Trial Outcomes & Findings for Phase 2 Study of LUM-201 in Children With Growth Hormone Deficiency (OraGrowtH210 Trial) (NCT NCT04614337)
NCT ID: NCT04614337
Last Updated: 2026-06-17
Results Overview
Annualized height velocity (AHV); Height is measured in triplicate, by a calibrated stadiometer and taking the mean value AVH equation is (h2-h1/t2-t1)\*365.25; h1 = height measured at day 1 h2 = height measured at month 6 t1 = day 1 t2 = month 6
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
104 participants
Primary outcome timeframe
Day 1 to Month 6
Results posted on
2026-06-17
Participant Flow
Participant milestones
| Measure |
Predictive Enrichment Marker (PEM) Dose LUM-201 (0.8 mg/kg/Day)
LUM-201: Administered orally once
|
LUM-201 (0.8 mg/kg/Day)
LUM-201: Administered orally once daily
|
LUM-201 (1.6 mg/kg/Day)
LUM-201: Administered orally once daily
|
LUM-201 (3.2 mg/kg/Day)
LUM-201: Administered orally once daily
|
rhGH (34 µg/kg/Day)
rhGH Norditropin® pen (34 µg/kg): Administered subcutaneously (s.c., under the skin) once daily.
|
|---|---|---|---|---|---|
|
Period 1: Qualification Phase
STARTED
|
104
|
0
|
0
|
0
|
0
|
|
Period 1: Qualification Phase
COMPLETED
|
82
|
0
|
0
|
0
|
0
|
|
Period 1: Qualification Phase
NOT COMPLETED
|
22
|
0
|
0
|
0
|
0
|
|
Period 2: Randomization Phase
STARTED
|
0
|
18
|
22
|
22
|
20
|
|
Period 2: Randomization Phase
COMPLETED
|
0
|
5
|
6
|
8
|
18
|
|
Period 2: Randomization Phase
NOT COMPLETED
|
0
|
13
|
16
|
14
|
2
|
Reasons for withdrawal
| Measure |
Predictive Enrichment Marker (PEM) Dose LUM-201 (0.8 mg/kg/Day)
LUM-201: Administered orally once
|
LUM-201 (0.8 mg/kg/Day)
LUM-201: Administered orally once daily
|
LUM-201 (1.6 mg/kg/Day)
LUM-201: Administered orally once daily
|
LUM-201 (3.2 mg/kg/Day)
LUM-201: Administered orally once daily
|
rhGH (34 µg/kg/Day)
rhGH Norditropin® pen (34 µg/kg): Administered subcutaneously (s.c., under the skin) once daily.
|
|---|---|---|---|---|---|
|
Period 1: Qualification Phase
Lack of Efficacy
|
22
|
0
|
0
|
0
|
0
|
|
Period 2: Randomization Phase
Withdrawal by Subject
|
0
|
1
|
2
|
0
|
2
|
|
Period 2: Randomization Phase
Failed Annualized Height Velocity Criteria, or transitioned to Extension study early.
|
0
|
12
|
13
|
14
|
0
|
|
Period 2: Randomization Phase
Physician Decision
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Phase 2 Study of LUM-201 in Children With Growth Hormone Deficiency (OraGrowtH210 Trial)
Baseline characteristics by cohort
| Measure |
LUM-201 (0.8 mg/kg/Day)
n=18 Participants
LUM-201: Administered orally once daily
|
LUM-201 (1.6 mg/kg/Day)
n=22 Participants
LUM-201: Administered orally once daily
|
LUM-201 (3.2 mg/kg/Day)
n=22 Participants
LUM-201: Administered orally once daily
|
rhGH (34 µg/kg/Day)
n=20 Participants
rhGH Norditropin® pen (34 µg/kg): Administered subcutaneously (s.c., under the skin) once daily.
|
Total
n=82 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
18 Participants
n=9 Participants
|
22 Participants
n=27 Participants
|
22 Participants
n=267 Participants
|
20 Participants
n=265 Participants
|
82 Participants
n=568 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
|
Age, Continuous
|
101.3 months
STANDARD_DEVIATION 29.18 • n=9 Participants
|
95.2 months
STANDARD_DEVIATION 27.26 • n=27 Participants
|
94.5 months
STANDARD_DEVIATION 21.07 • n=267 Participants
|
91.4 months
STANDARD_DEVIATION 23.26 • n=265 Participants
|
95.5 months
STANDARD_DEVIATION 25.01 • n=568 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=9 Participants
|
11 Participants
n=27 Participants
|
10 Participants
n=267 Participants
|
8 Participants
n=265 Participants
|
36 Participants
n=568 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=9 Participants
|
11 Participants
n=27 Participants
|
12 Participants
n=267 Participants
|
12 Participants
n=265 Participants
|
46 Participants
n=568 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
1 Participants
n=265 Participants
|
4 Participants
n=568 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=9 Participants
|
20 Participants
n=27 Participants
|
20 Participants
n=267 Participants
|
18 Participants
n=265 Participants
|
74 Participants
n=568 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
1 Participants
n=265 Participants
|
4 Participants
n=568 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
|
Bone Age (BA)
|
6.542 years
STANDARD_DEVIATION 2.4882 • n=9 Participants
|
5.905 years
STANDARD_DEVIATION 2.3835 • n=27 Participants
|
5.715 years
STANDARD_DEVIATION 1.9553 • n=267 Participants
|
5.570 years
STANDARD_DEVIATION 1.9709 • n=265 Participants
|
5.912 years
STANDARD_DEVIATION 2.1914 • n=568 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Month 6Annualized height velocity (AHV); Height is measured in triplicate, by a calibrated stadiometer and taking the mean value AVH equation is (h2-h1/t2-t1)\*365.25; h1 = height measured at day 1 h2 = height measured at month 6 t1 = day 1 t2 = month 6
Outcome measures
| Measure |
LUM-201 (1.6 mg/kg/Day)
n=22 Participants
LUM-201: Administered orally once daily
|
LUM-201 (3.2 mg/kg/Day)
n=22 Participants
LUM-201: Administered orally once daily
|
rhGH (34 µg/kg/Day)
n=18 Participants
rhGH Norditropin® pen (34 µg/kg): Administered subcutaneously (s.c., under the skin) once daily.
|
LUM-201 (0.8 mg/kg/Day)
n=18 Participants
LUM-201: Administered orally once daily
|
|---|---|---|---|---|
|
Percentage of Participants With a Positive Growth Response From Day 1 to Month 6 (AHV >= 6.85 cm/yr)
|
72.7 percentage of participants
|
72.7 percentage of participants
|
100 percentage of participants
|
44.4 percentage of participants
|
PRIMARY outcome
Timeframe: Day 1 to Month 6Population: This is the per protocol population.
Annualized height velocity to be measured.
Outcome measures
| Measure |
LUM-201 (1.6 mg/kg/Day)
n=22 Participants
LUM-201: Administered orally once daily
|
LUM-201 (3.2 mg/kg/Day)
n=22 Participants
LUM-201: Administered orally once daily
|
rhGH (34 µg/kg/Day)
n=18 Participants
rhGH Norditropin® pen (34 µg/kg): Administered subcutaneously (s.c., under the skin) once daily.
|
LUM-201 (0.8 mg/kg/Day)
n=18 Participants
LUM-201: Administered orally once daily
|
|---|---|---|---|---|
|
AHV After 6 Months on LUM-201 Compared to rhGH
|
8.2135 centimeters per year
Standard Deviation 1.88092
|
7.7342 centimeters per year
Standard Deviation 1.79706
|
10.5739 centimeters per year
Standard Deviation 2.04380
|
6.7575 centimeters per year
Standard Deviation 1.30141
|
SECONDARY outcome
Timeframe: Screening to Day 1Population: All subject data was combined as this test was part of study eligibility. Participants analyzed does not match participants enrolled because not all 2nd PEM results were done.
PEM Test Reproducibility Safety Population
Outcome measures
| Measure |
LUM-201 (1.6 mg/kg/Day)
LUM-201: Administered orally once daily
|
LUM-201 (3.2 mg/kg/Day)
LUM-201: Administered orally once daily
|
rhGH (34 µg/kg/Day)
rhGH Norditropin® pen (34 µg/kg): Administered subcutaneously (s.c., under the skin) once daily.
|
LUM-201 (0.8 mg/kg/Day)
n=78 Participants
LUM-201: Administered orally once daily
|
|---|---|---|---|---|
|
Percentage of Participants With a Positive Result on Both PEM Tests (at Screening and on Day 1)
|
—
|
—
|
—
|
100 percentage of participants
Interval 95.4 to 100.0
|
SECONDARY outcome
Timeframe: Day 1 to Month 6Population: This is not a Z-Score analysis. Standard deviation score of 0 is the population mean for the age/sex. Normal range is typically -2 to +2 SDS. A positive score is an improvement and a negative score a decrease.
Full Analysis Set Population month 6
Outcome measures
| Measure |
LUM-201 (1.6 mg/kg/Day)
n=22 Participants
LUM-201: Administered orally once daily
|
LUM-201 (3.2 mg/kg/Day)
n=22 Participants
LUM-201: Administered orally once daily
|
rhGH (34 µg/kg/Day)
n=19 Participants
rhGH Norditropin® pen (34 µg/kg): Administered subcutaneously (s.c., under the skin) once daily.
|
LUM-201 (0.8 mg/kg/Day)
n=18 Participants
LUM-201: Administered orally once daily
|
|---|---|---|---|---|
|
Change in Height Standard Deviation Score (SDS)
|
0.238 Standard Deviation Score
Standard Deviation 0.1767
|
0.215 Standard Deviation Score
Standard Deviation 0.1716
|
0.444 Standard Deviation Score
Standard Deviation 0.1810
|
0.108 Standard Deviation Score
Standard Deviation 0.1230
|
SECONDARY outcome
Timeframe: Day 1 to Month 12Population: This is not a Z-Score analysis. Standard deviation score of 0 is the population mean for the age/sex. Normal range is typically -2 to +2 SDS. A positive score is an improvement and a negative score a decrease.
Full Analysis Set Population month 12
Outcome measures
| Measure |
LUM-201 (1.6 mg/kg/Day)
n=22 Participants
LUM-201: Administered orally once daily
|
LUM-201 (3.2 mg/kg/Day)
n=22 Participants
LUM-201: Administered orally once daily
|
rhGH (34 µg/kg/Day)
n=19 Participants
rhGH Norditropin® pen (34 µg/kg): Administered subcutaneously (s.c., under the skin) once daily.
|
LUM-201 (0.8 mg/kg/Day)
n=18 Participants
LUM-201: Administered orally once daily
|
|---|---|---|---|---|
|
Change in Height Standard Deviation Score (SDS)
|
0.370 Standard Deviation Score
Standard Deviation 0.2786
|
0.369 Standard Deviation Score
Standard Deviation 0.2514
|
0.732 Standard Deviation Score
Standard Deviation 0.2424
|
0.207 Standard Deviation Score
Standard Deviation 0.2359
|
SECONDARY outcome
Timeframe: Day 1 to Month 6Change in Weight from baseline
Outcome measures
| Measure |
LUM-201 (1.6 mg/kg/Day)
n=22 Participants
LUM-201: Administered orally once daily
|
LUM-201 (3.2 mg/kg/Day)
n=22 Participants
LUM-201: Administered orally once daily
|
rhGH (34 µg/kg/Day)
n=19 Participants
rhGH Norditropin® pen (34 µg/kg): Administered subcutaneously (s.c., under the skin) once daily.
|
LUM-201 (0.8 mg/kg/Day)
n=18 Participants
LUM-201: Administered orally once daily
|
|---|---|---|---|---|
|
Change in Weight From Baseline
|
2.680 kg
Standard Deviation 1.2710
|
2.530 kg
Standard Deviation 0.7133
|
1.737 kg
Standard Deviation 0.6940
|
2.392 kg
Standard Deviation 1.3859
|
SECONDARY outcome
Timeframe: Day 1 to Month 12Change in Weight from baseline
Outcome measures
| Measure |
LUM-201 (1.6 mg/kg/Day)
n=21 Participants
LUM-201: Administered orally once daily
|
LUM-201 (3.2 mg/kg/Day)
n=22 Participants
LUM-201: Administered orally once daily
|
rhGH (34 µg/kg/Day)
n=18 Participants
rhGH Norditropin® pen (34 µg/kg): Administered subcutaneously (s.c., under the skin) once daily.
|
LUM-201 (0.8 mg/kg/Day)
n=18 Participants
LUM-201: Administered orally once daily
|
|---|---|---|---|---|
|
Change in Weight From Baseline
|
4.198 kg
Standard Deviation 1.9390
|
4.009 kg
Standard Deviation 0.9526
|
4.031 kg
Standard Deviation 1.6109
|
4.267 kg
Standard Deviation 2.5291
|
SECONDARY outcome
Timeframe: Day 1 to Month 6Population: This is not a Z-Score analysis. Standard deviation score of 0 is the population mean for the age/sex. Normal range is typically -2 to +2 SDS. A positive score is an improvement and a negative score a decrease.
Change in Weight-SDS (Standard Deviation Score)
Outcome measures
| Measure |
LUM-201 (1.6 mg/kg/Day)
n=14 Participants
LUM-201: Administered orally once daily
|
LUM-201 (3.2 mg/kg/Day)
n=17 Participants
LUM-201: Administered orally once daily
|
rhGH (34 µg/kg/Day)
n=16 Participants
rhGH Norditropin® pen (34 µg/kg): Administered subcutaneously (s.c., under the skin) once daily.
|
LUM-201 (0.8 mg/kg/Day)
n=12 Participants
LUM-201: Administered orally once daily
|
|---|---|---|---|---|
|
Change in Weight SDS
|
0.370 Standard Deviation Score
Standard Deviation 0.2817
|
0.558 Standard Deviation Score
Standard Deviation 0.2139
|
0.171 Standard Deviation Score
Standard Deviation 0.1414
|
0.322 Standard Deviation Score
Standard Deviation 0.3149
|
SECONDARY outcome
Timeframe: Day 1 to Month 12Population: This is not a Z-Score analysis. Standard deviation score of 0 is the population mean for the age/sex. Normal range is typically -2 to +2 SDS. A positive score is an improvement and a negative score a decrease.
Change in Weight-SDS (Standard Deviation Score)
Outcome measures
| Measure |
LUM-201 (1.6 mg/kg/Day)
n=12 Participants
LUM-201: Administered orally once daily
|
LUM-201 (3.2 mg/kg/Day)
n=15 Participants
LUM-201: Administered orally once daily
|
rhGH (34 µg/kg/Day)
n=11 Participants
rhGH Norditropin® pen (34 µg/kg): Administered subcutaneously (s.c., under the skin) once daily.
|
LUM-201 (0.8 mg/kg/Day)
n=9 Participants
LUM-201: Administered orally once daily
|
|---|---|---|---|---|
|
Change in Weight SDS
|
0.446 Standard Deviation Score
Standard Deviation 0.2912
|
0.611 Standard Deviation Score
Standard Deviation 0.2695
|
0.392 Standard Deviation Score
Standard Deviation 0.3261
|
0.537 Standard Deviation Score
Standard Deviation 0.5800
|
SECONDARY outcome
Timeframe: Day 1 to Month 6Change in BMI from baseline
Outcome measures
| Measure |
LUM-201 (1.6 mg/kg/Day)
n=22 Participants
LUM-201: Administered orally once daily
|
LUM-201 (3.2 mg/kg/Day)
n=22 Participants
LUM-201: Administered orally once daily
|
rhGH (34 µg/kg/Day)
n=19 Participants
rhGH Norditropin® pen (34 µg/kg): Administered subcutaneously (s.c., under the skin) once daily.
|
LUM-201 (0.8 mg/kg/Day)
n=18 Participants
LUM-201: Administered orally once daily
|
|---|---|---|---|---|
|
Change in Body Mass Index (BMI)
|
0.80 kg/m2
Standard Deviation 0.643
|
0.87 kg/m2
Standard Deviation 0.483
|
-0.19 kg/m2
Standard Deviation 0.623
|
0.74 kg/m2
Standard Deviation 0.741
|
SECONDARY outcome
Timeframe: Day 1 to Month 12Change in BMI (Body Mass Index) from baseline
Outcome measures
| Measure |
LUM-201 (1.6 mg/kg/Day)
n=21 Participants
LUM-201: Administered orally once daily
|
LUM-201 (3.2 mg/kg/Day)
n=22 Participants
LUM-201: Administered orally once daily
|
rhGH (34 µg/kg/Day)
n=17 Participants
rhGH Norditropin® pen (34 µg/kg): Administered subcutaneously (s.c., under the skin) once daily.
|
LUM-201 (0.8 mg/kg/Day)
n=18 Participants
LUM-201: Administered orally once daily
|
|---|---|---|---|---|
|
Change in BMI
|
0.84 kg/m2
Standard Deviation 0.910
|
0.95 kg/m2
Standard Deviation 0.480
|
0.26 kg/m2
Standard Deviation 1.018
|
1.12 kg/m2
Standard Deviation 1.305
|
SECONDARY outcome
Timeframe: Day 1 to Month 6Population: This is not a Z-Score analysis. Standard deviation score of 0 is the population mean for the age/sex. Normal range is typically -2 to +2 SDS. A positive score is an improvement and a negative score a decrease.
Change in BMI SDS
Outcome measures
| Measure |
LUM-201 (1.6 mg/kg/Day)
n=22 Participants
LUM-201: Administered orally once daily
|
LUM-201 (3.2 mg/kg/Day)
n=22 Participants
LUM-201: Administered orally once daily
|
rhGH (34 µg/kg/Day)
n=19 Participants
rhGH Norditropin® pen (34 µg/kg): Administered subcutaneously (s.c., under the skin) once daily.
|
LUM-201 (0.8 mg/kg/Day)
n=18 Participants
LUM-201: Administered orally once daily
|
|---|---|---|---|---|
|
Change in BMI SDS
|
0.318 Standard Deviation Score
Standard Deviation 0.2852
|
0.460 Standard Deviation Score
Standard Deviation 0.3091
|
-0.205 Standard Deviation Score
Standard Deviation 0.3064
|
0.286 Standard Deviation Score
Standard Deviation 0.3311
|
SECONDARY outcome
Timeframe: Day 1 to Month 12Change in BMI SDS This is not a Z-Score analysis. Standard deviation score of 0 is the population mean for the age/sex. Normal range is typically -2 to +2 SDS. A positive score is an improvement and a negative score a decrease.
Outcome measures
| Measure |
LUM-201 (1.6 mg/kg/Day)
n=21 Participants
LUM-201: Administered orally once daily
|
LUM-201 (3.2 mg/kg/Day)
n=22 Participants
LUM-201: Administered orally once daily
|
rhGH (34 µg/kg/Day)
n=17 Participants
rhGH Norditropin® pen (34 µg/kg): Administered subcutaneously (s.c., under the skin) once daily.
|
LUM-201 (0.8 mg/kg/Day)
n=18 Participants
LUM-201: Administered orally once daily
|
|---|---|---|---|---|
|
Change in BMI SDS
|
0.169 Standard Deviation Score
Standard Deviation 0.4053
|
0.411 Standard Deviation Score
Standard Deviation 0.3097
|
-0.075 Standard Deviation Score
Standard Deviation 0.4969
|
0.317 Standard Deviation Score
Standard Deviation 0.5017
|
SECONDARY outcome
Timeframe: Day 1 to Month 6Change in bone age, measured by X-ray of left hand and wrist using Greulich \& Pyle atlas
Outcome measures
| Measure |
LUM-201 (1.6 mg/kg/Day)
n=22 Participants
LUM-201: Administered orally once daily
|
LUM-201 (3.2 mg/kg/Day)
n=22 Participants
LUM-201: Administered orally once daily
|
rhGH (34 µg/kg/Day)
n=19 Participants
rhGH Norditropin® pen (34 µg/kg): Administered subcutaneously (s.c., under the skin) once daily.
|
LUM-201 (0.8 mg/kg/Day)
n=18 Participants
LUM-201: Administered orally once daily
|
|---|---|---|---|---|
|
Bone Age
|
0.485 Years
Standard Deviation 0.3708
|
0.439 Years
Standard Deviation 0.2149
|
0.539 Years
Standard Deviation 0.2735
|
0.455 Years
Standard Deviation 0.2002
|
SECONDARY outcome
Timeframe: Day 1 to Month 18Population: rhGH was not included because that group ended at month 12
Change in bone age, measured by X-ray of left hand and wrist using Greulich \& Pyle atlas
Outcome measures
| Measure |
LUM-201 (1.6 mg/kg/Day)
n=12 Participants
LUM-201: Administered orally once daily
|
LUM-201 (3.2 mg/kg/Day)
n=11 Participants
LUM-201: Administered orally once daily
|
rhGH (34 µg/kg/Day)
rhGH Norditropin® pen (34 µg/kg): Administered subcutaneously (s.c., under the skin) once daily.
|
LUM-201 (0.8 mg/kg/Day)
n=6 Participants
LUM-201: Administered orally once daily
|
|---|---|---|---|---|
|
Bone Age
|
1.862 Years
Standard Deviation 0.4799
|
1.585 Years
Standard Deviation 0.4960
|
—
|
1.1515 Years
Standard Deviation 0.5647
|
SECONDARY outcome
Timeframe: Day 1 to Month 6Population: Subject numbers differ at Day 1 and month 1 due to changes in PK sample collection timing that occurred as per protocol amendments throughout the trial
Serum concentrations at 30 minutes (Cmax/Steady State)
Outcome measures
| Measure |
LUM-201 (1.6 mg/kg/Day)
n=21 Participants
LUM-201: Administered orally once daily
|
LUM-201 (3.2 mg/kg/Day)
n=21 Participants
LUM-201: Administered orally once daily
|
rhGH (34 µg/kg/Day)
rhGH Norditropin® pen (34 µg/kg): Administered subcutaneously (s.c., under the skin) once daily.
|
LUM-201 (0.8 mg/kg/Day)
n=16 Participants
LUM-201: Administered orally once daily
|
|---|---|---|---|---|
|
Pharmacokinetics of LUM-201
Day 1
|
154 Concentration (ng/mL)
Standard Deviation 37.2
|
186 Concentration (ng/mL)
Standard Deviation 163
|
—
|
55.2 Concentration (ng/mL)
Standard Deviation 20.5
|
|
Pharmacokinetics of LUM-201
Month 1
|
66.2 Concentration (ng/mL)
Standard Deviation 46.3
|
165 Concentration (ng/mL)
Standard Deviation 283
|
—
|
14.2 Concentration (ng/mL)
Standard Deviation 46.6
|
|
Pharmacokinetics of LUM-201
Month 6
|
71.6 Concentration (ng/mL)
Standard Deviation 58.6
|
152 Concentration (ng/mL)
Standard Deviation 205
|
—
|
42.2 Concentration (ng/mL)
Standard Deviation 32.4
|
SECONDARY outcome
Timeframe: Month 6Population: rhGH group was not included because samples were not collected
Serum GH concentration
Outcome measures
| Measure |
LUM-201 (1.6 mg/kg/Day)
n=20 Participants
LUM-201: Administered orally once daily
|
LUM-201 (3.2 mg/kg/Day)
n=22 Participants
LUM-201: Administered orally once daily
|
rhGH (34 µg/kg/Day)
rhGH Norditropin® pen (34 µg/kg): Administered subcutaneously (s.c., under the skin) once daily.
|
LUM-201 (0.8 mg/kg/Day)
n=16 Participants
LUM-201: Administered orally once daily
|
|---|---|---|---|---|
|
Growth Hormone (GH) Concentration on Maintenance Treatment
|
7.36 ng/ml
Standard Deviation 4.384
|
7.51 ng/ml
Standard Deviation 3.815
|
—
|
9.16 ng/ml
Standard Deviation 6.501
|
SECONDARY outcome
Timeframe: Month 12Population: rhGH group was not included because samples were not collected
Serum GH concentration
Outcome measures
| Measure |
LUM-201 (1.6 mg/kg/Day)
n=18 Participants
LUM-201: Administered orally once daily
|
LUM-201 (3.2 mg/kg/Day)
n=18 Participants
LUM-201: Administered orally once daily
|
rhGH (34 µg/kg/Day)
rhGH Norditropin® pen (34 µg/kg): Administered subcutaneously (s.c., under the skin) once daily.
|
LUM-201 (0.8 mg/kg/Day)
n=14 Participants
LUM-201: Administered orally once daily
|
|---|---|---|---|---|
|
Growth Hormone (GH) Concentration on Maintenance Treatment
|
6.45 ng/ml
Standard Deviation 5.720
|
8.53 ng/ml
Standard Deviation 6.339
|
—
|
10.84 ng/ml
Standard Deviation 10.831
|
SECONDARY outcome
Timeframe: Month 6Population: Absolute values were reported not change from baseline.
Serum concentrations of insulin-like growth factor 1 This is not a Z-Score analysis. Standard deviation score of 0 is the population mean for the age/sex. Normal range is typically -2 to +2 SDS. A positive score is an improvement and a negative score a decrease.
Outcome measures
| Measure |
LUM-201 (1.6 mg/kg/Day)
n=19 Participants
LUM-201: Administered orally once daily
|
LUM-201 (3.2 mg/kg/Day)
n=22 Participants
LUM-201: Administered orally once daily
|
rhGH (34 µg/kg/Day)
n=19 Participants
rhGH Norditropin® pen (34 µg/kg): Administered subcutaneously (s.c., under the skin) once daily.
|
LUM-201 (0.8 mg/kg/Day)
n=16 Participants
LUM-201: Administered orally once daily
|
|---|---|---|---|---|
|
Insulin-like Growth Factor 1 SDS
|
0.078 Standard Deviation Score
Standard Deviation 0.6447
|
0.116 Standard Deviation Score
Standard Deviation 0.9318
|
0.524 Standard Deviation Score
Standard Deviation 0.8233
|
-0.296 Standard Deviation Score
Standard Deviation 1.0677
|
SECONDARY outcome
Timeframe: Month 12Population: Absolute values were reported not change from baseline.
Serum concentrations of insulin-like growth factor 1 This is not a Z-Score analysis. Standard deviation score of 0 is the population mean for the age/sex. Normal range is typically -2 to +2 SDS. A positive score is an improvement and a negative score a decrease.
Outcome measures
| Measure |
LUM-201 (1.6 mg/kg/Day)
n=19 Participants
LUM-201: Administered orally once daily
|
LUM-201 (3.2 mg/kg/Day)
n=21 Participants
LUM-201: Administered orally once daily
|
rhGH (34 µg/kg/Day)
n=17 Participants
rhGH Norditropin® pen (34 µg/kg): Administered subcutaneously (s.c., under the skin) once daily.
|
LUM-201 (0.8 mg/kg/Day)
n=15 Participants
LUM-201: Administered orally once daily
|
|---|---|---|---|---|
|
Insulin-like Growth Factor 1 SDS
|
-0.212 Standard Deviation Score
Standard Deviation 0.7052
|
0.165 Standard Deviation Score
Standard Deviation 1.1261
|
1.111 Standard Deviation Score
Standard Deviation 1.1737
|
-0.231 Standard Deviation Score
Standard Deviation 1.1169
|
Adverse Events
rhGH (34 µg/kg/Day)
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
PEM Dose LUM-201 (0.8 mg/kg/Day)
Serious events: 1 serious events
Other events: 22 other events
Deaths: 0 deaths
LUM-201 (0.8 mg/kg/Day)
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
LUM-201 (1.6 mg/kg/Day)
Serious events: 1 serious events
Other events: 21 other events
Deaths: 0 deaths
LUM-201 (3.2 mg/kg/Day)
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
rhGH (34 µg/kg/Day)
n=20 participants at risk
rhGH Norditropin® pen (34 µg/kg): Administered subcutaneously (s.c., under the skin) once daily.
|
PEM Dose LUM-201 (0.8 mg/kg/Day)
n=104 participants at risk
LUM-201: Administered orally once daily
|
LUM-201 (0.8 mg/kg/Day)
n=18 participants at risk
LUM-201: Administered orally once daily
|
LUM-201 (1.6 mg/kg/Day)
n=22 participants at risk
LUM-201: Administered orally once daily
|
LUM-201 (3.2 mg/kg/Day)
n=22 participants at risk
LUM-201: Administered orally once daily
|
|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Cartilage development disorder
|
0.00%
0/20 • 2 years
|
0.00%
0/104 • 2 years
|
5.6%
1/18 • 2 years
|
0.00%
0/22 • 2 years
|
0.00%
0/22 • 2 years
|
|
Renal and urinary disorders
Glycosuria
|
5.0%
1/20 • 2 years
|
0.00%
0/104 • 2 years
|
0.00%
0/18 • 2 years
|
0.00%
0/22 • 2 years
|
0.00%
0/22 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/20 • 2 years
|
0.00%
0/104 • 2 years
|
0.00%
0/18 • 2 years
|
4.5%
1/22 • 2 years
|
0.00%
0/22 • 2 years
|
|
Metabolism and nutrition disorders
Deyhdration
|
0.00%
0/20 • 2 years
|
0.96%
1/104 • 2 years
|
0.00%
0/18 • 2 years
|
0.00%
0/22 • 2 years
|
0.00%
0/22 • 2 years
|
Other adverse events
| Measure |
rhGH (34 µg/kg/Day)
n=20 participants at risk
rhGH Norditropin® pen (34 µg/kg): Administered subcutaneously (s.c., under the skin) once daily.
|
PEM Dose LUM-201 (0.8 mg/kg/Day)
n=104 participants at risk
LUM-201: Administered orally once daily
|
LUM-201 (0.8 mg/kg/Day)
n=18 participants at risk
LUM-201: Administered orally once daily
|
LUM-201 (1.6 mg/kg/Day)
n=22 participants at risk
LUM-201: Administered orally once daily
|
LUM-201 (3.2 mg/kg/Day)
n=22 participants at risk
LUM-201: Administered orally once daily
|
|---|---|---|---|---|---|
|
Infections and infestations
Entereobiasis
|
10.0%
2/20 • 2 years
|
0.00%
0/104 • 2 years
|
5.6%
1/18 • 2 years
|
0.00%
0/22 • 2 years
|
0.00%
0/22 • 2 years
|
|
Infections and infestations
Pharyngitis
|
5.0%
1/20 • 2 years
|
0.96%
1/104 • 2 years
|
5.6%
1/18 • 2 years
|
0.00%
0/22 • 2 years
|
0.00%
0/22 • 2 years
|
|
Infections and infestations
Pneumonia
|
0.00%
0/20 • 2 years
|
0.00%
0/104 • 2 years
|
0.00%
0/18 • 2 years
|
9.1%
2/22 • 2 years
|
0.00%
0/22 • 2 years
|
|
Infections and infestations
Respiratory tract infections
|
0.00%
0/20 • 2 years
|
0.00%
0/104 • 2 years
|
0.00%
0/18 • 2 years
|
9.1%
2/22 • 2 years
|
0.00%
0/22 • 2 years
|
|
Infections and infestations
Sinusitis
|
0.00%
0/20 • 2 years
|
0.00%
0/104 • 2 years
|
11.1%
2/18 • 2 years
|
0.00%
0/22 • 2 years
|
0.00%
0/22 • 2 years
|
|
Infections and infestations
Bronchitis
|
5.0%
1/20 • 2 years
|
0.00%
0/104 • 2 years
|
5.6%
1/18 • 2 years
|
0.00%
0/22 • 2 years
|
0.00%
0/22 • 2 years
|
|
Infections and infestations
Influenza
|
5.0%
1/20 • 2 years
|
0.00%
0/104 • 2 years
|
0.00%
0/18 • 2 years
|
4.5%
1/22 • 2 years
|
0.00%
0/22 • 2 years
|
|
Infections and infestations
Laryngitis
|
5.0%
1/20 • 2 years
|
0.00%
0/104 • 2 years
|
5.6%
1/18 • 2 years
|
0.00%
0/22 • 2 years
|
0.00%
0/22 • 2 years
|
|
Infections and infestations
Tonsillitis
|
5.0%
1/20 • 2 years
|
0.00%
0/104 • 2 years
|
5.6%
1/18 • 2 years
|
0.00%
0/22 • 2 years
|
0.00%
0/22 • 2 years
|
|
Infections and infestations
Varicella
|
5.0%
1/20 • 2 years
|
0.00%
0/104 • 2 years
|
0.00%
0/18 • 2 years
|
4.5%
1/22 • 2 years
|
0.00%
0/22 • 2 years
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.00%
0/20 • 2 years
|
0.00%
0/104 • 2 years
|
5.6%
1/18 • 2 years
|
0.00%
0/22 • 2 years
|
0.00%
0/22 • 2 years
|
|
Infections and infestations
Giardiasis
|
0.00%
0/20 • 2 years
|
0.00%
0/104 • 2 years
|
5.6%
1/18 • 2 years
|
0.00%
0/22 • 2 years
|
0.00%
0/22 • 2 years
|
|
Infections and infestations
Scrotal infection
|
0.00%
0/20 • 2 years
|
0.00%
0/104 • 2 years
|
5.6%
1/18 • 2 years
|
0.00%
0/22 • 2 years
|
0.00%
0/22 • 2 years
|
|
Infections and infestations
Smallpox
|
5.0%
1/20 • 2 years
|
0.00%
0/104 • 2 years
|
0.00%
0/18 • 2 years
|
0.00%
0/22 • 2 years
|
0.00%
0/22 • 2 years
|
|
Infections and infestations
Tooth abcess
|
5.0%
1/20 • 2 years
|
0.00%
0/104 • 2 years
|
0.00%
0/18 • 2 years
|
0.00%
0/22 • 2 years
|
0.00%
0/22 • 2 years
|
|
Nervous system disorders
Dizziness
|
0.00%
0/20 • 2 years
|
0.00%
0/104 • 2 years
|
5.6%
1/18 • 2 years
|
0.00%
0/22 • 2 years
|
4.5%
1/22 • 2 years
|
|
Nervous system disorders
Headache
|
25.0%
5/20 • 2 years
|
3.8%
4/104 • 2 years
|
27.8%
5/18 • 2 years
|
36.4%
8/22 • 2 years
|
27.3%
6/22 • 2 years
|
|
Nervous system disorders
Migraine
|
0.00%
0/20 • 2 years
|
0.00%
0/104 • 2 years
|
5.6%
1/18 • 2 years
|
0.00%
0/22 • 2 years
|
0.00%
0/22 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.0%
1/20 • 2 years
|
1.9%
2/104 • 2 years
|
22.2%
4/18 • 2 years
|
13.6%
3/22 • 2 years
|
13.6%
3/22 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/20 • 2 years
|
0.96%
1/104 • 2 years
|
11.1%
2/18 • 2 years
|
9.1%
2/22 • 2 years
|
9.1%
2/22 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.0%
1/20 • 2 years
|
0.00%
0/104 • 2 years
|
11.1%
2/18 • 2 years
|
13.6%
3/22 • 2 years
|
0.00%
0/22 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.0%
1/20 • 2 years
|
0.00%
0/104 • 2 years
|
5.6%
1/18 • 2 years
|
0.00%
0/22 • 2 years
|
4.5%
1/22 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal inflammation
|
0.00%
0/20 • 2 years
|
0.00%
0/104 • 2 years
|
5.6%
1/18 • 2 years
|
0.00%
0/22 • 2 years
|
4.5%
1/22 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
5.0%
1/20 • 2 years
|
0.00%
0/104 • 2 years
|
0.00%
0/18 • 2 years
|
0.00%
0/22 • 2 years
|
4.5%
1/22 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal turbinate hypertrophy
|
0.00%
0/20 • 2 years
|
0.00%
0/104 • 2 years
|
5.6%
1/18 • 2 years
|
0.00%
0/22 • 2 years
|
0.00%
0/22 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis streptococcal
|
5.0%
1/20 • 2 years
|
0.00%
0/104 • 2 years
|
0.00%
0/18 • 2 years
|
0.00%
0/22 • 2 years
|
0.00%
0/22 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
15.0%
3/20 • 2 years
|
0.96%
1/104 • 2 years
|
16.7%
3/18 • 2 years
|
13.6%
3/22 • 2 years
|
9.1%
2/22 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.0%
1/20 • 2 years
|
0.00%
0/104 • 2 years
|
5.6%
1/18 • 2 years
|
9.1%
2/22 • 2 years
|
13.6%
3/22 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
15.0%
3/20 • 2 years
|
0.00%
0/104 • 2 years
|
0.00%
0/18 • 2 years
|
0.00%
0/22 • 2 years
|
0.00%
0/22 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.0%
1/20 • 2 years
|
0.00%
0/104 • 2 years
|
0.00%
0/18 • 2 years
|
4.5%
1/22 • 2 years
|
0.00%
0/22 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Cartilage development disorder
|
0.00%
0/20 • 2 years
|
0.00%
0/104 • 2 years
|
5.6%
1/18 • 2 years
|
0.00%
0/22 • 2 years
|
0.00%
0/22 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Growing pains
|
0.00%
0/20 • 2 years
|
0.00%
0/104 • 2 years
|
5.6%
1/18 • 2 years
|
0.00%
0/22 • 2 years
|
0.00%
0/22 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
5.0%
1/20 • 2 years
|
0.00%
0/104 • 2 years
|
0.00%
0/18 • 2 years
|
0.00%
0/22 • 2 years
|
0.00%
0/22 • 2 years
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
4/20 • 2 years
|
2.9%
3/104 • 2 years
|
0.00%
0/18 • 2 years
|
9.1%
2/22 • 2 years
|
18.2%
4/22 • 2 years
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/20 • 2 years
|
0.00%
0/104 • 2 years
|
5.6%
1/18 • 2 years
|
9.1%
2/22 • 2 years
|
9.1%
2/22 • 2 years
|
|
Gastrointestinal disorders
Abdominal pain
|
5.0%
1/20 • 2 years
|
1.9%
2/104 • 2 years
|
0.00%
0/18 • 2 years
|
4.5%
1/22 • 2 years
|
9.1%
2/22 • 2 years
|
|
Gastrointestinal disorders
Diarrhoea
|
5.0%
1/20 • 2 years
|
1.9%
2/104 • 2 years
|
0.00%
0/18 • 2 years
|
9.1%
2/22 • 2 years
|
4.5%
1/22 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/20 • 2 years
|
0.00%
0/104 • 2 years
|
5.6%
1/18 • 2 years
|
9.1%
2/22 • 2 years
|
4.5%
1/22 • 2 years
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/20 • 2 years
|
0.00%
0/104 • 2 years
|
5.6%
1/18 • 2 years
|
0.00%
0/22 • 2 years
|
0.00%
0/22 • 2 years
|
|
Gastrointestinal disorders
Pyrexia
|
0.00%
0/20 • 2 years
|
0.00%
0/104 • 2 years
|
16.7%
3/18 • 2 years
|
9.1%
2/22 • 2 years
|
22.7%
5/22 • 2 years
|
|
General disorders
Fatigue
|
0.00%
0/20 • 2 years
|
0.96%
1/104 • 2 years
|
11.1%
2/18 • 2 years
|
4.5%
1/22 • 2 years
|
0.00%
0/22 • 2 years
|
|
Gastrointestinal disorders
Pain
|
5.0%
1/20 • 2 years
|
0.00%
0/104 • 2 years
|
0.00%
0/18 • 2 years
|
0.00%
0/22 • 2 years
|
0.00%
0/22 • 2 years
|
|
Injury, poisoning and procedural complications
Contusion
|
10.0%
2/20 • 2 years
|
0.00%
0/104 • 2 years
|
0.00%
0/18 • 2 years
|
0.00%
0/22 • 2 years
|
0.00%
0/22 • 2 years
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/20 • 2 years
|
0.00%
0/104 • 2 years
|
5.6%
1/18 • 2 years
|
0.00%
0/22 • 2 years
|
0.00%
0/22 • 2 years
|
|
Injury, poisoning and procedural complications
Scrotal injury
|
0.00%
0/20 • 2 years
|
0.00%
0/104 • 2 years
|
5.6%
1/18 • 2 years
|
0.00%
0/22 • 2 years
|
0.00%
0/22 • 2 years
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
0.00%
0/20 • 2 years
|
0.00%
0/104 • 2 years
|
5.6%
1/18 • 2 years
|
0.00%
0/22 • 2 years
|
0.00%
0/22 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/20 • 2 years
|
0.00%
0/104 • 2 years
|
0.00%
0/18 • 2 years
|
9.1%
2/22 • 2 years
|
9.1%
2/22 • 2 years
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
5.0%
1/20 • 2 years
|
0.00%
0/104 • 2 years
|
0.00%
0/18 • 2 years
|
4.5%
1/22 • 2 years
|
0.00%
0/22 • 2 years
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/20 • 2 years
|
0.00%
0/104 • 2 years
|
5.6%
1/18 • 2 years
|
0.00%
0/22 • 2 years
|
0.00%
0/22 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
5.0%
1/20 • 2 years
|
0.00%
0/104 • 2 years
|
0.00%
0/18 • 2 years
|
0.00%
0/22 • 2 years
|
0.00%
0/22 • 2 years
|
|
Metabolism and nutrition disorders
Increased appetite
|
15.0%
3/20 • 2 years
|
1.9%
2/104 • 2 years
|
5.6%
1/18 • 2 years
|
4.5%
1/22 • 2 years
|
4.5%
1/22 • 2 years
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.0%
1/20 • 2 years
|
0.00%
0/104 • 2 years
|
11.1%
2/18 • 2 years
|
0.00%
0/22 • 2 years
|
0.00%
0/22 • 2 years
|
|
Psychiatric disorders
Insomnia
|
5.0%
1/20 • 2 years
|
0.00%
0/104 • 2 years
|
0.00%
0/18 • 2 years
|
4.5%
1/22 • 2 years
|
4.5%
1/22 • 2 years
|
|
Psychiatric disorders
Anxiety
|
5.0%
1/20 • 2 years
|
0.00%
0/104 • 2 years
|
0.00%
0/18 • 2 years
|
0.00%
0/22 • 2 years
|
0.00%
0/22 • 2 years
|
|
Investigations
Blood urine present
|
5.0%
1/20 • 2 years
|
0.00%
0/104 • 2 years
|
0.00%
0/18 • 2 years
|
0.00%
0/22 • 2 years
|
0.00%
0/22 • 2 years
|
|
Investigations
Transaminases increased
|
5.0%
1/20 • 2 years
|
0.00%
0/104 • 2 years
|
0.00%
0/18 • 2 years
|
0.00%
0/22 • 2 years
|
0.00%
0/22 • 2 years
|
|
Eye disorders
Asthenopia
|
0.00%
0/20 • 2 years
|
0.00%
0/104 • 2 years
|
5.6%
1/18 • 2 years
|
0.00%
0/22 • 2 years
|
0.00%
0/22 • 2 years
|
|
Eye disorders
Visual impairment
|
0.00%
0/20 • 2 years
|
0.00%
0/104 • 2 years
|
5.6%
1/18 • 2 years
|
0.00%
0/22 • 2 years
|
0.00%
0/22 • 2 years
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/20 • 2 years
|
0.00%
0/104 • 2 years
|
5.6%
1/18 • 2 years
|
4.5%
1/22 • 2 years
|
0.00%
0/22 • 2 years
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/20 • 2 years
|
0.00%
0/104 • 2 years
|
5.6%
1/18 • 2 years
|
0.00%
0/22 • 2 years
|
4.5%
1/22 • 2 years
|
|
Immune system disorders
Allergy to arthropod sting
|
5.0%
1/20 • 2 years
|
0.00%
0/104 • 2 years
|
0.00%
0/18 • 2 years
|
0.00%
0/22 • 2 years
|
0.00%
0/22 • 2 years
|
|
Renal and urinary disorders
Glycosuria
|
5.0%
1/20 • 2 years
|
0.00%
0/104 • 2 years
|
0.00%
0/18 • 2 years
|
0.00%
0/22 • 2 years
|
4.5%
1/22 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Eye naevus
|
5.0%
1/20 • 2 years
|
0.00%
0/104 • 2 years
|
0.00%
0/18 • 2 years
|
0.00%
0/22 • 2 years
|
0.00%
0/22 • 2 years
|
|
Injury, poisoning and procedural complications
Injection site bruising
|
5.0%
1/20 • 2 years
|
0.00%
0/104 • 2 years
|
0.00%
0/18 • 2 years
|
0.00%
0/22 • 2 years
|
0.00%
0/22 • 2 years
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/20 • 2 years
|
0.00%
0/104 • 2 years
|
5.6%
1/18 • 2 years
|
4.5%
1/22 • 2 years
|
4.5%
1/22 • 2 years
|
|
Infections and infestations
Rhinitis
|
0.00%
0/20 • 2 years
|
0.00%
0/104 • 2 years
|
5.6%
1/18 • 2 years
|
4.5%
1/22 • 2 years
|
4.5%
1/22 • 2 years
|
|
Infections and infestations
Ear infection
|
5.0%
1/20 • 2 years
|
0.00%
0/104 • 2 years
|
0.00%
0/18 • 2 years
|
4.5%
1/22 • 2 years
|
4.5%
1/22 • 2 years
|
|
Infections and infestations
Gastroenteritis viral
|
5.0%
1/20 • 2 years
|
0.00%
0/104 • 2 years
|
0.00%
0/18 • 2 years
|
0.00%
0/22 • 2 years
|
9.1%
2/22 • 2 years
|
|
Infections and infestations
Upper respiratory tract infection
|
25.0%
5/20 • 2 years
|
0.00%
0/104 • 2 years
|
5.6%
1/18 • 2 years
|
18.2%
4/22 • 2 years
|
31.8%
7/22 • 2 years
|
|
Infections and infestations
COVID-19
|
15.0%
3/20 • 2 years
|
0.96%
1/104 • 2 years
|
5.6%
1/18 • 2 years
|
27.3%
6/22 • 2 years
|
18.2%
4/22 • 2 years
|
|
Infections and infestations
Viral infection
|
5.0%
1/20 • 2 years
|
0.00%
0/104 • 2 years
|
5.6%
1/18 • 2 years
|
22.7%
5/22 • 2 years
|
0.00%
0/22 • 2 years
|
|
Infections and infestations
Nasopharyngitis
|
15.0%
3/20 • 2 years
|
0.00%
0/104 • 2 years
|
5.6%
1/18 • 2 years
|
4.5%
1/22 • 2 years
|
9.1%
2/22 • 2 years
|
|
Infections and infestations
Otitis media
|
0.00%
0/20 • 2 years
|
0.00%
0/104 • 2 years
|
5.6%
1/18 • 2 years
|
4.5%
1/22 • 2 years
|
9.1%
2/22 • 2 years
|
|
Infections and infestations
Pharyngitis streptococcal
|
5.0%
1/20 • 2 years
|
1.9%
2/104 • 2 years
|
11.1%
2/18 • 2 years
|
0.00%
0/22 • 2 years
|
0.00%
0/22 • 2 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60