (SD) Score During BID Dosing Period
Year 1
|
0.5 SD score/year
Standard Deviation 0.3
|
|
Mean Change From Baseline in Height Standard Deviation (SD) Score During BID Dosing Period
Year 2
|
0.7 SD score/year
Standard Deviation 0.4
|
|
Mean Change From Baseline in Height Standard Deviation (SD) Score During BID Dosing Period
Year 3
|
0.9 SD score/year
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: At baseline and Years 1, 2 and 3 in BID dosing period.Population: The MITT population included subjects from the ITT population who were randomised to 120 μg/kg rhIGF-1 BID (either in MS301 or MS306). The subjects in the 80 μg/kg group were not analysed for efficacy due to the variations in their dose regimen and the duration of the regimen.
BMI SD score was calculated using the National Center for Health Statistics 2000 data as provided by the Center for Disease Control. The SD score was calculated as the patient value minus the mean divided by the standard deviation. The mean and the standard deviation vary depending on the age and sex of the child. Mean change from baseline in BMI SD score is presented for all subjects completing each year of BID treatment (i.e. Year 1 \[0-1 years\], Year 2 \[1-2 years\], Year 3 \[2-3 years\]).
Outcome measures
| Measure |
120 μg/kg rhIGF-1 BID (MITT Population)
n=55 Participants
Subjects in the MITT population received 120 μg/kg rhIGF-1 BID and received the same dose throughout the BID phase of the study.
|
|---|---|
|
Mean Change From Baseline in Body Mass Index (BMI) SD Score During BID Dosing Period
Year 1
|
0.3 SD score/year
Standard Deviation 0.5
|
|
Mean Change From Baseline in Body Mass Index (BMI) SD Score During BID Dosing Period
Year 2
|
0.2 SD score/year
Standard Deviation 0.5
|
|
Mean Change From Baseline in Body Mass Index (BMI) SD Score During BID Dosing Period
Year 3
|
0.4 SD score/year
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: At baseline and Years 1, 2 and 3 in BID dosing period.Population: The MITT population included subjects from the ITT population who were randomised to 120 μg/kg rhIGF-1 BID (either in MS301 or MS306). The subjects in the 80 μg/kg group were not analysed for efficacy due to the variations in their dose regimen and the duration of the regimen.
Radiographs of the left hand and wrist were taken on an approximately annual basis for determination of bone (skeletal) age. The films were sent to a central facility for standardised evaluation. Mean change from baseline in bone age is presented for all subjects completing each year of BID treatment (i.e. Year1 \[0-1 years\], Year 2 \[1-2 years\], Year 3 \[2-3 years\]).
Outcome measures
| Measure |
120 μg/kg rhIGF-1 BID (MITT Population)
n=55 Participants
Subjects in the MITT population received 120 μg/kg rhIGF-1 BID and received the same dose throughout the BID phase of the study.
|
|---|---|
|
Mean Change From Baseline in Bone Age During BID Dosing Period
Year 1
|
1.2 Years
Standard Deviation 0.5
|
|
Mean Change From Baseline in Bone Age During BID Dosing Period
Year 2
|
2.3 Years
Standard Deviation 0.6
|
|
Mean Change From Baseline in Bone Age During BID Dosing Period
Year 3
|
3.4 Years
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: At baseline and Years 1, 2 and 3 in BID dosing period.Population: The MITT population included subjects from the ITT population who were randomised to 120 μg/kg rhIGF-1 BID (either in MS301 or MS306). The subjects in the 80 μg/kg group were not analysed for efficacy due to the variations in their dose regimen and the duration of the regimen.
Predicted adult heights were estimated using the Roche-Wainer-Theissen method which takes into account changes in age, height and bone age. Mean change from baseline in predicted adult height is presented for all subjects completing each year of BID treatment (i.e. Year 1 \[0-1 years\], Year 2 \[1-2 years\], Year 3 \[2-3 years\]).
Outcome measures
| Measure |
120 μg/kg rhIGF-1 BID (MITT Population)
n=55 Participants
Subjects in the MITT population received 120 μg/kg rhIGF-1 BID and received the same dose throughout the BID phase of the study.
|
|---|---|
|
Mean Change From Baseline in Predicted Adult Height During BID Dosing Period
Year 1
|
2.7 cm
Standard Deviation 2.0
|
|
Mean Change From Baseline in Predicted Adult Height During BID Dosing Period
Year 2
|
3.9 cm
Standard Deviation 3.2
|
|
Mean Change From Baseline in Predicted Adult Height During BID Dosing Period
Year 3
|
3.7 cm
Standard Deviation 3.4
|
Adverse Events
All rhIGF-1 Subjects
Serious events: 6 serious events
Other events: 107 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
All rhIGF-1 Subjects
n=114 participants at risk
All subjects entering MS306 began recombinant human insulin-like growth factor-1 (rhIGF-1) BID treatment. Each subject treated in MS301 had an MS306 starting dose that was based on their dose at the completion of MS301 (i.e. subcutaneous injections of rhIGF-1 at 40, 80, or 120 μg/kg BID).
MS301 untreated control subjects were randomised in MS306 in a 1:1 ratio to a dose of either 80 or 120 μg/kg rhIGF-1 BID.
Following Protocol Amendment 1, all subjects received either 80 or 120 μg/kg rhIGF-1 BID until the implementation of Protocol Amendment 2.
Following Protocol Amendment 2, all subjects were first switched to receive subcutaneous injections of 160 μg/kg rhIGF-1 QD, followed by individual dose-escalation first to 200 μg/kg rhIGF-1 QD and subsequently to a targeted maximum dose of 240 μg/kg rhIGF-1 QD. Subjects were treated QD until the early termination of the study.
|
|---|---|
|
Infections and infestations
Appendicitis
|
0.88%
1/114 • Number of events 1 • Adverse events were collected for the overall study (including both the BID and QD dosing periods) from Day 1 until early termination of the study (up to 4 years, 3 months).
The safety population included all subjects who received at least one dose of study medication.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.88%
1/114 • Number of events 1 • Adverse events were collected for the overall study (including both the BID and QD dosing periods) from Day 1 until early termination of the study (up to 4 years, 3 months).
The safety population included all subjects who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Forearm Fracture
|
0.88%
1/114 • Number of events 1 • Adverse events were collected for the overall study (including both the BID and QD dosing periods) from Day 1 until early termination of the study (up to 4 years, 3 months).
The safety population included all subjects who received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.88%
1/114 • Number of events 1 • Adverse events were collected for the overall study (including both the BID and QD dosing periods) from Day 1 until early termination of the study (up to 4 years, 3 months).
The safety population included all subjects who received at least one dose of study medication.
|
|
Infections and infestations
Otitis Externa
|
0.88%
1/114 • Number of events 1 • Adverse events were collected for the overall study (including both the BID and QD dosing periods) from Day 1 until early termination of the study (up to 4 years, 3 months).
The safety population included all subjects who received at least one dose of study medication.
|
|
Infections and infestations
Pneumonia
|
0.88%
1/114 • Number of events 1 • Adverse events were collected for the overall study (including both the BID and QD dosing periods) from Day 1 until early termination of the study (up to 4 years, 3 months).
The safety population included all subjects who received at least one dose of study medication.
|
Other adverse events
| Measure |
All rhIGF-1 Subjects
n=114 participants at risk
All subjects entering MS306 began recombinant human insulin-like growth factor-1 (rhIGF-1) BID treatment. Each subject treated in MS301 had an MS306 starting dose that was based on their dose at the completion of MS301 (i.e. subcutaneous injections of rhIGF-1 at 40, 80, or 120 μg/kg BID).
MS301 untreated control subjects were randomised in MS306 in a 1:1 ratio to a dose of either 80 or 120 μg/kg rhIGF-1 BID.
Following Protocol Amendment 1, all subjects received either 80 or 120 μg/kg rhIGF-1 BID until the implementation of Protocol Amendment 2.
Following Protocol Amendment 2, all subjects were first switched to receive subcutaneous injections of 160 μg/kg rhIGF-1 QD, followed by individual dose-escalation first to 200 μg/kg rhIGF-1 QD and subsequently to a targeted maximum dose of 240 μg/kg rhIGF-1 QD. Subjects were treated QD until the early termination of the study.
|
|---|---|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
17.5%
20/114 • Number of events 27 • Adverse events were collected for the overall study (including both the BID and QD dosing periods) from Day 1 until early termination of the study (up to 4 years, 3 months).
The safety population included all subjects who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.9%
9/114 • Number of events 15 • Adverse events were collected for the overall study (including both the BID and QD dosing periods) from Day 1 until early termination of the study (up to 4 years, 3 months).
The safety population included all subjects who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Arthropod Bite
|
6.1%
7/114 • Number of events 7 • Adverse events were collected for the overall study (including both the BID and QD dosing periods) from Day 1 until early termination of the study (up to 4 years, 3 months).
The safety population included all subjects who received at least one dose of study medication.
|
|
Investigations
Blood Glucose Decreased
|
6.1%
7/114 • Number of events 8 • Adverse events were collected for the overall study (including both the BID and QD dosing periods) from Day 1 until early termination of the study (up to 4 years, 3 months).
The safety population included all subjects who received at least one dose of study medication.
|
|
Infections and infestations
Bronchitis
|
7.0%
8/114 • Number of events 9 • Adverse events were collected for the overall study (including both the BID and QD dosing periods) from Day 1 until early termination of the study (up to 4 years, 3 months).
The safety population included all subjects who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.4%
21/114 • Number of events 27 • Adverse events were collected for the overall study (including both the BID and QD dosing periods) from Day 1 until early termination of the study (up to 4 years, 3 months).
The safety population included all subjects who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
11.4%
13/114 • Number of events 13 • Adverse events were collected for the overall study (including both the BID and QD dosing periods) from Day 1 until early termination of the study (up to 4 years, 3 months).
The safety population included all subjects who received at least one dose of study medication.
|
|
Nervous system disorders
Dizziness
|
5.3%
6/114 • Number of events 7 • Adverse events were collected for the overall study (including both the BID and QD dosing periods) from Day 1 until early termination of the study (up to 4 years, 3 months).
The safety population included all subjects who received at least one dose of study medication.
|
|
Infections and infestations
Ear Infection
|
8.8%
10/114 • Number of events 13 • Adverse events were collected for the overall study (including both the BID and QD dosing periods) from Day 1 until early termination of the study (up to 4 years, 3 months).
The safety population included all subjects who received at least one dose of study medication.
|
|
Ear and labyrinth disorders
Ear Pain
|
6.1%
7/114 • Number of events 9 • Adverse events were collected for the overall study (including both the BID and QD dosing periods) from Day 1 until early termination of the study (up to 4 years, 3 months).
The safety population included all subjects who received at least one dose of study medication.
|
|
Infections and infestations
Gastroenteritis
|
7.9%
9/114 • Number of events 14 • Adverse events were collected for the overall study (including both the BID and QD dosing periods) from Day 1 until early termination of the study (up to 4 years, 3 months).
The safety population included all subjects who received at least one dose of study medication.
|
|
Infections and infestations
Gastroenteritis Viral
|
17.5%
20/114 • Number of events 23 • Adverse events were collected for the overall study (including both the BID and QD dosing periods) from Day 1 until early termination of the study (up to 4 years, 3 months).
The safety population included all subjects who received at least one dose of study medication.
|
|
Nervous system disorders
Headache
|
30.7%
35/114 • Number of events 86 • Adverse events were collected for the overall study (including both the BID and QD dosing periods) from Day 1 until early termination of the study (up to 4 years, 3 months).
The safety population included all subjects who received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
40.4%
46/114 • Number of events 72 • Adverse events were collected for the overall study (including both the BID and QD dosing periods) from Day 1 until early termination of the study (up to 4 years, 3 months).
The safety population included all subjects who received at least one dose of study medication.
|
|
Infections and infestations
Influenza
|
19.3%
22/114 • Number of events 31 • Adverse events were collected for the overall study (including both the BID and QD dosing periods) from Day 1 until early termination of the study (up to 4 years, 3 months).
The safety population included all subjects who received at least one dose of study medication.
|
|
General disorders
Influenza Like Illness
|
7.9%
9/114 • Number of events 18 • Adverse events were collected for the overall study (including both the BID and QD dosing periods) from Day 1 until early termination of the study (up to 4 years, 3 months).
The safety population included all subjects who received at least one dose of study medication.
|
|
General disorders
Injection Site Bruising
|
7.9%
9/114 • Number of events 10 • Adverse events were collected for the overall study (including both the BID and QD dosing periods) from Day 1 until early termination of the study (up to 4 years, 3 months).
The safety population included all subjects who received at least one dose of study medication.
|
|
General disorders
Injection Site Hypertrophy
|
14.0%
16/114 • Number of events 30 • Adverse events were collected for the overall study (including both the BID and QD dosing periods) from Day 1 until early termination of the study (up to 4 years, 3 months).
The safety population included all subjects who received at least one dose of study medication.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
7.0%
8/114 • Number of events 8 • Adverse events were collected for the overall study (including both the BID and QD dosing periods) from Day 1 until early termination of the study (up to 4 years, 3 months).
The safety population included all subjects who received at least one dose of study medication.
|
|
Infections and infestations
Molluscum Contagiosum
|
6.1%
7/114 • Number of events 7 • Adverse events were collected for the overall study (including both the BID and QD dosing periods) from Day 1 until early termination of the study (up to 4 years, 3 months).
The safety population included all subjects who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
6.1%
7/114 • Number of events 13 • Adverse events were collected for the overall study (including both the BID and QD dosing periods) from Day 1 until early termination of the study (up to 4 years, 3 months).
The safety population included all subjects who received at least one dose of study medication.
|
|
Infections and infestations
Nasopharyngitis
|
19.3%
22/114 • Number of events 34 • Adverse events were collected for the overall study (including both the BID and QD dosing periods) from Day 1 until early termination of the study (up to 4 years, 3 months).
The safety population included all subjects who received at least one dose of study medication.
|
|
Infections and infestations
Otitis Externa
|
9.6%
11/114 • Number of events 16 • Adverse events were collected for the overall study (including both the BID and QD dosing periods) from Day 1 until early termination of the study (up to 4 years, 3 months).
The safety population included all subjects who received at least one dose of study medication.
|
|
Infections and infestations
Otitis Media
|
17.5%
20/114 • Number of events 28 • Adverse events were collected for the overall study (including both the BID and QD dosing periods) from Day 1 until early termination of the study (up to 4 years, 3 months).
The safety population included all subjects who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
8.8%
10/114 • Number of events 13 • Adverse events were collected for the overall study (including both the BID and QD dosing periods) from Day 1 until early termination of the study (up to 4 years, 3 months).
The safety population included all subjects who received at least one dose of study medication.
|
|
Infections and infestations
Pharyngitis Streptococcal
|
20.2%
23/114 • Number of events 32 • Adverse events were collected for the overall study (including both the BID and QD dosing periods) from Day 1 until early termination of the study (up to 4 years, 3 months).
The safety population included all subjects who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
12.3%
14/114 • Number of events 21 • Adverse events were collected for the overall study (including both the BID and QD dosing periods) from Day 1 until early termination of the study (up to 4 years, 3 months).
The safety population included all subjects who received at least one dose of study medication.
|
|
General disorders
Pyrexia
|
24.6%
28/114 • Number of events 43 • Adverse events were collected for the overall study (including both the BID and QD dosing periods) from Day 1 until early termination of the study (up to 4 years, 3 months).
The safety population included all subjects who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
5.3%
6/114 • Number of events 6 • Adverse events were collected for the overall study (including both the BID and QD dosing periods) from Day 1 until early termination of the study (up to 4 years, 3 months).
The safety population included all subjects who received at least one dose of study medication.
|
|
Immune system disorders
Seasonal Allergy
|
5.3%
6/114 • Number of events 6 • Adverse events were collected for the overall study (including both the BID and QD dosing periods) from Day 1 until early termination of the study (up to 4 years, 3 months).
The safety population included all subjects who received at least one dose of study medication.
|
|
Infections and infestations
Sinusitis
|
10.5%
12/114 • Number of events 24 • Adverse events were collected for the overall study (including both the BID and QD dosing periods) from Day 1 until early termination of the study (up to 4 years, 3 months).
The safety population included all subjects who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar Hypertrophy
|
7.0%
8/114 • Number of events 11 • Adverse events were collected for the overall study (including both the BID and QD dosing periods) from Day 1 until early termination of the study (up to 4 years, 3 months).
The safety population included all subjects who received at least one dose of study medication.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
33.3%
38/114 • Number of events 79 • Adverse events were collected for the overall study (including both the BID and QD dosing periods) from Day 1 until early termination of the study (up to 4 years, 3 months).
The safety population included all subjects who received at least one dose of study medication.
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
7.0%
8/114 • Number of events 10 • Adverse events were collected for the overall study (including both the BID and QD dosing periods) from Day 1 until early termination of the study (up to 4 years, 3 months).
The safety population included all subjects who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Vomiting
|
20.2%
23/114 • Number of events 44 • Adverse events were collected for the overall study (including both the BID and QD dosing periods) from Day 1 until early termination of the study (up to 4 years, 3 months).
The safety population included all subjects who received at least one dose of study medication.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Each investigator may publish or report data from their own subjects. The trial data in aggregate are the property of Tercica, Inc. and may not be published without permission of Tercica, Inc. Tercica, Inc. will be the final arbitrator of issues relating to the publication or presentation of the aggregate data.
- Publication restrictions are in place
Restriction type: OTHER