Trial Outcomes & Findings for STX-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF) (NCT NCT01371305)
NCT ID: NCT01371305
Last Updated: 2020-02-28
Results Overview
An AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that did not necessarily have a causal relationship with this treatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
41 participants
Primary outcome timeframe
up to Week 19
Results posted on
2020-02-28
Participant Flow
The participants were enrolled across 10 sites in the US.
Forty-one participants were randomized and received at least one dose in the study.
Participant milestones
| Measure |
BG00011 0.015 mg
Participants with idiopathic pulmonary fibrosis (IPF) received subcutaneous (SC) injection of 0.015 milligram per kilogram (mg/kg) BG00011 once weekly for 8 doses.
|
BG00011 0.1 mg
Participants with IPF received SC injection of 0.1 mg/kg BG00011 once weekly for 8 doses.
|
BG00011 0.3 mg
Participants with IPF received SC injection of 0.3 mg/kg BG00011 once weekly for 8 doses.
|
BG00011 1.0 mg
Participants with IPF received SC injection of 1.0 mg/kg BG00011 once weekly for 8 doses.
|
BG00011 3.0 mg
Participants with IPF received SC injection of 3.0 mg/kg BG00011 once weekly for 8 doses.
|
Matching Placebo
Participants with IPF received SC injection of BG00011 matching placebo once weekly for 8 doses.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
7
|
6
|
10
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
5
|
2
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
2
|
4
|
2
|
Reasons for withdrawal
| Measure |
BG00011 0.015 mg
Participants with idiopathic pulmonary fibrosis (IPF) received subcutaneous (SC) injection of 0.015 milligram per kilogram (mg/kg) BG00011 once weekly for 8 doses.
|
BG00011 0.1 mg
Participants with IPF received SC injection of 0.1 mg/kg BG00011 once weekly for 8 doses.
|
BG00011 0.3 mg
Participants with IPF received SC injection of 0.3 mg/kg BG00011 once weekly for 8 doses.
|
BG00011 1.0 mg
Participants with IPF received SC injection of 1.0 mg/kg BG00011 once weekly for 8 doses.
|
BG00011 3.0 mg
Participants with IPF received SC injection of 3.0 mg/kg BG00011 once weekly for 8 doses.
|
Matching Placebo
Participants with IPF received SC injection of BG00011 matching placebo once weekly for 8 doses.
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
2
|
1
|
0
|
|
Overall Study
Study terminated by sponsor
|
0
|
0
|
0
|
0
|
3
|
1
|
|
Overall Study
Subject request
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
STX-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Baseline characteristics by cohort
| Measure |
BG00011 0.015 mg
n=6 Participants
Participants with idiopathic pulmonary fibrosis (IPF) received subcutaneous (SC) injection of 0.015 milligram per kilogram (mg/kg) BG00011 once weekly for 8 doses.
|
BG00011 0.1 mg
n=6 Participants
Participants with IPF received SC injection of 0.1 mg/kg BG00011 once weekly for 8 doses.
|
BG00011 0.3 mg
n=6 Participants
Participants with IPF received SC injection of 0.3 mg/kg BG00011 once weekly for 8 doses.
|
BG00011 1.0 mg
n=7 Participants
Participants with IPF received SC injection of 1.0 mg/kg BG00011 once weekly for 8 doses.
|
BG00011 3.0 mg
n=6 Participants
Participants with IPF received SC injection of 3.0 mg/kg BG00011 once weekly for 8 doses.
|
Matching Placebo
n=10 Participants
Participants with IPF received SC injection of BG00011 matching placebo once weekly for 8 doses.
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
68 years
STANDARD_DEVIATION 2.7 • n=5 Participants
|
68 years
STANDARD_DEVIATION 5.9 • n=7 Participants
|
65 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
70 years
STANDARD_DEVIATION 4.0 • n=4 Participants
|
72 years
STANDARD_DEVIATION 9.7 • n=21 Participants
|
72 years
STANDARD_DEVIATION 7.4 • n=8 Participants
|
69 years
STANDARD_DEVIATION 7.1 • n=8 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
35 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
41 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
41 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: up to Week 19Population: The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo.
An AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that did not necessarily have a causal relationship with this treatment.
Outcome measures
| Measure |
BG00011 0.015 mg
n=6 Participants
Participants with idiopathic pulmonary fibrosis (IPF) received subcutaneous (SC) injection of 0.015 milligram per kilogram (mg/kg) BG00011 once weekly for 8 doses.
|
BG00011 0.1 mg
n=6 Participants
Participants with IPF received SC injection of 0.1 mg/kg BG00011 once weekly for 8 doses.
|
BG00011 0.3 mg
n=6 Participants
Participants with IPF received SC injection of 0.3 mg/kg BG00011 once weekly for 8 doses.
|
BG00011 1.0 mg
n=7 Participants
Participants with IPF received SC injection of 1.0 mg/kg BG00011 once weekly for 8 doses.
|
BG00011 3.0 mg
n=6 Participants
Participants with IPF received SC injection of 3.0 mg/kg BG00011 once weekly for 8 doses.
|
Matching Placebo
n=10 Participants
Participants with IPF received SC injection of BG00011 matching placebo once weekly for 8 doses.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs)
|
6 Participants
|
5 Participants
|
6 Participants
|
4 Participants
|
6 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50Population: Pharmacokinetic (PK) population = Safety population.
Outcome measures
| Measure |
BG00011 0.015 mg
n=6 Participants
Participants with idiopathic pulmonary fibrosis (IPF) received subcutaneous (SC) injection of 0.015 milligram per kilogram (mg/kg) BG00011 once weekly for 8 doses.
|
BG00011 0.1 mg
n=6 Participants
Participants with IPF received SC injection of 0.1 mg/kg BG00011 once weekly for 8 doses.
|
BG00011 0.3 mg
n=6 Participants
Participants with IPF received SC injection of 0.3 mg/kg BG00011 once weekly for 8 doses.
|
BG00011 1.0 mg
n=7 Participants
Participants with IPF received SC injection of 1.0 mg/kg BG00011 once weekly for 8 doses.
|
BG00011 3.0 mg
n=6 Participants
Participants with IPF received SC injection of 3.0 mg/kg BG00011 once weekly for 8 doses.
|
Matching Placebo
Participants with IPF received SC injection of BG00011 matching placebo once weekly for 8 doses.
|
|---|---|---|---|---|---|---|
|
Time to Reach Maximum Observed Serum Concentration (Tmax) of BG00011
Day 1
|
168 hours
Standard Deviation NA
Insufficient data to perform analysis.
|
101 hours
Standard Deviation 42.9
|
132 hours
Standard Deviation 39.4
|
134 hours
Standard Deviation 60.5
|
96.4 hours
Standard Deviation 53.5
|
—
|
|
Time to Reach Maximum Observed Serum Concentration (Tmax) of BG00011
Day 50
|
42.7 hours
Standard Deviation 61.9
|
64.0 hours
Standard Deviation 24.8
|
64.0 hours
Standard Deviation 51.8
|
32.0 hours
Standard Deviation 19.6
|
38.0 hours
Standard Deviation 39.4
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50Population: PK population = Safety population.
Outcome measures
| Measure |
BG00011 0.015 mg
n=6 Participants
Participants with idiopathic pulmonary fibrosis (IPF) received subcutaneous (SC) injection of 0.015 milligram per kilogram (mg/kg) BG00011 once weekly for 8 doses.
|
BG00011 0.1 mg
n=6 Participants
Participants with IPF received SC injection of 0.1 mg/kg BG00011 once weekly for 8 doses.
|
BG00011 0.3 mg
n=6 Participants
Participants with IPF received SC injection of 0.3 mg/kg BG00011 once weekly for 8 doses.
|
BG00011 1.0 mg
n=7 Participants
Participants with IPF received SC injection of 1.0 mg/kg BG00011 once weekly for 8 doses.
|
BG00011 3.0 mg
n=6 Participants
Participants with IPF received SC injection of 3.0 mg/kg BG00011 once weekly for 8 doses.
|
Matching Placebo
Participants with IPF received SC injection of BG00011 matching placebo once weekly for 8 doses.
|
|---|---|---|---|---|---|---|
|
Maximum Observed Serum Concentration (Cmax) of BG00011
Day 1
|
71.3 nanogram per milliliter (ng/mL)
Standard Deviation NA
Insufficient data to perform analysis.
|
335 nanogram per milliliter (ng/mL)
Standard Deviation 178
|
716 nanogram per milliliter (ng/mL)
Standard Deviation 281
|
4370 nanogram per milliliter (ng/mL)
Standard Deviation 1350
|
12900 nanogram per milliliter (ng/mL)
Standard Deviation 3130
|
—
|
|
Maximum Observed Serum Concentration (Cmax) of BG00011
Day 50
|
134 nanogram per milliliter (ng/mL)
Standard Deviation 44.6
|
1080 nanogram per milliliter (ng/mL)
Standard Deviation 676
|
3170 nanogram per milliliter (ng/mL)
Standard Deviation 1380
|
15400 nanogram per milliliter (ng/mL)
Standard Deviation 5180
|
52800 nanogram per milliliter (ng/mL)
Standard Deviation 17600
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50Population: PK population = Safety population.
Outcome measures
| Measure |
BG00011 0.015 mg
n=6 Participants
Participants with idiopathic pulmonary fibrosis (IPF) received subcutaneous (SC) injection of 0.015 milligram per kilogram (mg/kg) BG00011 once weekly for 8 doses.
|
BG00011 0.1 mg
n=6 Participants
Participants with IPF received SC injection of 0.1 mg/kg BG00011 once weekly for 8 doses.
|
BG00011 0.3 mg
n=6 Participants
Participants with IPF received SC injection of 0.3 mg/kg BG00011 once weekly for 8 doses.
|
BG00011 1.0 mg
n=7 Participants
Participants with IPF received SC injection of 1.0 mg/kg BG00011 once weekly for 8 doses.
|
BG00011 3.0 mg
n=6 Participants
Participants with IPF received SC injection of 3.0 mg/kg BG00011 once weekly for 8 doses.
|
Matching Placebo
Participants with IPF received SC injection of BG00011 matching placebo once weekly for 8 doses.
|
|---|---|---|---|---|---|---|
|
Area Under the Serum Concentration Time Curve From Time 0 to Last Quantifiable Observed Concentration AUC(0-t) of BG00011
Day 1
|
9200 hours nanogram per milliliter (hr*ng/mL)
Standard Deviation NA
Insufficient data to perform analysis.
|
44800 hours nanogram per milliliter (hr*ng/mL)
Standard Deviation 24800
|
92600 hours nanogram per milliliter (hr*ng/mL)
Standard Deviation 40500
|
513000 hours nanogram per milliliter (hr*ng/mL)
Standard Deviation 264000
|
1730000 hours nanogram per milliliter (hr*ng/mL)
Standard Deviation 525000
|
—
|
|
Area Under the Serum Concentration Time Curve From Time 0 to Last Quantifiable Observed Concentration AUC(0-t) of BG00011
Day 50
|
44600 hours nanogram per milliliter (hr*ng/mL)
Standard Deviation 39400
|
344000 hours nanogram per milliliter (hr*ng/mL)
Standard Deviation 169000
|
1080000 hours nanogram per milliliter (hr*ng/mL)
Standard Deviation 554000
|
6370000 hours nanogram per milliliter (hr*ng/mL)
Standard Deviation 3980000
|
25700000 hours nanogram per milliliter (hr*ng/mL)
Standard Deviation 17700000
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50Population: PK population = Safety population.
Outcome measures
| Measure |
BG00011 0.015 mg
n=6 Participants
Participants with idiopathic pulmonary fibrosis (IPF) received subcutaneous (SC) injection of 0.015 milligram per kilogram (mg/kg) BG00011 once weekly for 8 doses.
|
BG00011 0.1 mg
n=6 Participants
Participants with IPF received SC injection of 0.1 mg/kg BG00011 once weekly for 8 doses.
|
BG00011 0.3 mg
n=6 Participants
Participants with IPF received SC injection of 0.3 mg/kg BG00011 once weekly for 8 doses.
|
BG00011 1.0 mg
n=7 Participants
Participants with IPF received SC injection of 1.0 mg/kg BG00011 once weekly for 8 doses.
|
BG00011 3.0 mg
n=6 Participants
Participants with IPF received SC injection of 3.0 mg/kg BG00011 once weekly for 8 doses.
|
Matching Placebo
Participants with IPF received SC injection of BG00011 matching placebo once weekly for 8 doses.
|
|---|---|---|---|---|---|---|
|
Area Under the Serum Concentration-Time Curve From Time 0 to 168 Hours AUC(0-168) of BG00011
Day 1
|
9200 hr*ng/mL
Standard Deviation NA
Insufficient data to perform analysis.
|
44800 hr*ng/mL
Standard Deviation 24800
|
92600 hr*ng/mL
Standard Deviation 40500
|
497000 hr*ng/mL
Standard Deviation 242000
|
1690000 hr*ng/mL
Standard Deviation 438000
|
—
|
|
Area Under the Serum Concentration-Time Curve From Time 0 to 168 Hours AUC(0-168) of BG00011
Day 50
|
21000 hr*ng/mL
Standard Deviation 8250
|
159000 hr*ng/mL
Standard Deviation 91200
|
465000 hr*ng/mL
Standard Deviation 209000
|
2290000 hr*ng/mL
Standard Deviation 769000
|
8310000 hr*ng/mL
Standard Deviation 2840000
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50Population: PK population = Safety population. Data for this outcome measure was not collected at Day 1.
Outcome measures
| Measure |
BG00011 0.015 mg
n=6 Participants
Participants with idiopathic pulmonary fibrosis (IPF) received subcutaneous (SC) injection of 0.015 milligram per kilogram (mg/kg) BG00011 once weekly for 8 doses.
|
BG00011 0.1 mg
n=6 Participants
Participants with IPF received SC injection of 0.1 mg/kg BG00011 once weekly for 8 doses.
|
BG00011 0.3 mg
n=6 Participants
Participants with IPF received SC injection of 0.3 mg/kg BG00011 once weekly for 8 doses.
|
BG00011 1.0 mg
n=7 Participants
Participants with IPF received SC injection of 1.0 mg/kg BG00011 once weekly for 8 doses.
|
BG00011 3.0 mg
n=6 Participants
Participants with IPF received SC injection of 3.0 mg/kg BG00011 once weekly for 8 doses.
|
Matching Placebo
Participants with IPF received SC injection of BG00011 matching placebo once weekly for 8 doses.
|
|---|---|---|---|---|---|---|
|
Apparent Terminal Elimination Half Life (T1/2) of BG00011
Day 50
|
178 hour
Standard Deviation NA
Insufficient data to perform analysis.
|
177 hour
Standard Deviation 123
|
168 hour
Standard Deviation 56.8
|
178 hour
Standard Deviation 60.9
|
250 hour
Standard Deviation NA
Insufficient data to perform analysis.
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50Population: PK population = Safety population. Data for this outcome measure was not collected at Day 1.
Outcome measures
| Measure |
BG00011 0.015 mg
n=6 Participants
Participants with idiopathic pulmonary fibrosis (IPF) received subcutaneous (SC) injection of 0.015 milligram per kilogram (mg/kg) BG00011 once weekly for 8 doses.
|
BG00011 0.1 mg
n=6 Participants
Participants with IPF received SC injection of 0.1 mg/kg BG00011 once weekly for 8 doses.
|
BG00011 0.3 mg
n=6 Participants
Participants with IPF received SC injection of 0.3 mg/kg BG00011 once weekly for 8 doses.
|
BG00011 1.0 mg
n=7 Participants
Participants with IPF received SC injection of 1.0 mg/kg BG00011 once weekly for 8 doses.
|
BG00011 3.0 mg
n=6 Participants
Participants with IPF received SC injection of 3.0 mg/kg BG00011 once weekly for 8 doses.
|
Matching Placebo
Participants with IPF received SC injection of BG00011 matching placebo once weekly for 8 doses.
|
|---|---|---|---|---|---|---|
|
Apparent Terminal Rate Constant [λz]
Day 50
|
0.00390 hour
Standard Deviation NA
Insufficient data to perform analysis.
|
0.00508 hour
Standard Deviation 0.00226
|
0.00442 hour
Standard Deviation 0.00112
|
0.00423 hour
Standard Deviation 0.00123
|
0.00286 hour
Standard Deviation NA
Insufficient data to perform analysis.
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50Population: PK population = Safety population. Data for this outcome measure was not collected at Day 1.
Outcome measures
| Measure |
BG00011 0.015 mg
n=6 Participants
Participants with idiopathic pulmonary fibrosis (IPF) received subcutaneous (SC) injection of 0.015 milligram per kilogram (mg/kg) BG00011 once weekly for 8 doses.
|
BG00011 0.1 mg
n=6 Participants
Participants with IPF received SC injection of 0.1 mg/kg BG00011 once weekly for 8 doses.
|
BG00011 0.3 mg
n=6 Participants
Participants with IPF received SC injection of 0.3 mg/kg BG00011 once weekly for 8 doses.
|
BG00011 1.0 mg
n=7 Participants
Participants with IPF received SC injection of 1.0 mg/kg BG00011 once weekly for 8 doses.
|
BG00011 3.0 mg
n=6 Participants
Participants with IPF received SC injection of 3.0 mg/kg BG00011 once weekly for 8 doses.
|
Matching Placebo
Participants with IPF received SC injection of BG00011 matching placebo once weekly for 8 doses.
|
|---|---|---|---|---|---|---|
|
Area Under the Concentration Versus Time Curve From Time Zero to Infinity AUC(0-inf) of BG00011
Day 50
|
41900 hr*ng/mL
Standard Deviation NA
Insufficient data to perform analysis.
|
362000 hr*ng/mL
Standard Deviation 173000
|
1190000 hr*ng/mL
Standard Deviation 690000
|
7250000 hr*ng/mL
Standard Deviation 4230000
|
24300000 hr*ng/mL
Standard Deviation NA
Insufficient data to perform analysis.
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50Population: PK population = Safety population. Data for this outcome measure was not collected at Day 1.
Outcome measures
| Measure |
BG00011 0.015 mg
n=6 Participants
Participants with idiopathic pulmonary fibrosis (IPF) received subcutaneous (SC) injection of 0.015 milligram per kilogram (mg/kg) BG00011 once weekly for 8 doses.
|
BG00011 0.1 mg
n=6 Participants
Participants with IPF received SC injection of 0.1 mg/kg BG00011 once weekly for 8 doses.
|
BG00011 0.3 mg
n=6 Participants
Participants with IPF received SC injection of 0.3 mg/kg BG00011 once weekly for 8 doses.
|
BG00011 1.0 mg
n=7 Participants
Participants with IPF received SC injection of 1.0 mg/kg BG00011 once weekly for 8 doses.
|
BG00011 3.0 mg
n=6 Participants
Participants with IPF received SC injection of 3.0 mg/kg BG00011 once weekly for 8 doses.
|
Matching Placebo
Participants with IPF received SC injection of BG00011 matching placebo once weekly for 8 doses.
|
|---|---|---|---|---|---|---|
|
Apparent Clearance (CL/F) of BG00011
Day 50
|
0.913 milliliter/hour/kilogram (mL/hr/kg)
Standard Deviation NA
Insufficient data to perform analysis.
|
0.758 milliliter/hour/kilogram (mL/hr/kg)
Standard Deviation 0.290
|
0.801 milliliter/hour/kilogram (mL/hr/kg)
Standard Deviation 0.441
|
0.501 milliliter/hour/kilogram (mL/hr/kg)
Standard Deviation 0.172
|
0.486 milliliter/hour/kilogram (mL/hr/kg)
Standard Deviation NA
Insufficient data to perform analysis.
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50Population: PK population = safety population. Data for this outcome measure was not analysed on day 1.
Outcome measures
| Measure |
BG00011 0.015 mg
n=6 Participants
Participants with idiopathic pulmonary fibrosis (IPF) received subcutaneous (SC) injection of 0.015 milligram per kilogram (mg/kg) BG00011 once weekly for 8 doses.
|
BG00011 0.1 mg
n=6 Participants
Participants with IPF received SC injection of 0.1 mg/kg BG00011 once weekly for 8 doses.
|
BG00011 0.3 mg
n=6 Participants
Participants with IPF received SC injection of 0.3 mg/kg BG00011 once weekly for 8 doses.
|
BG00011 1.0 mg
n=7 Participants
Participants with IPF received SC injection of 1.0 mg/kg BG00011 once weekly for 8 doses.
|
BG00011 3.0 mg
n=6 Participants
Participants with IPF received SC injection of 3.0 mg/kg BG00011 once weekly for 8 doses.
|
Matching Placebo
Participants with IPF received SC injection of BG00011 matching placebo once weekly for 8 doses.
|
|---|---|---|---|---|---|---|
|
Apparent Volume of Distribution (Vd/F) of BG00011
Day 50
|
234 milliliter per kilogram (mL/kg)
Standard Deviation NA
Insufficient data to perform analysis.
|
183 milliliter per kilogram (mL/kg)
Standard Deviation 96.0
|
183 milliliter per kilogram (mL/kg)
Standard Deviation 88.0
|
120 milliliter per kilogram (mL/kg)
Standard Deviation 29.8
|
168 milliliter per kilogram (mL/kg)
Standard Deviation NA
Insufficient data to perform analysis.
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 8 (Follow up)Population: The "Pharmacodynamic" population consisted of all participants who received at least 1 multiple dose injection of BG00011 and have a corresponding sample collected for BAL and/or blood biomarkers.
The expression level of 7 genes; Arachidonate 5-lipoxygenase (ALOX5), fibronectin 1 (FN1), Oxidized low density lipoprotein receptor 1 (OLR1), Plasminogen activator inhibitor-1 (PAI-1; aka SERPINE 1), Transglutaminase 2 (TGM2), Triggering receptor expressed on myeloid cells 1 (TREM1), and v-ets erythroblastosis virus E26 oncogene homolog 1 (ETS1) were assessed via BAL as well as a ratio of pSMAD2 to tSMAD2 levels.
Outcome measures
| Measure |
BG00011 0.015 mg
n=6 Participants
Participants with idiopathic pulmonary fibrosis (IPF) received subcutaneous (SC) injection of 0.015 milligram per kilogram (mg/kg) BG00011 once weekly for 8 doses.
|
BG00011 0.1 mg
n=6 Participants
Participants with IPF received SC injection of 0.1 mg/kg BG00011 once weekly for 8 doses.
|
BG00011 0.3 mg
n=6 Participants
Participants with IPF received SC injection of 0.3 mg/kg BG00011 once weekly for 8 doses.
|
BG00011 1.0 mg
n=7 Participants
Participants with IPF received SC injection of 1.0 mg/kg BG00011 once weekly for 8 doses.
|
BG00011 3.0 mg
n=4 Participants
Participants with IPF received SC injection of 3.0 mg/kg BG00011 once weekly for 8 doses.
|
Matching Placebo
n=10 Participants
Participants with IPF received SC injection of BG00011 matching placebo once weekly for 8 doses.
|
|---|---|---|---|---|---|---|
|
Percentage Change (PC) From Baseline in Biomarkers Isolated From Bronchoalveolar Lavage (BAL)
ALOX5; PC at Day 8 (Follow Up)
|
4.39 Percentage
Standard Deviation 16.560
|
-0.25 Percentage
Standard Deviation 11.154
|
-5.16 Percentage
Standard Deviation 23.074
|
-51.07 Percentage
Standard Deviation 22.942
|
-70.90 Percentage
Standard Deviation 14.633
|
-7.87 Percentage
Standard Deviation 15.793
|
|
Percentage Change (PC) From Baseline in Biomarkers Isolated From Bronchoalveolar Lavage (BAL)
FN1; PC at Day 8 (Follow Up)
|
0.42 Percentage
Standard Deviation 20.776
|
-4.83 Percentage
Standard Deviation 22.035
|
-16.84 Percentage
Standard Deviation 15.424
|
-65.41 Percentage
Standard Deviation 16.174
|
-77.42 Percentage
Standard Deviation 17.989
|
-8.27 Percentage
Standard Deviation 23.881
|
|
Percentage Change (PC) From Baseline in Biomarkers Isolated From Bronchoalveolar Lavage (BAL)
OLR1; PC at Day 8 (Follow Up)
|
-4.79 Percentage
Standard Deviation 31.104
|
-1.58 Percentage
Standard Deviation 16.207
|
-15.09 Percentage
Standard Deviation 25.235
|
-63.64 Percentage
Standard Deviation 18.657
|
-77.97 Percentage
Standard Deviation 14.602
|
-3.56 Percentage
Standard Deviation 21.215
|
|
Percentage Change (PC) From Baseline in Biomarkers Isolated From Bronchoalveolar Lavage (BAL)
PAI-1; aka SERPINE 1; PC at Day 8 (Follow Up)
|
26.98 Percentage
Standard Deviation 55.559
|
-28.27 Percentage
Standard Deviation 10.055
|
7.83 Percentage
Standard Deviation 30.064
|
-26.06 Percentage
Standard Deviation 38.247
|
71.44 Percentage
Standard Deviation 115.042
|
-1.40 Percentage
Standard Deviation 59.537
|
|
Percentage Change (PC) From Baseline in Biomarkers Isolated From Bronchoalveolar Lavage (BAL)
TGM2; PC at Day 8 (Follow Up)
|
0.71 Percentage
Standard Deviation 31.009
|
-3.06 Percentage
Standard Deviation 41.757
|
-13.17 Percentage
Standard Deviation 35.547
|
-53.15 Percentage
Standard Deviation 28.412
|
-71.35 Percentage
Standard Deviation 17.449
|
15.06 Percentage
Standard Deviation 59.874
|
|
Percentage Change (PC) From Baseline in Biomarkers Isolated From Bronchoalveolar Lavage (BAL)
TREM1; PC at Day 8 (Follow Up)
|
-3.71 Percentage
Standard Deviation 20.135
|
-2.01 Percentage
Standard Deviation 16.654
|
-7.66 Percentage
Standard Deviation 21.151
|
-48.33 Percentage
Standard Deviation 23.511
|
-63.13 Percentage
Standard Deviation 13.700
|
-12.83 Percentage
Standard Deviation 17.397
|
|
Percentage Change (PC) From Baseline in Biomarkers Isolated From Bronchoalveolar Lavage (BAL)
ETS1; PC at Day 8 (Follow Up)
|
3.16 Percentage
Standard Deviation 53.425
|
-11.52 Percentage
Standard Deviation 26.342
|
-10.54 Percentage
Standard Deviation 43.866
|
240.59 Percentage
Standard Deviation 245.766
|
103.16 Percentage
Standard Deviation 152.301
|
65.10 Percentage
Standard Deviation 146.690
|
|
Percentage Change (PC) From Baseline in Biomarkers Isolated From Bronchoalveolar Lavage (BAL)
pSMAD2 to tSMAD2; PC at Day 8 (Follow Up)
|
23.91 Percentage
Standard Deviation 54.293
|
-3.33 Percentage
Standard Deviation 29.724
|
-39.82 Percentage
Standard Deviation 24.675
|
-63.74 Percentage
Standard Deviation 34.674
|
-76.20 Percentage
Standard Deviation 14.834
|
28.59 Percentage
Standard Deviation 52.270
|
SECONDARY outcome
Timeframe: Up to Week 19Population: The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo.
Outcome measures
| Measure |
BG00011 0.015 mg
n=6 Participants
Participants with idiopathic pulmonary fibrosis (IPF) received subcutaneous (SC) injection of 0.015 milligram per kilogram (mg/kg) BG00011 once weekly for 8 doses.
|
BG00011 0.1 mg
n=6 Participants
Participants with IPF received SC injection of 0.1 mg/kg BG00011 once weekly for 8 doses.
|
BG00011 0.3 mg
n=6 Participants
Participants with IPF received SC injection of 0.3 mg/kg BG00011 once weekly for 8 doses.
|
BG00011 1.0 mg
n=7 Participants
Participants with IPF received SC injection of 1.0 mg/kg BG00011 once weekly for 8 doses.
|
BG00011 3.0 mg
n=6 Participants
Participants with IPF received SC injection of 3.0 mg/kg BG00011 once weekly for 8 doses.
|
Matching Placebo
n=10 Participants
Participants with IPF received SC injection of BG00011 matching placebo once weekly for 8 doses.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Antibodies to BG00011
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
Adverse Events
BG00011 0.015 mg
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
BG00011 0.1 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
BG00011 0.3 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
BG00011 1.0 mg
Serious events: 2 serious events
Other events: 4 other events
Deaths: 1 deaths
BG00011 3.0 mg
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Matching Placebo
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BG00011 0.015 mg
n=6 participants at risk
Participants with idiopathic pulmonary fibrosis (IPF) received subcutaneous (SC) injection of 0.015 milligram per kilogram (mg/kg) BG00011 once weekly for 8 doses.
|
BG00011 0.1 mg
n=6 participants at risk
Participants with IPF received SC injection of 0.1 mg/kg BG00011 once weekly for 8 doses.
|
BG00011 0.3 mg
n=6 participants at risk
Participants with IPF received SC injection of 0.3 mg/kg BG00011 once weekly for 8 doses.
|
BG00011 1.0 mg
n=7 participants at risk
Participants with IPF received SC injection of 1.0 mg/kg BG00011 once weekly for 8 doses.
|
BG00011 3.0 mg
n=6 participants at risk
Participants with IPF received SC injection of 3.0 mg/kg BG00011 once weekly for 8 doses.
|
Matching Placebo
n=10 participants at risk
Participants with IPF received SC injection of BG00011 matching placebo once weekly for 8 doses.
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Type II Second-Degree Atrioventricular Block
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
14.3%
1/7 • Number of events 1 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Nervous system disorders
Syncope
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
14.3%
1/7 • Number of events 1 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
14.3%
1/7 • Number of events 1 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
16.7%
1/6 • Number of events 1 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Cardiac disorders
Atrioventricular Block Complete
|
16.7%
1/6 • Number of events 1 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
16.7%
1/6 • Number of events 1 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic Pulmonary Fibrosis Exacerbation
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
28.6%
2/7 • Number of events 2 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
Other adverse events
| Measure |
BG00011 0.015 mg
n=6 participants at risk
Participants with idiopathic pulmonary fibrosis (IPF) received subcutaneous (SC) injection of 0.015 milligram per kilogram (mg/kg) BG00011 once weekly for 8 doses.
|
BG00011 0.1 mg
n=6 participants at risk
Participants with IPF received SC injection of 0.1 mg/kg BG00011 once weekly for 8 doses.
|
BG00011 0.3 mg
n=6 participants at risk
Participants with IPF received SC injection of 0.3 mg/kg BG00011 once weekly for 8 doses.
|
BG00011 1.0 mg
n=7 participants at risk
Participants with IPF received SC injection of 1.0 mg/kg BG00011 once weekly for 8 doses.
|
BG00011 3.0 mg
n=6 participants at risk
Participants with IPF received SC injection of 3.0 mg/kg BG00011 once weekly for 8 doses.
|
Matching Placebo
n=10 participants at risk
Participants with IPF received SC injection of BG00011 matching placebo once weekly for 8 doses.
|
|---|---|---|---|---|---|---|
|
General disorders
Injection Site Pain
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
16.7%
1/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
16.7%
1/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
16.7%
1/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Infections and infestations
Viral Infection
|
33.3%
2/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Investigations
Hepatic Enzyme Increased
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
16.7%
1/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
16.7%
1/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
16.7%
1/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
14.3%
1/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
16.7%
1/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
10.0%
1/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic Pulmonary Fibrosis
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
28.6%
2/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
50.0%
3/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
16.7%
1/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
10.0%
1/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Vascular disorders
Phlebitis Superficial
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
10.0%
1/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
1/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
16.7%
1/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
14.3%
1/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
33.3%
2/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
10.0%
1/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
16.7%
1/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
33.3%
2/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
14.3%
1/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
16.7%
1/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
10.0%
1/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
33.3%
2/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
28.6%
2/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Respiratory, thoracic and mediastinal disorders
Viral Upper Respiratory Tract Infection
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
16.7%
1/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
28.6%
2/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
33.3%
2/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
16.7%
1/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
16.7%
1/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
33.3%
2/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
16.7%
1/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
16.7%
1/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-Airway Cough Syndrome
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
16.7%
1/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
16.7%
1/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
16.7%
1/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Respiratory, thoracic and mediastinal disorders
Increased Bronchial Secretion
|
16.7%
1/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Respiratory, thoracic and mediastinal disorders
Lung Disorder
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
14.3%
1/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Discharge Discoloration
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
16.7%
1/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
16.7%
1/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
16.7%
1/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep Apnoea Syndrome
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
14.3%
1/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum Discolored
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
16.7%
1/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
General disorders
Fatigue
|
16.7%
1/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
33.3%
2/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
10.0%
1/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
General disorders
Chest Discomfort
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
16.7%
1/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
16.7%
1/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
General disorders
Chills
|
16.7%
1/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
16.7%
1/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
General disorders
Chest Pain
|
16.7%
1/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
General disorders
Infusion Site Bruising
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
16.7%
1/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
General disorders
Injection Site Erythema
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
16.7%
1/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
General disorders
Injection Site Paraesthesia
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
14.3%
1/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
14.3%
1/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
General disorders
Oedema Peripheral
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
16.7%
1/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
General disorders
Pyrexia
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
16.7%
1/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
General disorders
Vessel Puncture Site Pain
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
16.7%
1/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
33.3%
2/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
16.7%
1/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
16.7%
1/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
10.0%
1/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
16.7%
1/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
16.7%
1/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Infections and infestations
Acute Sinusitis
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
14.3%
1/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Infections and infestations
Sinusitis
|
16.7%
1/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Infections and infestations
Genital Herpes
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
10.0%
1/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
16.7%
1/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
16.7%
1/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Nervous system disorders
Syncope
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
28.6%
2/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Nervous system disorders
Migraine
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
16.7%
1/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Investigations
Blood Lactate Dehydrogenase Increased
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
16.7%
1/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Investigations
Blood Pressure Increased
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
16.7%
1/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Investigations
Electrocardiogram Qt Prolonged
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
14.3%
1/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Investigations
Glucose Urine Present
|
16.7%
1/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Investigations
Oxygen Saturation Decreased
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
16.7%
1/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Investigations
Protein Urine Present
|
16.7%
1/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Investigations
Total Lung Capacity Decreased
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
16.7%
1/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
10.0%
1/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Investigations
Urine Analysis Abnormal
|
16.7%
1/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Investigations
Urine Leukocyte Esterase Positive
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
16.7%
1/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Investigations
Cardiac Murmur
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
10.0%
1/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Investigations
Pulmonary Function Test Decreased
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
10.0%
1/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
16.7%
1/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
14.3%
1/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
14.3%
1/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
16.7%
1/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
33.3%
2/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
16.7%
1/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
16.7%
1/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Musculoskeletal and connective tissue disorders
Muscle Fatigue
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
16.7%
1/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
14.3%
1/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Stiffness
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
16.7%
1/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
14.3%
1/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
14.3%
1/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Gastrointestinal disorders
Dyspepsia
|
16.7%
1/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
16.7%
1/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
16.7%
1/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
16.7%
1/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Gastrointestinal disorders
Sensitivity of Teeth
|
16.7%
1/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Gastrointestinal disorders
Umbilical Hernia
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
16.7%
1/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
33.3%
2/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
33.3%
2/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
16.7%
1/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
16.7%
1/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
16.7%
1/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Skin and subcutaneous tissue disorders
Skin Lesion
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
16.7%
1/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
28.6%
2/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Injury, poisoning and procedural complications
Bone Contusion
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
16.7%
1/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
14.3%
1/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Injury, poisoning and procedural complications
Jaw Fracture
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
14.3%
1/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
14.3%
1/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Injury, poisoning and procedural complications
Ligament Sprain
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
16.7%
1/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Injury, poisoning and procedural complications
Limb Injury
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
14.3%
1/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Injury, poisoning and procedural complications
Muscle Strain
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
16.7%
1/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Injury, poisoning and procedural complications
Procedural Complication
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
16.7%
1/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
16.7%
1/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
14.3%
1/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Injury, poisoning and procedural complications
Tooth Fracture
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
14.3%
1/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Injury, poisoning and procedural complications
Eye Contusion
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
10.0%
1/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Psychiatric disorders
Insomnia
|
33.3%
2/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
14.3%
1/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Psychiatric disorders
Thinking Abnormal
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
16.7%
1/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
16.7%
1/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Cardiac disorders
Atrioventricular Block Complete
|
16.7%
1/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Cardiac disorders
Atrioventricular Block Second Degree
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
14.3%
1/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Cardiac disorders
Bradycardia
|
16.7%
1/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Immune system disorders
Seasonal Allergy
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
50.0%
3/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
16.7%
1/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
16.7%
1/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
16.7%
1/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
16.7%
1/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
16.7%
1/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma of Skin
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/7 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
0.00%
0/6 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
10.0%
1/10 • Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Our agreement is subject to confidentiality but generally the PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.
- Publication restrictions are in place
Restriction type: OTHER