Trial Outcomes & Findings for Study of an Investigational Drug, RO7239361 (BMS-986089), in Ambulatory Boys With DMD (NCT NCT02515669)
NCT ID: NCT02515669
Last Updated: 2020-11-04
Results Overview
Percentage of participants with fatalities, adverse event (AEs) and serious adverse events (SAEs) up to Week 24. Participants in Panel 1 received 4 mg RO7239361; participants in Panel 2 received either 12.5 mg (weight between 15 and 45 kg) or 20 mg (weight \>45 kg) RO7239361, and participants in Panel 3 and the Expansion Panel received either 35 mg (weight between 15 and 45 kg) or 50 mg (weight \>45 kg) RO7239361.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
43 participants
Primary outcome timeframe
Baseline to Week 24
Results posted on
2020-11-04
Participant Flow
Doses for this study are based upon achieving a moderate to high degree of suppression in serum free myostatin at steady-state trough across 3 dose levels. A body weight-tiered, fixed-dose strategy targeting moderate (\>50%), high (\>85%) and near complete (\>95%) suppression of serum free myostatin was used to select the three doses for the study.
Starting at Week 5, participants whose weight exceeded or dropped below the dosing weight tier to which they were assigned (by \>1kg) were assigned to the new corresponding body weight-based dose within the participants assigned panel.
Participant milestones
| Measure |
Placebo
Placebo subcutaneous injections on specified days
|
Panel 1 RO7239361
RO7239361 subcutaneous injections on specified days. The Panel 1 dose targets achievement of \> 50% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. The Panel 1 body weight tier dose is \>15kg at a dose of 4 mg (milligram) /0.8 mL (millilitre).
|
Panel 2 RO7239361
RO7239361 subcutaneous injections on specified days. The Panel 2 dose targets achievement of \> 85% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 2 body weight tier doses are =\>15kg to =\< 45kg at a dose of 12.5 mg /0.25 mL and =\>45kg at a dose of 20 mg /0.4 mL
|
Panel 3 and Expansion Panel RO7239361
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of \> 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =\>15kg to =\< 45kg at a dose of 35 mg /0.7 mL and =\>45kg at a dose of 50 mg /1.0 mL
|
|---|---|---|---|---|
|
24 Week Double-Blind Phase
STARTED
|
11
|
7
|
6
|
19
|
|
24 Week Double-Blind Phase
COMPLETED
|
11
|
7
|
6
|
19
|
|
24 Week Double-Blind Phase
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
228 Week Open-Label Phase
STARTED
|
0
|
9
|
8
|
26
|
|
228 Week Open-Label Phase
COMPLETED
|
0
|
0
|
0
|
0
|
|
228 Week Open-Label Phase
NOT COMPLETED
|
0
|
9
|
8
|
26
|
Reasons for withdrawal
| Measure |
Placebo
Placebo subcutaneous injections on specified days
|
Panel 1 RO7239361
RO7239361 subcutaneous injections on specified days. The Panel 1 dose targets achievement of \> 50% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. The Panel 1 body weight tier dose is \>15kg at a dose of 4 mg (milligram) /0.8 mL (millilitre).
|
Panel 2 RO7239361
RO7239361 subcutaneous injections on specified days. The Panel 2 dose targets achievement of \> 85% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 2 body weight tier doses are =\>15kg to =\< 45kg at a dose of 12.5 mg /0.25 mL and =\>45kg at a dose of 20 mg /0.4 mL
|
Panel 3 and Expansion Panel RO7239361
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of \> 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =\>15kg to =\< 45kg at a dose of 35 mg /0.7 mL and =\>45kg at a dose of 50 mg /1.0 mL
|
|---|---|---|---|---|
|
228 Week Open-Label Phase
Other
|
0
|
0
|
1
|
4
|
|
228 Week Open-Label Phase
Lack of Efficacy
|
0
|
0
|
1
|
0
|
|
228 Week Open-Label Phase
Subject Request to Discontinue Treatment
|
0
|
0
|
2
|
3
|
|
228 Week Open-Label Phase
Administrative Reason by Sponsor
|
0
|
7
|
2
|
17
|
|
228 Week Open-Label Phase
Missing
|
0
|
2
|
2
|
2
|
Baseline Characteristics
Study of an Investigational Drug, RO7239361 (BMS-986089), in Ambulatory Boys With DMD
Baseline characteristics by cohort
| Measure |
Placebo
n=11 Participants
Placebo subcutaneous injections on specified days
|
Panel 1 RO7239361
n=7 Participants
RO7239361 subcutaneous injections on specified days. The Panel 1 dose targets achievement of \> 50% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. The Panel 1 body weight tier dose is \>15kg at a dose of 4 mg (milligram) /0.8 mL (millilitre).
|
Panel 2 RO7239361
n=6 Participants
RO7239361 subcutaneous injections on specified days. The Panel 2 dose targets achievement of \> 85% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 2 body weight tier doses are =\>15kg to =\< 45kg at a dose of 12.5 mg /0.25 mL and =\>45kg at a dose of 20 mg /0.4 mL
|
Panel 3 and Expansion Panel RO7239361
n=19 Participants
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of \> 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =\>15kg to =\< 45kg at a dose of 35 mg /0.7 mL and =\>45kg at a dose of 50 mg /1.0 mL
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
8.8 Years
STANDARD_DEVIATION 1.33 • n=93 Participants
|
8.0 Years
STANDARD_DEVIATION 2.24 • n=4 Participants
|
8.0 Years
STANDARD_DEVIATION 1.79 • n=27 Participants
|
8.1 Years
STANDARD_DEVIATION 1.81 • n=483 Participants
|
8.2 Years
STANDARD_DEVIATION 1.74 • n=36 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
19 Participants
n=483 Participants
|
43 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
13 Participants
n=483 Participants
|
34 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
5 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
9 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
13 Participants
n=483 Participants
|
31 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 24Percentage of participants with fatalities, adverse event (AEs) and serious adverse events (SAEs) up to Week 24. Participants in Panel 1 received 4 mg RO7239361; participants in Panel 2 received either 12.5 mg (weight between 15 and 45 kg) or 20 mg (weight \>45 kg) RO7239361, and participants in Panel 3 and the Expansion Panel received either 35 mg (weight between 15 and 45 kg) or 50 mg (weight \>45 kg) RO7239361.
Outcome measures
| Measure |
Placebo
n=11 Participants
Placebo subcutaneous injections on specified days
|
Panel 1 RO7239361
n=7 Participants
RO7239361 subcutaneous injections on specified days. The Panel 1 dose targets achievement of \> 50% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. The Panel 1 body weight tier dose is \>15kg at a dose of 4 mg (milligram) /0.8 mL (millilitre).
|
Panel 2 RO7239361
n=6 Participants
RO7239361 subcutaneous injections on specified days. The Panel 2 dose targets achievement of \> 85% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 2 body weight tier doses are =\>15kg to =\< 45kg at a dose of 12.5 mg /0.25 mL and =\>45kg at a dose of 20 mg /0.4 mL
|
Panel 3 and Expansion RO7239361
n=19 Participants
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of \> 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =\>15kg to =\< 45kg at a dose of 35 mg /0.7 mL and =\>45kg at a dose of 50 mg /1.0 mL
|
Expansion Panel RO7239361 35mg
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of \> 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =\>15kg to =\< 45kg at a dose of 35 mg /0.7 mL and =\>45kg at a dose of 50 mg /1.0 mL
|
Expansion Panel RO7239361 50mg
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of \> 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =\>15kg to =\< 45kg at a dose of 35 mg /0.7 mL and =\>45kg at a dose of 50 mg /1.0 mL
|
|---|---|---|---|---|---|---|
|
Safety Summary for the 24 Week Double-Blind Phase
Adverse Events (AEs)
|
81.8 percentage of participants
|
71.4 percentage of participants
|
100.0 percentage of participants
|
94.7 percentage of participants
|
—
|
—
|
|
Safety Summary for the 24 Week Double-Blind Phase
Related AEs
|
27.3 percentage of participants
|
14.3 percentage of participants
|
50.0 percentage of participants
|
36.8 percentage of participants
|
—
|
—
|
|
Safety Summary for the 24 Week Double-Blind Phase
Death
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Safety Summary for the 24 Week Double-Blind Phase
AEs leading to study withdrawal
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Safety Summary for the 24 Week Double-Blind Phase
Serious Adverse Events (SAE)
|
9.1 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
5.3 percentage of participants
|
—
|
—
|
|
Safety Summary for the 24 Week Double-Blind Phase
Very Severe AEs
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Safety Summary for the 24 Week Double-Blind Phase
Severe AEs
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline to Week 72Percentage of participants with fatalities, adverse event (AEs) and serious adverse events (SAEs) up to Week 72. Participants in Panel 1 received 4 mg RO7239361; participants in Panel 2 received either 12.5 mg (weight between 15 and 45 kg) or 20 mg (weight \>45 kg) RO7239361, and participants in Panel 3 and the Expansion Panel received either 35 mg (weight between 15 and 45 kg) or 50 mg (weight \>45 kg) RO7239361.
Outcome measures
| Measure |
Placebo
n=9 Participants
Placebo subcutaneous injections on specified days
|
Panel 1 RO7239361
n=8 Participants
RO7239361 subcutaneous injections on specified days. The Panel 1 dose targets achievement of \> 50% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. The Panel 1 body weight tier dose is \>15kg at a dose of 4 mg (milligram) /0.8 mL (millilitre).
|
Panel 2 RO7239361
n=26 Participants
RO7239361 subcutaneous injections on specified days. The Panel 2 dose targets achievement of \> 85% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 2 body weight tier doses are =\>15kg to =\< 45kg at a dose of 12.5 mg /0.25 mL and =\>45kg at a dose of 20 mg /0.4 mL
|
Panel 3 and Expansion RO7239361
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of \> 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =\>15kg to =\< 45kg at a dose of 35 mg /0.7 mL and =\>45kg at a dose of 50 mg /1.0 mL
|
Expansion Panel RO7239361 35mg
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of \> 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =\>15kg to =\< 45kg at a dose of 35 mg /0.7 mL and =\>45kg at a dose of 50 mg /1.0 mL
|
Expansion Panel RO7239361 50mg
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of \> 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =\>15kg to =\< 45kg at a dose of 35 mg /0.7 mL and =\>45kg at a dose of 50 mg /1.0 mL
|
|---|---|---|---|---|---|---|
|
Safety Summary up to Week 72
Death
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Safety Summary up to Week 72
Adverse Events (AEs)
|
100.0 percentage of participants
|
100.0 percentage of participants
|
96.2 percentage of participants
|
—
|
—
|
—
|
|
Safety Summary up to Week 72
AEs leading to study withdrawal
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Safety Summary up to Week 72
Serious Adverse Events (SAE)
|
0 percentage of participants
|
25.0 percentage of participants
|
7.7 percentage of participants
|
—
|
—
|
—
|
|
Safety Summary up to Week 72
Very Severe AEs
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Safety Summary up to Week 72
Severe AEs
|
0 percentage of participants
|
25.0 percentage of participants
|
3.8 percentage of participants
|
—
|
—
|
—
|
|
Safety Summary up to Week 72
Related AEs
|
77.8 percentage of participants
|
62.5 percentage of participants
|
50.0 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: predose, 3, 6, 72 and 96 hours (h) postdose; Days 8, 15 and 22: predose; Day 29: predose and 96 h postdose; Weeks 12 and 24: predosePK parameter estimates at steady state. Steady state was achieved following approximately 12 weeks QW administration. Panel: 1 = 4mg QW, 2 = 12.5mg QW, 3 = 35mg QW Participants in Panel 1 received 4 mg RO7239361; participants in Panel 2 received either 12.5 mg (weight between 15 and 45 kg) or 20 mg (weight \>45 kg) RO7239361, and participants in Panel 3 and the Expansion Panel received either 35 mg (weight between 15 and 45 kg) or 50 mg (weight \>45 kg) RO7239361. No participants received the Panel 2 20mg dose.
Outcome measures
| Measure |
Placebo
n=7 Participants
Placebo subcutaneous injections on specified days
|
Panel 1 RO7239361
n=6 Participants
RO7239361 subcutaneous injections on specified days. The Panel 1 dose targets achievement of \> 50% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. The Panel 1 body weight tier dose is \>15kg at a dose of 4 mg (milligram) /0.8 mL (millilitre).
|
Panel 2 RO7239361
n=19 Participants
RO7239361 subcutaneous injections on specified days. The Panel 2 dose targets achievement of \> 85% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 2 body weight tier doses are =\>15kg to =\< 45kg at a dose of 12.5 mg /0.25 mL and =\>45kg at a dose of 20 mg /0.4 mL
|
Panel 3 and Expansion RO7239361
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of \> 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =\>15kg to =\< 45kg at a dose of 35 mg /0.7 mL and =\>45kg at a dose of 50 mg /1.0 mL
|
Expansion Panel RO7239361 35mg
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of \> 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =\>15kg to =\< 45kg at a dose of 35 mg /0.7 mL and =\>45kg at a dose of 50 mg /1.0 mL
|
Expansion Panel RO7239361 50mg
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of \> 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =\>15kg to =\< 45kg at a dose of 35 mg /0.7 mL and =\>45kg at a dose of 50 mg /1.0 mL
|
|---|---|---|---|---|---|---|
|
Maximum Observed Serum Concentrations (Cmax) of RO7239361 at Steady State for 4 mg QW, 12.5 mg QW and 35 mg QW Doses.
|
3217 ng/ml
Geometric Coefficient of Variation 15.8
|
8490 ng/ml
Geometric Coefficient of Variation 21.5
|
24242 ng/ml
Geometric Coefficient of Variation 26.3
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: predose, 3, 6, 72 and 96 h postdose; Days 8, 15 and 22: predose; Day 29: predose and 96 h postdose; Weeks 12 and 24: predosePK parameter estimates at steady state following approximately 12 weeks QW administration. Panel 3 = 50 mg QW Participants in Panel 1 received 4 mg RO7239361; participants in Panel 2 received either 12.5 mg (weight between 15 and 45 kg) or 20 mg (weight \>45 kg) RO7239361, and participants in Panel 3 and the Expansion Panel received either 35 mg (weight between 15 and 45 kg) or 50 mg (weight \>45 kg) RO7239361.
Outcome measures
| Measure |
Placebo
n=19 Participants
Placebo subcutaneous injections on specified days
|
Panel 1 RO7239361
RO7239361 subcutaneous injections on specified days. The Panel 1 dose targets achievement of \> 50% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. The Panel 1 body weight tier dose is \>15kg at a dose of 4 mg (milligram) /0.8 mL (millilitre).
|
Panel 2 RO7239361
RO7239361 subcutaneous injections on specified days. The Panel 2 dose targets achievement of \> 85% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 2 body weight tier doses are =\>15kg to =\< 45kg at a dose of 12.5 mg /0.25 mL and =\>45kg at a dose of 20 mg /0.4 mL
|
Panel 3 and Expansion RO7239361
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of \> 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =\>15kg to =\< 45kg at a dose of 35 mg /0.7 mL and =\>45kg at a dose of 50 mg /1.0 mL
|
Expansion Panel RO7239361 35mg
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of \> 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =\>15kg to =\< 45kg at a dose of 35 mg /0.7 mL and =\>45kg at a dose of 50 mg /1.0 mL
|
Expansion Panel RO7239361 50mg
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of \> 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =\>15kg to =\< 45kg at a dose of 35 mg /0.7 mL and =\>45kg at a dose of 50 mg /1.0 mL
|
|---|---|---|---|---|---|---|
|
Maximum Observed Serum Concentrations (Cmax) of RO7239361 at Steady State for 50 mg QW Dose.
|
23297 ng/mL
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation not evaluable as only one participant was included at this dose.
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: predose, 3, 6, 72 and 96 h postdose; Days 8, 15 and 22: predose; Day 29: predose and 96 h postdose; Weeks 12 and 24: predosePK parameter estimates at steady state. Steady state was achieved following approximately 12 weeks QW administration. Panel: 1 = 4mg QW, 2 = 12.5mg QW, 3 = 35mg QW. Results for the Panel 3 50mg QW dose level are represented in Outcome Measure 6. Participants in Panel 1 received 4 mg RO7239361; participants in Panel 2 received either 12.5 mg (weight between 15 and 45 kg) or 20 mg (weight \>45 kg) RO7239361, and participants in Panel 3 and the Expansion Panel received either 35 mg (weight between 15 and 45 kg) or 50 mg (weight \>45 kg) RO7239361.
Outcome measures
| Measure |
Placebo
n=7 Participants
Placebo subcutaneous injections on specified days
|
Panel 1 RO7239361
n=6 Participants
RO7239361 subcutaneous injections on specified days. The Panel 1 dose targets achievement of \> 50% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. The Panel 1 body weight tier dose is \>15kg at a dose of 4 mg (milligram) /0.8 mL (millilitre).
|
Panel 2 RO7239361
n=18 Participants
RO7239361 subcutaneous injections on specified days. The Panel 2 dose targets achievement of \> 85% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 2 body weight tier doses are =\>15kg to =\< 45kg at a dose of 12.5 mg /0.25 mL and =\>45kg at a dose of 20 mg /0.4 mL
|
Panel 3 and Expansion RO7239361
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of \> 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =\>15kg to =\< 45kg at a dose of 35 mg /0.7 mL and =\>45kg at a dose of 50 mg /1.0 mL
|
Expansion Panel RO7239361 35mg
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of \> 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =\>15kg to =\< 45kg at a dose of 35 mg /0.7 mL and =\>45kg at a dose of 50 mg /1.0 mL
|
Expansion Panel RO7239361 50mg
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of \> 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =\>15kg to =\< 45kg at a dose of 35 mg /0.7 mL and =\>45kg at a dose of 50 mg /1.0 mL
|
|---|---|---|---|---|---|---|
|
Time of Maximum Observed Serum Concentrations (Tmax) of RO7239361 at Steady State for 4 mg QW, 12.5 mg QW and 35 mg QW Doses.
|
28 hour
Interval 12.0 to 48.0
|
24 hour
Interval 11.0 to 47.0
|
30 hour
Interval 11.0 to 65.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: predose, 3, 6, 72 and 96 h postdose; Days 8, 15 and 22: predose; Day 29: predose and 96 h postdose; Weeks 12 and 24: predosePK parameter estimates at steady state following approximately 12 weeks QW administration. Panel 3 = 50 mg QW Participants in Panel 1 received 4 mg RO7239361; participants in Panel 2 received either 12.5 mg (weight between 15 and 45 kg) or 20 mg (weight \>45 kg) RO7239361, and participants in Panel 3 and the Expansion Panel received either 35 mg (weight between 15 and 45 kg) or 50 mg (weight \>45 kg) RO7239361.
Outcome measures
| Measure |
Placebo
n=1 Participants
Placebo subcutaneous injections on specified days
|
Panel 1 RO7239361
RO7239361 subcutaneous injections on specified days. The Panel 1 dose targets achievement of \> 50% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. The Panel 1 body weight tier dose is \>15kg at a dose of 4 mg (milligram) /0.8 mL (millilitre).
|
Panel 2 RO7239361
RO7239361 subcutaneous injections on specified days. The Panel 2 dose targets achievement of \> 85% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 2 body weight tier doses are =\>15kg to =\< 45kg at a dose of 12.5 mg /0.25 mL and =\>45kg at a dose of 20 mg /0.4 mL
|
Panel 3 and Expansion RO7239361
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of \> 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =\>15kg to =\< 45kg at a dose of 35 mg /0.7 mL and =\>45kg at a dose of 50 mg /1.0 mL
|
Expansion Panel RO7239361 35mg
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of \> 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =\>15kg to =\< 45kg at a dose of 35 mg /0.7 mL and =\>45kg at a dose of 50 mg /1.0 mL
|
Expansion Panel RO7239361 50mg
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of \> 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =\>15kg to =\< 45kg at a dose of 35 mg /0.7 mL and =\>45kg at a dose of 50 mg /1.0 mL
|
|---|---|---|---|---|---|---|
|
Time of Maximum Observed Serum Concentrations (Tmax) of RO7239361 at Steady State for 50 mg QW Dose.
|
44 hour
Geometric Coefficient of Variation not evaluable as only one participant was included at this dose.
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: predose, 3, 6, 72 and 96 h postdose; Days 8, 15 and 22: predose; Day 29: predose and 96 h postdose; Weeks 12 and 24: predosePK parameter estimates at steady state. Steady state was achieved following approximately 12 weeks QW administration. Panel: 1 = 4mg QW, 2 = 12.5mg QW, 3 = 35mg QW Results for the Panel 3 50mg QW dose level are represented in Outcome Measure 8. Participants in Panel 1 received 4 mg RO7239361; participants in Panel 2 received either 12.5 mg (weight between 15 and 45 kg) or 20 mg (weight \>45 kg) RO7239361, and participants in Panel 3 and the Expansion Panel received either 35 mg (weight between 15 and 45 kg) or 50 mg (weight \>45 kg) RO7239361.
Outcome measures
| Measure |
Placebo
n=7 Participants
Placebo subcutaneous injections on specified days
|
Panel 1 RO7239361
n=6 Participants
RO7239361 subcutaneous injections on specified days. The Panel 1 dose targets achievement of \> 50% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. The Panel 1 body weight tier dose is \>15kg at a dose of 4 mg (milligram) /0.8 mL (millilitre).
|
Panel 2 RO7239361
n=18 Participants
RO7239361 subcutaneous injections on specified days. The Panel 2 dose targets achievement of \> 85% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 2 body weight tier doses are =\>15kg to =\< 45kg at a dose of 12.5 mg /0.25 mL and =\>45kg at a dose of 20 mg /0.4 mL
|
Panel 3 and Expansion RO7239361
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of \> 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =\>15kg to =\< 45kg at a dose of 35 mg /0.7 mL and =\>45kg at a dose of 50 mg /1.0 mL
|
Expansion Panel RO7239361 35mg
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of \> 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =\>15kg to =\< 45kg at a dose of 35 mg /0.7 mL and =\>45kg at a dose of 50 mg /1.0 mL
|
Expansion Panel RO7239361 50mg
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of \> 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =\>15kg to =\< 45kg at a dose of 35 mg /0.7 mL and =\>45kg at a dose of 50 mg /1.0 mL
|
|---|---|---|---|---|---|---|
|
Area Under the Concentration-Time Curve From Time Zero to Time of Next Dosing (AUCtau) of RO7239361 at Steady State for 4 mg QW, 12.5 mg QW and 35 mg QW Doses.
|
18676 ng•day/mL
Geometric Coefficient of Variation 23
|
51461 ng•day/mL
Geometric Coefficient of Variation 18
|
150609 ng•day/mL
Geometric Coefficient of Variation 24
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: predose, 3, 6, 72 and 96 h postdose; Days 8, 15 and 22: predose; Day 29: predose and 96 h postdose; Weeks 12 and 24: predosePK parameter estimates at steady state following approximately 12 weeks QW administration. Panel 3 = 50 mg QW Participants in Panel 1 received 4 mg RO7239361; participants in Panel 2 received either 12.5 mg (weight between 15 and 45 kg) or 20 mg (weight \>45 kg) RO7239361, and participants in Panel 3 and the Expansion Panel received either 35 mg (weight between 15 and 45 kg) or 50 mg (weight \>45 kg) RO7239361.
Outcome measures
| Measure |
Placebo
n=1 Participants
Placebo subcutaneous injections on specified days
|
Panel 1 RO7239361
RO7239361 subcutaneous injections on specified days. The Panel 1 dose targets achievement of \> 50% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. The Panel 1 body weight tier dose is \>15kg at a dose of 4 mg (milligram) /0.8 mL (millilitre).
|
Panel 2 RO7239361
RO7239361 subcutaneous injections on specified days. The Panel 2 dose targets achievement of \> 85% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 2 body weight tier doses are =\>15kg to =\< 45kg at a dose of 12.5 mg /0.25 mL and =\>45kg at a dose of 20 mg /0.4 mL
|
Panel 3 and Expansion RO7239361
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of \> 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =\>15kg to =\< 45kg at a dose of 35 mg /0.7 mL and =\>45kg at a dose of 50 mg /1.0 mL
|
Expansion Panel RO7239361 35mg
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of \> 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =\>15kg to =\< 45kg at a dose of 35 mg /0.7 mL and =\>45kg at a dose of 50 mg /1.0 mL
|
Expansion Panel RO7239361 50mg
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of \> 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =\>15kg to =\< 45kg at a dose of 35 mg /0.7 mL and =\>45kg at a dose of 50 mg /1.0 mL
|
|---|---|---|---|---|---|---|
|
Area Under the Concentration-Time Curve From Time Zero to Time of Next Dosing (AUCtau) of RO7239361 at Steady State for 50 mg QW Dose.
|
151000 ng•day/mL
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation not evaluable as only one participant was included at this dose.
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: predose, 3, 6, 72 and 96 h postdose; Days 8, 15 and 22: predose; Day 29: predose and 96 h postdose; Weeks 12 and 24: predosePopulation: Pharmacokinetic population. Panel 2, 20mg dose: the number of participants analyzed is 0 in those instances that the treatment was not administered at that visit.
Trough concentrations of RO7239361 at different dose levels. Panel 1 = 4mg, Panel 2 = 12.5mg and 20mg, Panel 3 = 35mg, Expansion Panels = 35mg and 50mg. Participants in Panel 1 received 4 mg RO7239361; participants in Panel 2 received either 12.5 mg (weight between 15 and 45 kg) or 20 mg (weight \>45 kg) RO7239361, and participants in Panel 3 and the Expansion Panel received either 35 mg (weight between 15 and 45 kg) or 50 mg (weight \>45 kg) RO7239361.
Outcome measures
| Measure |
Placebo
n=9 Participants
Placebo subcutaneous injections on specified days
|
Panel 1 RO7239361
n=7 Participants
RO7239361 subcutaneous injections on specified days. The Panel 1 dose targets achievement of \> 50% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. The Panel 1 body weight tier dose is \>15kg at a dose of 4 mg (milligram) /0.8 mL (millilitre).
|
Panel 2 RO7239361
n=1 Participants
RO7239361 subcutaneous injections on specified days. The Panel 2 dose targets achievement of \> 85% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 2 body weight tier doses are =\>15kg to =\< 45kg at a dose of 12.5 mg /0.25 mL and =\>45kg at a dose of 20 mg /0.4 mL
|
Panel 3 and Expansion RO7239361
n=7 Participants
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of \> 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =\>15kg to =\< 45kg at a dose of 35 mg /0.7 mL and =\>45kg at a dose of 50 mg /1.0 mL
|
Expansion Panel RO7239361 35mg
n=16 Participants
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of \> 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =\>15kg to =\< 45kg at a dose of 35 mg /0.7 mL and =\>45kg at a dose of 50 mg /1.0 mL
|
Expansion Panel RO7239361 50mg
n=1 Participants
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of \> 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =\>15kg to =\< 45kg at a dose of 35 mg /0.7 mL and =\>45kg at a dose of 50 mg /1.0 mL
|
|---|---|---|---|---|---|---|
|
RO7239361 Trough Concentrations
Day 1
|
825.343 ng/mL
Geometric Coefficient of Variation 23
|
2115.951 ng/mL
Geometric Coefficient of Variation 20
|
—
|
6559.364 ng/mL
Geometric Coefficient of Variation 26
|
6017.978 ng/mL
Geometric Coefficient of Variation 23
|
5020.000 ng/mL
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation not evaluable as only one participant was included at this dose and therefore there was no dispersion.
|
|
RO7239361 Trough Concentrations
Day 29
|
2015.695 ng/mL
Geometric Coefficient of Variation 32
|
5107.668 ng/mL
Geometric Coefficient of Variation 25
|
—
|
14110.005 ng/mL
Geometric Coefficient of Variation 34
|
15094.455 ng/mL
Geometric Coefficient of Variation 19
|
NA ng/mL
Geometric Coefficient of Variation NA
Not evaluable, no sample taken
|
|
RO7239361 Trough Concentrations
Day 168
|
2438.595 ng/mL
Geometric Coefficient of Variation 16
|
6100.315 ng/mL
Geometric Coefficient of Variation 25
|
6340.000 ng/mL
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation not evaluable as only one participant was included at this dose and therefore there was no dispersion.
|
19923.182 ng/mL
Geometric Coefficient of Variation 41
|
12580.299 ng/mL
Geometric Coefficient of Variation 41
|
26200.000 ng/mL
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation not evaluable as only one participant was included at this dose and therefore there was no dispersion.
|
|
RO7239361 Trough Concentrations
Day 15
|
1258.746 ng/mL
Geometric Coefficient of Variation 35
|
3697.590 ng/mL
Geometric Coefficient of Variation 20
|
—
|
9957.352 ng/mL
Geometric Coefficient of Variation 34
|
9944.183 ng/mL
Geometric Coefficient of Variation 24
|
9980.000 ng/mL
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation not evaluable as only one participant was included at this dose and therefore there was no dispersion.
|
|
RO7239361 Trough Concentrations
Day 22
|
1640.052 ng/mL
Geometric Coefficient of Variation 15
|
4220.280 ng/mL
Geometric Coefficient of Variation 32
|
—
|
12383.747 ng/mL
Geometric Coefficient of Variation 30
|
13215.188 ng/mL
Geometric Coefficient of Variation 24
|
NA ng/mL
Geometric Coefficient of Variation NA
Not evaluable, no sample taken
|
|
RO7239361 Trough Concentrations
Day 84
|
2179.385 ng/mL
Geometric Coefficient of Variation 26
|
6484.502 ng/mL
Geometric Coefficient of Variation 19
|
—
|
19332.421 ng/mL
Geometric Coefficient of Variation 20
|
18789.382 ng/mL
Geometric Coefficient of Variation 18
|
27800.000 ng/mL
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation not evaluable as only one participant was included at this dose and therefore there was no dispersion.
|
SECONDARY outcome
Timeframe: Day 8 through Week 24, baseline and on-study information represented in table.A positive ADA sample is defined as one in which the presence of detectable ADAs is confirmed to be specific to RO7239361. A participant is considered as ADA positive if, after initiation of treatment, they have an ADA positive relative to baseline sample. Participants in Panel 1 received 4 mg RO7239361; participants in Panel 2 received either 12.5 mg (weight between 15 and 45 kg) or 20 mg (weight \>45 kg) RO7239361, and participants in Panel 3 and the Expansion Panel received either 35 mg (weight between 15 and 45 kg) or 50 mg (weight \>45 kg) RO7239361.
Outcome measures
| Measure |
Placebo
n=11 Participants
Placebo subcutaneous injections on specified days
|
Panel 1 RO7239361
n=7 Participants
RO7239361 subcutaneous injections on specified days. The Panel 1 dose targets achievement of \> 50% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. The Panel 1 body weight tier dose is \>15kg at a dose of 4 mg (milligram) /0.8 mL (millilitre).
|
Panel 2 RO7239361
n=6 Participants
RO7239361 subcutaneous injections on specified days. The Panel 2 dose targets achievement of \> 85% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 2 body weight tier doses are =\>15kg to =\< 45kg at a dose of 12.5 mg /0.25 mL and =\>45kg at a dose of 20 mg /0.4 mL
|
Panel 3 and Expansion RO7239361
n=19 Participants
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of \> 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =\>15kg to =\< 45kg at a dose of 35 mg /0.7 mL and =\>45kg at a dose of 50 mg /1.0 mL
|
Expansion Panel RO7239361 35mg
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of \> 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =\>15kg to =\< 45kg at a dose of 35 mg /0.7 mL and =\>45kg at a dose of 50 mg /1.0 mL
|
Expansion Panel RO7239361 50mg
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of \> 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =\>15kg to =\< 45kg at a dose of 35 mg /0.7 mL and =\>45kg at a dose of 50 mg /1.0 mL
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Positive Anti-RO7239361 Antibodies (ADA) Assessment, Double-Blind Phase
Baseline (BL): ADA Positive
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Percentage of Participants With Positive Anti-RO7239361 Antibodies (ADA) Assessment, Double-Blind Phase
BL: ADA Negative
|
0 percentage of participants
|
71.4 percentage of participants
|
100.0 percentage of participants
|
89.5 percentage of participants
|
—
|
—
|
|
Percentage of Participants With Positive Anti-RO7239361 Antibodies (ADA) Assessment, Double-Blind Phase
BL: Missing
|
100.0 percentage of participants
|
28.6 percentage of participants
|
0 percentage of participants
|
10.5 percentage of participants
|
—
|
—
|
|
Percentage of Participants With Positive Anti-RO7239361 Antibodies (ADA) Assessment, Double-Blind Phase
On-treatment: ADA Positive
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Percentage of Participants With Positive Anti-RO7239361 Antibodies (ADA) Assessment, Double-Blind Phase
On-treatment: Persistent Positive
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Percentage of Participants With Positive Anti-RO7239361 Antibodies (ADA) Assessment, Double-Blind Phase
On-treatment: Only last sample Positive
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Percentage of Participants With Positive Anti-RO7239361 Antibodies (ADA) Assessment, Double-Blind Phase
On-treatment: Other Positive
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Percentage of Participants With Positive Anti-RO7239361 Antibodies (ADA) Assessment, Double-Blind Phase
On-treatment: ADA Negative
|
0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants With Positive Anti-RO7239361 Antibodies (ADA) Assessment, Double-Blind Phase
On-treatment: ADA Negative, BL Positive, No Boost
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Percentage of Participants With Positive Anti-RO7239361 Antibodies (ADA) Assessment, Double-Blind Phase
On-treatment: Missing
|
100.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 8 through Week 72, baseline and on-study information represented in table.A positive ADA sample is defined as one in which the presence of detectable ADAs is confirmed to be specific to RO7239361. A participant is considered as ADA positive if, after initiation of treatment, they have an ADA positive relative to baseline sample. Double-blind phase data for placebo participants is not included. Placebo participants in each arm moved on to RO7239361 upon entering the open label phase. Participants in Panel 1 received 4 mg RO7239361; participants in Panel 2 received either 12.5 mg (weight between 15 and 45 kg) or 20 mg (weight \>45 kg) RO7239361, and participants in Panel 3 and the Expansion Panel received either 35 mg (weight between 15 and 45 kg) or 50 mg (weight \>45 kg) RO7239361.
Outcome measures
| Measure |
Placebo
n=9 Participants
Placebo subcutaneous injections on specified days
|
Panel 1 RO7239361
n=8 Participants
RO7239361 subcutaneous injections on specified days. The Panel 1 dose targets achievement of \> 50% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. The Panel 1 body weight tier dose is \>15kg at a dose of 4 mg (milligram) /0.8 mL (millilitre).
|
Panel 2 RO7239361
n=26 Participants
RO7239361 subcutaneous injections on specified days. The Panel 2 dose targets achievement of \> 85% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 2 body weight tier doses are =\>15kg to =\< 45kg at a dose of 12.5 mg /0.25 mL and =\>45kg at a dose of 20 mg /0.4 mL
|
Panel 3 and Expansion RO7239361
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of \> 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =\>15kg to =\< 45kg at a dose of 35 mg /0.7 mL and =\>45kg at a dose of 50 mg /1.0 mL
|
Expansion Panel RO7239361 35mg
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of \> 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =\>15kg to =\< 45kg at a dose of 35 mg /0.7 mL and =\>45kg at a dose of 50 mg /1.0 mL
|
Expansion Panel RO7239361 50mg
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of \> 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =\>15kg to =\< 45kg at a dose of 35 mg /0.7 mL and =\>45kg at a dose of 50 mg /1.0 mL
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Positive Anti-RO7239361 Antibodies (ADA) Assessment up to Week 72
BL: ADA Negative
|
77.8 percentage of participants
|
87.5 percentage of participants
|
88.5 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Positive Anti-RO7239361 Antibodies (ADA) Assessment up to Week 72
BL: Missing
|
22.2 percentage of participants
|
12.5 percentage of participants
|
11.5 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Positive Anti-RO7239361 Antibodies (ADA) Assessment up to Week 72
On-treatment: ADA Positive
|
0 percentage of participants
|
0 percentage of participants
|
3.8 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Positive Anti-RO7239361 Antibodies (ADA) Assessment up to Week 72
On-treatment: Persistent Positive
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Positive Anti-RO7239361 Antibodies (ADA) Assessment up to Week 72
On-treatment: Other Positive
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Positive Anti-RO7239361 Antibodies (ADA) Assessment up to Week 72
On-treatment: ADA Negative
|
100.0 percentage of participants
|
100.0 percentage of participants
|
96.2 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Positive Anti-RO7239361 Antibodies (ADA) Assessment up to Week 72
On-treatment: ADA Negative, BL Positive, No Boost
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Positive Anti-RO7239361 Antibodies (ADA) Assessment up to Week 72
On-treatment: Missing
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Positive Anti-RO7239361 Antibodies (ADA) Assessment up to Week 72
Baseline (BL): ADA Positive
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Positive Anti-RO7239361 Antibodies (ADA) Assessment up to Week 72
On-treatment: Only last sample Positive
|
0 percentage of participants
|
0 percentage of participants
|
3.8 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline through Week 24Population: The pharmacodynamics (PD) data set included all available data from subjects for whom PD measurements were available at baseline and at least one other timepoint.
Participants in Panel 1 received 4 mg RO7239361; participants in Panel 2 received either 12.5 mg (weight between 15 and 45 kg) or 20 mg (weight \>45 kg) RO7239361, and participants in Panel 3 and the Expansion Panel received either 35 mg (weight between 15 and 45 kg) or 50 mg (weight \>45 kg) RO7239361.
Outcome measures
| Measure |
Placebo
n=11 Participants
Placebo subcutaneous injections on specified days
|
Panel 1 RO7239361
n=7 Participants
RO7239361 subcutaneous injections on specified days. The Panel 1 dose targets achievement of \> 50% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. The Panel 1 body weight tier dose is \>15kg at a dose of 4 mg (milligram) /0.8 mL (millilitre).
|
Panel 2 RO7239361
n=6 Participants
RO7239361 subcutaneous injections on specified days. The Panel 2 dose targets achievement of \> 85% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 2 body weight tier doses are =\>15kg to =\< 45kg at a dose of 12.5 mg /0.25 mL and =\>45kg at a dose of 20 mg /0.4 mL
|
Panel 3 and Expansion RO7239361
n=19 Participants
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of \> 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =\>15kg to =\< 45kg at a dose of 35 mg /0.7 mL and =\>45kg at a dose of 50 mg /1.0 mL
|
Expansion Panel RO7239361 35mg
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of \> 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =\>15kg to =\< 45kg at a dose of 35 mg /0.7 mL and =\>45kg at a dose of 50 mg /1.0 mL
|
Expansion Panel RO7239361 50mg
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of \> 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =\>15kg to =\< 45kg at a dose of 35 mg /0.7 mL and =\>45kg at a dose of 50 mg /1.0 mL
|
|---|---|---|---|---|---|---|
|
Serum Concentration of Free Myostatin in the Double-Blind Phase
Day 4
|
1356.6 pg/mL
Standard Deviation 641.27
|
421.4 pg/mL
Standard Deviation 70.60
|
321.3 pg/mL
Standard Deviation 165.91
|
58.3 pg/mL
Standard Deviation 33.20
|
—
|
—
|
|
Serum Concentration of Free Myostatin in the Double-Blind Phase
Day 5
|
1438.2 pg/mL
Standard Deviation 809.18
|
446.6 pg/mL
Standard Deviation 108.81
|
357.8 pg/mL
Standard Deviation 166.27
|
66.1 pg/mL
Standard Deviation 39.07
|
—
|
—
|
|
Serum Concentration of Free Myostatin in the Double-Blind Phase
Day 15
|
1266.9 pg/mL
Standard Deviation 611.27
|
478.4 pg/mL
Standard Deviation 111.44
|
280.8 pg/mL
Standard Deviation 148.53
|
54.8 pg/mL
Standard Deviation 61.85
|
—
|
—
|
|
Serum Concentration of Free Myostatin in the Double-Blind Phase
Day 22
|
1317.1 pg/mL
Standard Deviation 728.48
|
382.4 pg/mL
Standard Deviation 82.58
|
284.8 pg/mL
Standard Deviation 324.16
|
35.3 pg/mL
Standard Deviation 51.45
|
—
|
—
|
|
Serum Concentration of Free Myostatin in the Double-Blind Phase
Day 29
|
1214.0 pg/mL
Standard Deviation 676.80
|
372.3 pg/mL
Standard Deviation 79.97
|
179.0 pg/mL
Standard Deviation 137.39
|
24.8 pg/mL
Standard Deviation 27.24
|
—
|
—
|
|
Serum Concentration of Free Myostatin in the Double-Blind Phase
Baseline
|
1405.1 pg/mL
Standard Deviation 809.57
|
815.3 pg/mL
Standard Deviation 155.14
|
1391.3 pg/mL
Standard Deviation 1084.97
|
1121.8 pg/mL
Standard Deviation 526.45
|
—
|
—
|
|
Serum Concentration of Free Myostatin in the Double-Blind Phase
Day 8
|
1014.2 pg/mL
Standard Deviation 549.26
|
522.7 pg/mL
Standard Deviation 131.51
|
479.2 pg/mL
Standard Deviation 319.13
|
206.8 pg/mL
Standard Deviation 419.21
|
—
|
—
|
|
Serum Concentration of Free Myostatin in the Double-Blind Phase
Day 33
|
1141.4 pg/mL
Standard Deviation 606.99
|
291.1 pg/mL
Standard Deviation 77.55
|
115.7 pg/mL
Standard Deviation 84.49
|
24.3 pg/mL
Standard Deviation 30.64
|
—
|
—
|
|
Serum Concentration of Free Myostatin in the Double-Blind Phase
Week 12
|
1366.5 pg/mL
Standard Deviation 631.28
|
307.8 pg/mL
Standard Deviation 97.84
|
110.8 pg/mL
Standard Deviation 49.80
|
16.2 pg/mL
Standard Deviation 11.60
|
—
|
—
|
|
Serum Concentration of Free Myostatin in the Double-Blind Phase
Week 24
|
1194.0 pg/mL
Standard Deviation 599.59
|
297.1 pg/mL
Standard Deviation 74.62
|
160.8 pg/mL
Standard Deviation 122.75
|
23.4 pg/mL
Standard Deviation 25.34
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline through Week 24Population: The pharmacodynamics (PD) data set included all available data from subjects for whom PD measurements were available at baseline and at least one other timepoint.
Participants in Panel 1 received 4 mg RO7239361; participants in Panel 2 received either 12.5 mg (weight between 15 and 45 kg) or 20 mg (weight \>45 kg) RO7239361, and participants in Panel 3 and the Expansion Panel received either 35 mg (weight between 15 and 45 kg) or 50 mg (weight \>45 kg) RO7239361.
Outcome measures
| Measure |
Placebo
n=11 Participants
Placebo subcutaneous injections on specified days
|
Panel 1 RO7239361
n=7 Participants
RO7239361 subcutaneous injections on specified days. The Panel 1 dose targets achievement of \> 50% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. The Panel 1 body weight tier dose is \>15kg at a dose of 4 mg (milligram) /0.8 mL (millilitre).
|
Panel 2 RO7239361
n=6 Participants
RO7239361 subcutaneous injections on specified days. The Panel 2 dose targets achievement of \> 85% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 2 body weight tier doses are =\>15kg to =\< 45kg at a dose of 12.5 mg /0.25 mL and =\>45kg at a dose of 20 mg /0.4 mL
|
Panel 3 and Expansion RO7239361
n=19 Participants
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of \> 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =\>15kg to =\< 45kg at a dose of 35 mg /0.7 mL and =\>45kg at a dose of 50 mg /1.0 mL
|
Expansion Panel RO7239361 35mg
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of \> 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =\>15kg to =\< 45kg at a dose of 35 mg /0.7 mL and =\>45kg at a dose of 50 mg /1.0 mL
|
Expansion Panel RO7239361 50mg
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of \> 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =\>15kg to =\< 45kg at a dose of 35 mg /0.7 mL and =\>45kg at a dose of 50 mg /1.0 mL
|
|---|---|---|---|---|---|---|
|
Percent Inhibition of Free Myostatin in the Double-Blind Phase
Day 4
|
0.595 percentage inhibition
Standard Deviation 23.6952
|
49.689 percentage inhibition
Standard Deviation 11.7394
|
73.533 percentage inhibition
Standard Deviation 9.8637
|
95.334 percentage inhibition
Standard Deviation 2.4477
|
—
|
—
|
|
Percent Inhibition of Free Myostatin in the Double-Blind Phase
Day 8
|
23.917 percentage inhibition
Standard Deviation 31.1378
|
38.411 percentage inhibition
Standard Deviation 7.0320
|
62.524 percentage inhibition
Standard Deviation 9.7074
|
84.797 percentage inhibition
Standard Deviation 22.1958
|
—
|
—
|
|
Percent Inhibition of Free Myostatin in the Double-Blind Phase
Day 15
|
5.744 percentage inhibition
Standard Deviation 18.6190
|
40.763 percentage inhibition
Standard Deviation 10.0071
|
77.090 percentage inhibition
Standard Deviation 6.2939
|
96.488 percentage inhibition
Standard Deviation 1.9665
|
—
|
—
|
|
Percent Inhibition of Free Myostatin in the Double-Blind Phase
Day 22
|
5.561 percentage inhibition
Standard Deviation 11.7425
|
51.836 percentage inhibition
Standard Deviation 9.3488
|
81.693 percentage inhibition
Standard Deviation 5.7392
|
97.927 percentage inhibition
Standard Deviation 1.1259
|
—
|
—
|
|
Percent Inhibition of Free Myostatin in the Double-Blind Phase
Day 29
|
12.599 percentage inhibition
Standard Deviation 16.1591
|
52.926 percentage inhibition
Standard Deviation 6.6001
|
86.894 percentage inhibition
Standard Deviation 2.9590
|
98.202 percentage inhibition
Standard Deviation 1.4590
|
—
|
—
|
|
Percent Inhibition of Free Myostatin in the Double-Blind Phase
Day 33
|
15.662 percentage inhibition
Standard Deviation 17.3640
|
61.796 percentage inhibition
Standard Deviation 4.5760
|
91.557 percentage inhibition
Standard Deviation 2.6444
|
97.042 percentage inhibition
Standard Deviation 5.4443
|
—
|
—
|
|
Percent Inhibition of Free Myostatin in the Double-Blind Phase
Week 12
|
5.289 percentage inhibition
Standard Deviation 15.5082
|
60.254 percentage inhibition
Standard Deviation 9.4283
|
92.454 percentage inhibition
Standard Deviation 1.7243
|
98.415 percentage inhibition
Standard Deviation 1.2882
|
—
|
—
|
|
Percent Inhibition of Free Myostatin in the Double-Blind Phase
Week 24
|
9.910 percentage inhibition
Standard Deviation 17.8109
|
63.790 percentage inhibition
Standard Deviation 5.7031
|
88.392 percentage inhibition
Standard Deviation 5.1669
|
97.921 percentage inhibition
Standard Deviation 2.2143
|
—
|
—
|
|
Percent Inhibition of Free Myostatin in the Double-Blind Phase
Day 5
|
3.114 percentage inhibition
Standard Deviation 20.3395
|
46.506 percentage inhibition
Standard Deviation 9.0917
|
69.700 percentage inhibition
Standard Deviation 10.3411
|
94.545 percentage inhibition
Standard Deviation 2.7608
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline through Week 24Population: The pharmacodynamics (PD) data set included all available data from subjects for whom PD measurements were available at baseline and at least one other timepoint.
Participants in Panel 1 received 4 mg RO7239361; participants in Panel 2 received either 12.5 mg (weight between 15 and 45 kg) or 20 mg (weight \>45 kg) RO7239361, and participants in Panel 3 and the Expansion Panel received either 35 mg (weight between 15 and 45 kg) or 50 mg (weight \>45 kg) RO7239361.
Outcome measures
| Measure |
Placebo
n=11 Participants
Placebo subcutaneous injections on specified days
|
Panel 1 RO7239361
n=7 Participants
RO7239361 subcutaneous injections on specified days. The Panel 1 dose targets achievement of \> 50% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. The Panel 1 body weight tier dose is \>15kg at a dose of 4 mg (milligram) /0.8 mL (millilitre).
|
Panel 2 RO7239361
n=6 Participants
RO7239361 subcutaneous injections on specified days. The Panel 2 dose targets achievement of \> 85% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 2 body weight tier doses are =\>15kg to =\< 45kg at a dose of 12.5 mg /0.25 mL and =\>45kg at a dose of 20 mg /0.4 mL
|
Panel 3 and Expansion RO7239361
n=19 Participants
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of \> 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =\>15kg to =\< 45kg at a dose of 35 mg /0.7 mL and =\>45kg at a dose of 50 mg /1.0 mL
|
Expansion Panel RO7239361 35mg
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of \> 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =\>15kg to =\< 45kg at a dose of 35 mg /0.7 mL and =\>45kg at a dose of 50 mg /1.0 mL
|
Expansion Panel RO7239361 50mg
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of \> 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =\>15kg to =\< 45kg at a dose of 35 mg /0.7 mL and =\>45kg at a dose of 50 mg /1.0 mL
|
|---|---|---|---|---|---|---|
|
Serum Concentration of Drug-Myostatin Complex in the Double-Blind Phase
Day 4
|
1.178 ng/mL
Standard Deviation 1.8833
|
5.070 ng/mL
Standard Deviation 0.9456
|
12.606 ng/mL
Standard Deviation 5.7623
|
14.696 ng/mL
Standard Deviation 5.7926
|
—
|
—
|
|
Serum Concentration of Drug-Myostatin Complex in the Double-Blind Phase
Day 5
|
2.119 ng/mL
Standard Deviation 2.9826
|
5.845 ng/mL
Standard Deviation 2.5725
|
14.856 ng/mL
Standard Deviation 7.6131
|
17.308 ng/mL
Standard Deviation 7.5955
|
—
|
—
|
|
Serum Concentration of Drug-Myostatin Complex in the Double-Blind Phase
Day 8
|
4.924 ng/mL
Standard Deviation 12.9975
|
7.041 ng/mL
Standard Deviation 2.3470
|
19.906 ng/mL
Standard Deviation 9.8664
|
21.609 ng/mL
Standard Deviation 11.0880
|
—
|
—
|
|
Serum Concentration of Drug-Myostatin Complex in the Double-Blind Phase
Day 15
|
0.613 ng/mL
Standard Deviation 0.2102
|
14.067 ng/mL
Standard Deviation 7.1096
|
29.229 ng/mL
Standard Deviation 10.4929
|
45.289 ng/mL
Standard Deviation 18.7600
|
—
|
—
|
|
Serum Concentration of Drug-Myostatin Complex in the Double-Blind Phase
Day 22
|
1.326 ng/mL
Standard Deviation 1.3410
|
11.985 ng/mL
Standard Deviation 4.8243
|
36.811 ng/mL
Standard Deviation 26.8560
|
52.841 ng/mL
Standard Deviation 21.5542
|
—
|
—
|
|
Serum Concentration of Drug-Myostatin Complex in the Double-Blind Phase
Day 29
|
1.593 ng/mL
Standard Deviation 3.1007
|
15.735 ng/mL
Standard Deviation 4.2010
|
43.236 ng/mL
Standard Deviation 34.0300
|
67.255 ng/mL
Standard Deviation 27.9376
|
—
|
—
|
|
Serum Concentration of Drug-Myostatin Complex in the Double-Blind Phase
Week 12
|
7.082 ng/mL
Standard Deviation 15.2289
|
28.556 ng/mL
Standard Deviation 22.7890
|
79.555 ng/mL
Standard Deviation 17.2126
|
88.402 ng/mL
Standard Deviation 29.8080
|
—
|
—
|
|
Serum Concentration of Drug-Myostatin Complex in the Double-Blind Phase
Week 24
|
3.589 ng/mL
Standard Deviation 7.8108
|
25.997 ng/mL
Standard Deviation 6.4384
|
83.262 ng/mL
Standard Deviation 64.2281
|
101.406 ng/mL
Standard Deviation 45.4197
|
—
|
—
|
|
Serum Concentration of Drug-Myostatin Complex in the Double-Blind Phase
Day 33
|
1.157 ng/mL
Standard Deviation 1.0036
|
18.542 ng/mL
Standard Deviation 3.9874
|
46.279 ng/mL
Standard Deviation 24.1457
|
77.142 ng/mL
Standard Deviation 32.4153
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline through Week 24Population: The pharmacodynamics (PD) data set includes all available data from subjects for whom PD measurements are available at baseline and at least one other timepoint.
Ratio of contractile vs non-contractile content is contractile content / non-contractile content. Fold change from baseline of the ratio is defined as the ratio of fold change from baseline of contractile content vs fold change from baseline of non-contractile content. Right thigh measurements. W12 = Week 12, W24 = Week 24. Participants in Panel 1 received 4 mg RO7239361; participants in Panel 2 received either 12.5 mg (weight between 15 and 45 kg) or 20 mg (weight \>45 kg) RO7239361, and participants in Panel 3 and the Expansion Panel received either 35 mg (weight between 15 and 45 kg) or 50 mg (weight \>45 kg) RO7239361.
Outcome measures
| Measure |
Placebo
n=11 Participants
Placebo subcutaneous injections on specified days
|
Panel 1 RO7239361
n=7 Participants
RO7239361 subcutaneous injections on specified days. The Panel 1 dose targets achievement of \> 50% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. The Panel 1 body weight tier dose is \>15kg at a dose of 4 mg (milligram) /0.8 mL (millilitre).
|
Panel 2 RO7239361
n=6 Participants
RO7239361 subcutaneous injections on specified days. The Panel 2 dose targets achievement of \> 85% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 2 body weight tier doses are =\>15kg to =\< 45kg at a dose of 12.5 mg /0.25 mL and =\>45kg at a dose of 20 mg /0.4 mL
|
Panel 3 and Expansion RO7239361
n=6 Participants
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of \> 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =\>15kg to =\< 45kg at a dose of 35 mg /0.7 mL and =\>45kg at a dose of 50 mg /1.0 mL
|
Expansion Panel RO7239361 35mg
n=13 Participants
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of \> 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =\>15kg to =\< 45kg at a dose of 35 mg /0.7 mL and =\>45kg at a dose of 50 mg /1.0 mL
|
Expansion Panel RO7239361 50mg
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of \> 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =\>15kg to =\< 45kg at a dose of 35 mg /0.7 mL and =\>45kg at a dose of 50 mg /1.0 mL
|
|---|---|---|---|---|---|---|
|
Fold Change From Baseline in Contractile Versus Non-contractile Content for Muscles in the Right Thigh in the Double-Blind Phase
W24: ADDUCTOR LONGUS
|
0.81 Fold Change
Standard Error 0.290
|
1.14 Fold Change
Standard Error 0.269
|
1.11 Fold Change
Standard Error 0.471
|
1.36 Fold Change
Standard Error 0.718
|
2.41 Fold Change
Standard Error 0.813
|
—
|
|
Fold Change From Baseline in Contractile Versus Non-contractile Content for Muscles in the Right Thigh in the Double-Blind Phase
W24: ADDUCTOR MAGNUS
|
0.66 Fold Change
Standard Error 0.112
|
0.94 Fold Change
Standard Error 0.296
|
0.59 Fold Change
Standard Error 0.144
|
1.61 Fold Change
Standard Error 0.697
|
1.14 Fold Change
Standard Error 0.146
|
—
|
|
Fold Change From Baseline in Contractile Versus Non-contractile Content for Muscles in the Right Thigh in the Double-Blind Phase
W12: ADDUCTOR LONGUS
|
1.04 Fold Change
Standard Error 0.291
|
0.95 Fold Change
Standard Error 0.088
|
1.16 Fold Change
Standard Error 0.330
|
2.27 Fold Change
Standard Error 1.122
|
2.36 Fold Change
Standard Error 0.875
|
—
|
|
Fold Change From Baseline in Contractile Versus Non-contractile Content for Muscles in the Right Thigh in the Double-Blind Phase
W12: ADDUCTOR MAGNUS
|
0.69 Fold Change
Standard Error 0.104
|
0.88 Fold Change
Standard Error 0.283
|
1.12 Fold Change
Standard Error 0.281
|
0.93 Fold Change
Standard Error 0.255
|
1.04 Fold Change
Standard Error 0.101
|
—
|
|
Fold Change From Baseline in Contractile Versus Non-contractile Content for Muscles in the Right Thigh in the Double-Blind Phase
W12: BICEPS FEMORIS LONG
|
0.78 Fold Change
Standard Error 0.221
|
0.94 Fold Change
Standard Error 0.304
|
1.57 Fold Change
Standard Error 0.556
|
1.10 Fold Change
Standard Error 0.280
|
1.26 Fold Change
Standard Error 0.237
|
—
|
|
Fold Change From Baseline in Contractile Versus Non-contractile Content for Muscles in the Right Thigh in the Double-Blind Phase
W12: BICEPS FEMORIS SHORT
|
0.92 Fold Change
Standard Error 0.269
|
2.77 Fold Change
Standard Error 1.144
|
2.03 Fold Change
Standard Error 1.564
|
0.79 Fold Change
Standard Error 0.162
|
1.31 Fold Change
Standard Error 0.301
|
—
|
|
Fold Change From Baseline in Contractile Versus Non-contractile Content for Muscles in the Right Thigh in the Double-Blind Phase
W12: GRACILIS
|
1.13 Fold Change
Standard Error 0.318
|
7.57 Fold Change
Standard Error 5.372
|
0.98 Fold Change
Standard Error 0.176
|
3.41 Fold Change
Standard Error 2.474
|
5.42 Fold Change
Standard Error 3.871
|
—
|
|
Fold Change From Baseline in Contractile Versus Non-contractile Content for Muscles in the Right Thigh in the Double-Blind Phase
W12:RECTUS FEMORIS
|
0.74 Fold Change
Standard Error 0.185
|
0.55 Fold Change
Standard Error 0.134
|
4.49 Fold Change
Standard Error 2.729
|
0.99 Fold Change
Standard Error 0.345
|
2.02 Fold Change
Standard Error 0.764
|
—
|
|
Fold Change From Baseline in Contractile Versus Non-contractile Content for Muscles in the Right Thigh in the Double-Blind Phase
W12: SARTORIUS
|
1.78 Fold Change
Standard Error 0.771
|
0.69 Fold Change
Standard Error 0.307
|
1.04 Fold Change
Standard Error 0.443
|
0.90 Fold Change
Standard Error 0.396
|
2.00 Fold Change
Standard Error 0.683
|
—
|
|
Fold Change From Baseline in Contractile Versus Non-contractile Content for Muscles in the Right Thigh in the Double-Blind Phase
W12: SEMIMEMBRANOSUS
|
0.82 Fold Change
Standard Error 0.230
|
0.82 Fold Change
Standard Error 0.284
|
1.47 Fold Change
Standard Error 0.777
|
0.86 Fold Change
Standard Error 0.276
|
1.31 Fold Change
Standard Error 0.194
|
—
|
|
Fold Change From Baseline in Contractile Versus Non-contractile Content for Muscles in the Right Thigh in the Double-Blind Phase
W12: SEMITENDINOSUS
|
0.78 Fold Change
Standard Error 0.262
|
2.95 Fold Change
Standard Error 1.016
|
1.31 Fold Change
Standard Error 0.260
|
1.42 Fold Change
Standard Error 0.317
|
1.17 Fold Change
Standard Error 0.160
|
—
|
|
Fold Change From Baseline in Contractile Versus Non-contractile Content for Muscles in the Right Thigh in the Double-Blind Phase
W12: VASTUS INTERMEDIUS
|
2.59 Fold Change
Standard Error 1.749
|
1.11 Fold Change
Standard Error 0.292
|
0.62 Fold Change
Standard Error 0.258
|
0.86 Fold Change
Standard Error 0.157
|
1.64 Fold Change
Standard Error 0.377
|
—
|
|
Fold Change From Baseline in Contractile Versus Non-contractile Content for Muscles in the Right Thigh in the Double-Blind Phase
W12: VASTUS LATERALIS
|
0.66 Fold Change
Standard Error 0.160
|
0.89 Fold Change
Standard Error 0.272
|
1.10 Fold Change
Standard Error 0.333
|
1.78 Fold Change
Standard Error 0.455
|
1.70 Fold Change
Standard Error 0.334
|
—
|
|
Fold Change From Baseline in Contractile Versus Non-contractile Content for Muscles in the Right Thigh in the Double-Blind Phase
W12: VASTUS MEDIALIS
|
1.08 Fold Change
Standard Error 0.269
|
1.26 Fold Change
Standard Error 0.112
|
2.97 Fold Change
Standard Error 1.981
|
0.85 Fold Change
Standard Error 0.280
|
5.96 Fold Change
Standard Error 3.376
|
—
|
|
Fold Change From Baseline in Contractile Versus Non-contractile Content for Muscles in the Right Thigh in the Double-Blind Phase
W24: BICEPS FEMORIS LONG
|
1.07 Fold Change
Standard Error 0.511
|
1.13 Fold Change
Standard Error 0.315
|
1.00 Fold Change
Standard Error 0.349
|
1.29 Fold Change
Standard Error 0.238
|
2.10 Fold Change
Standard Error 1.044
|
—
|
|
Fold Change From Baseline in Contractile Versus Non-contractile Content for Muscles in the Right Thigh in the Double-Blind Phase
W24: BICEPS FEMORIS SHORT
|
0.91 Fold Change
Standard Error 0.195
|
2.24 Fold Change
Standard Error 1.027
|
2.15 Fold Change
Standard Error 1.003
|
1.24 Fold Change
Standard Error 0.411
|
2.02 Fold Change
Standard Error 0.416
|
—
|
|
Fold Change From Baseline in Contractile Versus Non-contractile Content for Muscles in the Right Thigh in the Double-Blind Phase
W24: VASTUS INTERMEDIUS
|
0.95 Fold Change
Standard Error 0.412
|
1.47 Fold Change
Standard Error 0.446
|
0.63 Fold Change
Standard Error 0.355
|
0.96 Fold Change
Standard Error 0.095
|
1.47 Fold Change
Standard Error 0.318
|
—
|
|
Fold Change From Baseline in Contractile Versus Non-contractile Content for Muscles in the Right Thigh in the Double-Blind Phase
W24: VASTUS LATERALIS
|
0.78 Fold Change
Standard Error 0.159
|
1.88 Fold Change
Standard Error 0.905
|
1.45 Fold Change
Standard Error 0.596
|
1.43 Fold Change
Standard Error 0.256
|
2.03 Fold Change
Standard Error 0.484
|
—
|
|
Fold Change From Baseline in Contractile Versus Non-contractile Content for Muscles in the Right Thigh in the Double-Blind Phase
W24: VASTUS MEDIALIS
|
2.14 Fold Change
Standard Error 0.889
|
5.16 Fold Change
Standard Error 3.580
|
6.01 Fold Change
Standard Error 5.478
|
1.29 Fold Change
Standard Error 0.474
|
3.50 Fold Change
Standard Error 1.390
|
—
|
|
Fold Change From Baseline in Contractile Versus Non-contractile Content for Muscles in the Right Thigh in the Double-Blind Phase
W24: GRACILIS
|
1.43 Fold Change
Standard Error 0.686
|
3.03 Fold Change
Standard Error 2.564
|
1.37 Fold Change
Standard Error 0.465
|
1.45 Fold Change
Standard Error 0.748
|
5.17 Fold Change
Standard Error 3.540
|
—
|
|
Fold Change From Baseline in Contractile Versus Non-contractile Content for Muscles in the Right Thigh in the Double-Blind Phase
W24:RECTUS FEMORIS
|
0.94 Fold Change
Standard Error 0.256
|
0.84 Fold Change
Standard Error 0.220
|
7.43 Fold Change
Standard Error 6.216
|
0.80 Fold Change
Standard Error 0.262
|
3.01 Fold Change
Standard Error 1.612
|
—
|
|
Fold Change From Baseline in Contractile Versus Non-contractile Content for Muscles in the Right Thigh in the Double-Blind Phase
W24: SARTORIUS
|
1.90 Fold Change
Standard Error 0.872
|
0.73 Fold Change
Standard Error 0.207
|
0.78 Fold Change
Standard Error 0.375
|
3.24 Fold Change
Standard Error 1.850
|
2.45 Fold Change
Standard Error 0.842
|
—
|
|
Fold Change From Baseline in Contractile Versus Non-contractile Content for Muscles in the Right Thigh in the Double-Blind Phase
W24: SEMIMEMBRANOSUS
|
0.66 Fold Change
Standard Error 0.126
|
0.90 Fold Change
Standard Error 0.361
|
0.72 Fold Change
Standard Error 0.157
|
0.94 Fold Change
Standard Error 0.250
|
1.39 Fold Change
Standard Error 0.256
|
—
|
|
Fold Change From Baseline in Contractile Versus Non-contractile Content for Muscles in the Right Thigh in the Double-Blind Phase
W24: SEMITENDINOSUS
|
0.56 Fold Change
Standard Error 0.119
|
1.59 Fold Change
Standard Error 0.520
|
1.43 Fold Change
Standard Error 0.524
|
1.04 Fold Change
Standard Error 0.254
|
1.22 Fold Change
Standard Error 0.221
|
—
|
SECONDARY outcome
Timeframe: Baseline through Week 24Population: The pharmacodynamics (PD) data set includes all available data from subjects for whom PD measurements are available at baseline and at least one other timepoint.
Right thigh measurements. W12 = Week 12, W24 = Week 24. Participants in Panel 1 received 4 mg RO7239361; participants in Panel 2 received either 12.5 mg (weight between 15 and 45 kg) or 20 mg (weight \>45 kg) RO7239361, and participants in Panel 3 and the Expansion Panel received either 35 mg (weight between 15 and 45 kg) or 50 mg (weight \>45 kg) RO7239361.
Outcome measures
| Measure |
Placebo
n=11 Participants
Placebo subcutaneous injections on specified days
|
Panel 1 RO7239361
n=7 Participants
RO7239361 subcutaneous injections on specified days. The Panel 1 dose targets achievement of \> 50% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. The Panel 1 body weight tier dose is \>15kg at a dose of 4 mg (milligram) /0.8 mL (millilitre).
|
Panel 2 RO7239361
n=6 Participants
RO7239361 subcutaneous injections on specified days. The Panel 2 dose targets achievement of \> 85% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 2 body weight tier doses are =\>15kg to =\< 45kg at a dose of 12.5 mg /0.25 mL and =\>45kg at a dose of 20 mg /0.4 mL
|
Panel 3 and Expansion RO7239361
n=6 Participants
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of \> 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =\>15kg to =\< 45kg at a dose of 35 mg /0.7 mL and =\>45kg at a dose of 50 mg /1.0 mL
|
Expansion Panel RO7239361 35mg
n=13 Participants
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of \> 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =\>15kg to =\< 45kg at a dose of 35 mg /0.7 mL and =\>45kg at a dose of 50 mg /1.0 mL
|
Expansion Panel RO7239361 50mg
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of \> 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =\>15kg to =\< 45kg at a dose of 35 mg /0.7 mL and =\>45kg at a dose of 50 mg /1.0 mL
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Thigh Muscle Maximal Cross Sectional Area (CSAmax) in the Double-Blind Phase
W12: ADDUCTOR LONGUS
|
7.29 Percentage Change
Standard Error 16.559
|
8.31 Percentage Change
Standard Error 11.767
|
5.85 Percentage Change
Standard Error 11.074
|
14.61 Percentage Change
Standard Error 9.755
|
29.98 Percentage Change
Standard Error 8.530
|
—
|
|
Change From Baseline in Thigh Muscle Maximal Cross Sectional Area (CSAmax) in the Double-Blind Phase
W12: BICEPS FEMORIS SHORT
|
14.10 Percentage Change
Standard Error 7.724
|
7.45 Percentage Change
Standard Error 11.592
|
2.69 Percentage Change
Standard Error 13.733
|
18.68 Percentage Change
Standard Error 7.479
|
9.84 Percentage Change
Standard Error 3.882
|
—
|
|
Change From Baseline in Thigh Muscle Maximal Cross Sectional Area (CSAmax) in the Double-Blind Phase
W12: GRACILIS
|
20.14 Percentage Change
Standard Error 15.489
|
43.00 Percentage Change
Standard Error 28.539
|
15.28 Percentage Change
Standard Error 8.693
|
27.02 Percentage Change
Standard Error 5.686
|
23.22 Percentage Change
Standard Error 5.440
|
—
|
|
Change From Baseline in Thigh Muscle Maximal Cross Sectional Area (CSAmax) in the Double-Blind Phase
W12:RECTUS FEMORIS
|
-7.86 Percentage Change
Standard Error 14.391
|
10.33 Percentage Change
Standard Error 11.927
|
-3.56 Percentage Change
Standard Error 14.175
|
34.91 Percentage Change
Standard Error 6.037
|
16.01 Percentage Change
Standard Error 9.888
|
—
|
|
Change From Baseline in Thigh Muscle Maximal Cross Sectional Area (CSAmax) in the Double-Blind Phase
W12: SARTORIUS
|
11.26 Percentage Change
Standard Error 6.584
|
6.59 Percentage Change
Standard Error 11.952
|
-0.85 Percentage Change
Standard Error 6.383
|
10.81 Percentage Change
Standard Error 11.017
|
18.20 Percentage Change
Standard Error 5.519
|
—
|
|
Change From Baseline in Thigh Muscle Maximal Cross Sectional Area (CSAmax) in the Double-Blind Phase
W12: SEMIMEMBRANOSUS
|
39.11 Percentage Change
Standard Error 15.041
|
32.57 Percentage Change
Standard Error 19.133
|
16.56 Percentage Change
Standard Error 19.998
|
46.70 Percentage Change
Standard Error 16.480
|
31.01 Percentage Change
Standard Error 10.564
|
—
|
|
Change From Baseline in Thigh Muscle Maximal Cross Sectional Area (CSAmax) in the Double-Blind Phase
W12: SEMITENDINOSUS
|
25.03 Percentage Change
Standard Error 9.409
|
-1.24 Percentage Change
Standard Error 10.973
|
33.00 Percentage Change
Standard Error 26.730
|
36.69 Percentage Change
Standard Error 14.802
|
40.10 Percentage Change
Standard Error 10.180
|
—
|
|
Change From Baseline in Thigh Muscle Maximal Cross Sectional Area (CSAmax) in the Double-Blind Phase
W12: VASTUS INTERMEDIUS
|
10.47 Percentage Change
Standard Error 12.160
|
23.35 Percentage Change
Standard Error 12.704
|
-52.03 Percentage Change
Standard Error 71.421
|
-0.81 Percentage Change
Standard Error 19.353
|
10.44 Percentage Change
Standard Error 7.344
|
—
|
|
Change From Baseline in Thigh Muscle Maximal Cross Sectional Area (CSAmax) in the Double-Blind Phase
W12: VASTUS LATERALIS
|
31.47 Percentage Change
Standard Error 39.343
|
38.32 Percentage Change
Standard Error 19.570
|
14.08 Percentage Change
Standard Error 27.902
|
57.86 Percentage Change
Standard Error 34.026
|
22.73 Percentage Change
Standard Error 15.138
|
—
|
|
Change From Baseline in Thigh Muscle Maximal Cross Sectional Area (CSAmax) in the Double-Blind Phase
W12: VASTUS MEDIALIS
|
-17.89 Percentage Change
Standard Error 19.358
|
15.65 Percentage Change
Standard Error 8.463
|
-11.60 Percentage Change
Standard Error 15.849
|
21.14 Percentage Change
Standard Error 9.746
|
17.89 Percentage Change
Standard Error 6.788
|
—
|
|
Change From Baseline in Thigh Muscle Maximal Cross Sectional Area (CSAmax) in the Double-Blind Phase
W24: ADDUCTOR LONGUS
|
11.69 Percentage Change
Standard Error 15.626
|
23.41 Percentage Change
Standard Error 13.199
|
12.81 Percentage Change
Standard Error 16.393
|
17.15 Percentage Change
Standard Error 15.484
|
44.12 Percentage Change
Standard Error 13.323
|
—
|
|
Change From Baseline in Thigh Muscle Maximal Cross Sectional Area (CSAmax) in the Double-Blind Phase
W24: ADDUCTOR MAGNUS
|
34.17 Percentage Change
Standard Error 24.918
|
21.90 Percentage Change
Standard Error 12.345
|
-6.71 Percentage Change
Standard Error 37.311
|
45.05 Percentage Change
Standard Error 27.520
|
4.41 Percentage Change
Standard Error 52.393
|
—
|
|
Change From Baseline in Thigh Muscle Maximal Cross Sectional Area (CSAmax) in the Double-Blind Phase
W24: BICEPS FEMORIS LONG
|
39.21 Percentage Change
Standard Error 19.760
|
42.84 Percentage Change
Standard Error 22.086
|
-5.32 Percentage Change
Standard Error 29.140
|
33.70 Percentage Change
Standard Error 12.073
|
31.33 Percentage Change
Standard Error 13.370
|
—
|
|
Change From Baseline in Thigh Muscle Maximal Cross Sectional Area (CSAmax) in the Double-Blind Phase
W24: BICEPS FEMORIS SHORT
|
20.09 Percentage Change
Standard Error 9.818
|
11.83 Percentage Change
Standard Error 13.013
|
-0.44 Percentage Change
Standard Error 16.183
|
30.01 Percentage Change
Standard Error 13.494
|
18.60 Percentage Change
Standard Error 5.394
|
—
|
|
Change From Baseline in Thigh Muscle Maximal Cross Sectional Area (CSAmax) in the Double-Blind Phase
W24: GRACILIS
|
8.14 Percentage Change
Standard Error 7.148
|
18.72 Percentage Change
Standard Error 16.757
|
11.21 Percentage Change
Standard Error 5.461
|
48.95 Percentage Change
Standard Error 17.064
|
40.15 Percentage Change
Standard Error 8.382
|
—
|
|
Change From Baseline in Thigh Muscle Maximal Cross Sectional Area (CSAmax) in the Double-Blind Phase
W24:RECTUS FEMORIS
|
8.97 Percentage Change
Standard Error 10.214
|
7.68 Percentage Change
Standard Error 13.082
|
-10.01 Percentage Change
Standard Error 16.121
|
55.65 Percentage Change
Standard Error 27.535
|
38.40 Percentage Change
Standard Error 14.293
|
—
|
|
Change From Baseline in Thigh Muscle Maximal Cross Sectional Area (CSAmax) in the Double-Blind Phase
W24: SEMITENDINOSUS
|
32.00 Percentage Change
Standard Error 16.102
|
36.17 Percentage Change
Standard Error 23.285
|
24.16 Percentage Change
Standard Error 23.403
|
73.68 Percentage Change
Standard Error 17.594
|
62.55 Percentage Change
Standard Error 11.073
|
—
|
|
Change From Baseline in Thigh Muscle Maximal Cross Sectional Area (CSAmax) in the Double-Blind Phase
W24: VASTUS INTERMEDIUS
|
14.86 Percentage Change
Standard Error 15.072
|
43.01 Percentage Change
Standard Error 11.506
|
-68.05 Percentage Change
Standard Error 86.362
|
41.63 Percentage Change
Standard Error 34.926
|
22.55 Percentage Change
Standard Error 8.284
|
—
|
|
Change From Baseline in Thigh Muscle Maximal Cross Sectional Area (CSAmax) in the Double-Blind Phase
W24: VASTUS LATERALIS
|
12.95 Percentage Change
Standard Error 35.465
|
47.79 Percentage Change
Standard Error 26.178
|
32.64 Percentage Change
Standard Error 30.136
|
45.41 Percentage Change
Standard Error 43.774
|
46.87 Percentage Change
Standard Error 20.919
|
—
|
|
Change From Baseline in Thigh Muscle Maximal Cross Sectional Area (CSAmax) in the Double-Blind Phase
W24: VASTUS MEDIALIS
|
-9.09 Percentage Change
Standard Error 11.856
|
9.82 Percentage Change
Standard Error 6.965
|
-13.74 Percentage Change
Standard Error 29.664
|
10.46 Percentage Change
Standard Error 12.093
|
23.94 Percentage Change
Standard Error 11.321
|
—
|
|
Change From Baseline in Thigh Muscle Maximal Cross Sectional Area (CSAmax) in the Double-Blind Phase
W12: ADDUCTOR MAGNUS
|
31.01 Percentage Change
Standard Error 24.708
|
24.12 Percentage Change
Standard Error 11.804
|
-3.73 Percentage Change
Standard Error 29.037
|
53.20 Percentage Change
Standard Error 25.328
|
4.01 Percentage Change
Standard Error 54.787
|
—
|
|
Change From Baseline in Thigh Muscle Maximal Cross Sectional Area (CSAmax) in the Double-Blind Phase
W12: BICEPS FEMORIS LONG
|
34.24 Percentage Change
Standard Error 18.328
|
33.43 Percentage Change
Standard Error 35.009
|
16.72 Percentage Change
Standard Error 17.806
|
19.22 Percentage Change
Standard Error 9.802
|
23.93 Percentage Change
Standard Error 11.289
|
—
|
|
Change From Baseline in Thigh Muscle Maximal Cross Sectional Area (CSAmax) in the Double-Blind Phase
W24: SARTORIUS
|
10.75 Percentage Change
Standard Error 7.136
|
0.81 Percentage Change
Standard Error 8.143
|
-14.18 Percentage Change
Standard Error 9.481
|
16.63 Percentage Change
Standard Error 4.476
|
25.51 Percentage Change
Standard Error 6.404
|
—
|
|
Change From Baseline in Thigh Muscle Maximal Cross Sectional Area (CSAmax) in the Double-Blind Phase
W24: SEMIMEMBRANOSUS
|
45.83 Percentage Change
Standard Error 14.896
|
30.01 Percentage Change
Standard Error 18.631
|
-11.48 Percentage Change
Standard Error 24.468
|
61.03 Percentage Change
Standard Error 25.524
|
49.49 Percentage Change
Standard Error 12.011
|
—
|
SECONDARY outcome
Timeframe: Day 8 through Week 228, baseline and on-study information represented in table.Population: The safety population included all participants who received at least one dose of study drug. The Whole Study set reported here includes data from RO7239361-treated participants only.
A positive ADA sample is defined as one in which the presence of detectable ADAs is confirmed to be specific to RO7239361. A participant is considered as ADA positive if, after initiation of treatment, they have an ADA positive relative to baseline sample. Double-blind phase data for placebo participants are not included in this Whole Study outcome measure, but are reported in the outcome measure specific to the double-blind period. At the end of the double-blind period participants in the placebo arm switched to one of the RO7239361 arms upon entering the open label phase. Participants in Panel 1 received 4 mg RO7239361; participants in Panel 2 received either 12.5 mg (weight between 15 and 45 kg) or 20 mg (weight \>45 kg) RO7239361, and participants in Panel 3 and the Expansion Panel received either 35 mg (weight between 15 and 45 kg) or 50 mg (weight \>45 kg) RO7239361.
Outcome measures
| Measure |
Placebo
n=9 Participants
Placebo subcutaneous injections on specified days
|
Panel 1 RO7239361
n=8 Participants
RO7239361 subcutaneous injections on specified days. The Panel 1 dose targets achievement of \> 50% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. The Panel 1 body weight tier dose is \>15kg at a dose of 4 mg (milligram) /0.8 mL (millilitre).
|
Panel 2 RO7239361
n=26 Participants
RO7239361 subcutaneous injections on specified days. The Panel 2 dose targets achievement of \> 85% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 2 body weight tier doses are =\>15kg to =\< 45kg at a dose of 12.5 mg /0.25 mL and =\>45kg at a dose of 20 mg /0.4 mL
|
Panel 3 and Expansion RO7239361
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of \> 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =\>15kg to =\< 45kg at a dose of 35 mg /0.7 mL and =\>45kg at a dose of 50 mg /1.0 mL
|
Expansion Panel RO7239361 35mg
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of \> 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =\>15kg to =\< 45kg at a dose of 35 mg /0.7 mL and =\>45kg at a dose of 50 mg /1.0 mL
|
Expansion Panel RO7239361 50mg
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of \> 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =\>15kg to =\< 45kg at a dose of 35 mg /0.7 mL and =\>45kg at a dose of 50 mg /1.0 mL
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Positive Anti-RO7239361 Antibodies (ADA) Assessment, Whole Study
Baseline (BL): ADA Positive
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Positive Anti-RO7239361 Antibodies (ADA) Assessment, Whole Study
BL: ADA Negative
|
100.0 percentage of participants
|
87.5 percentage of participants
|
92.3 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Positive Anti-RO7239361 Antibodies (ADA) Assessment, Whole Study
On-treatment: Persistent Positive
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Positive Anti-RO7239361 Antibodies (ADA) Assessment, Whole Study
On-treatment: Missing
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Positive Anti-RO7239361 Antibodies (ADA) Assessment, Whole Study
BL: Missing
|
0 percentage of participants
|
12.5 percentage of participants
|
7.7 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Positive Anti-RO7239361 Antibodies (ADA) Assessment, Whole Study
On-treatment: ADA Positive
|
0 percentage of participants
|
0 percentage of participants
|
3.8 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Positive Anti-RO7239361 Antibodies (ADA) Assessment, Whole Study
On-treatment: Only last sample Positive
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Positive Anti-RO7239361 Antibodies (ADA) Assessment, Whole Study
On-treatment: Other Positive
|
0 percentage of participants
|
0 percentage of participants
|
3.8 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Positive Anti-RO7239361 Antibodies (ADA) Assessment, Whole Study
On-treatment: ADA Negative
|
100.0 percentage of participants
|
100.0 percentage of participants
|
96.2 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Positive Anti-RO7239361 Antibodies (ADA) Assessment, Whole Study
On-treatment: ADA Negative, BL Positive, No Boost
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline through Week 252Population: The pharmacodynamics (PD) data set included all available data from subjects for whom PD measurements were available at baseline and at least one other timepoint. The Whole Study set reported here includes data from RO7239361-treated participants only.
Double-blind phase data for placebo participants are not included in this Whole Study outcome measure, but are reported in the outcome measure specific to the double-blind period. At the end of the double-blind period participants in the placebo arm switched to one of the RO7239361 arms upon entering the open label phase. Participants in Panel 1 received 4 mg RO7239361; participants in Panel 2 received either 12.5 mg (weight between 15 and 45 kg) or 20 mg (weight \>45 kg) RO7239361, and participants in Panel 3 and the Expansion Panel received either 35 mg (weight between 15 and 45 kg) or 50 mg (weight \>45 kg) RO7239361.
Outcome measures
| Measure |
Placebo
n=9 Participants
Placebo subcutaneous injections on specified days
|
Panel 1 RO7239361
n=8 Participants
RO7239361 subcutaneous injections on specified days. The Panel 1 dose targets achievement of \> 50% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. The Panel 1 body weight tier dose is \>15kg at a dose of 4 mg (milligram) /0.8 mL (millilitre).
|
Panel 2 RO7239361
n=25 Participants
RO7239361 subcutaneous injections on specified days. The Panel 2 dose targets achievement of \> 85% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 2 body weight tier doses are =\>15kg to =\< 45kg at a dose of 12.5 mg /0.25 mL and =\>45kg at a dose of 20 mg /0.4 mL
|
Panel 3 and Expansion RO7239361
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of \> 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =\>15kg to =\< 45kg at a dose of 35 mg /0.7 mL and =\>45kg at a dose of 50 mg /1.0 mL
|
Expansion Panel RO7239361 35mg
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of \> 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =\>15kg to =\< 45kg at a dose of 35 mg /0.7 mL and =\>45kg at a dose of 50 mg /1.0 mL
|
Expansion Panel RO7239361 50mg
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of \> 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =\>15kg to =\< 45kg at a dose of 35 mg /0.7 mL and =\>45kg at a dose of 50 mg /1.0 mL
|
|---|---|---|---|---|---|---|
|
Serum Concentration of Free Myostatin, Whole Study
Baseline
|
986.8 pg/mL
Standard Deviation 363.69
|
1358.4 pg/mL
Standard Deviation 964.47
|
1159.3 pg/mL
Standard Deviation 601.29
|
—
|
—
|
—
|
|
Serum Concentration of Free Myostatin, Whole Study
Day 22
|
382.4 pg/mL
Standard Deviation 82.58
|
284.8 pg/mL
Standard Deviation 324.16
|
35.3 pg/mL
Standard Deviation 51.45
|
—
|
—
|
—
|
|
Serum Concentration of Free Myostatin, Whole Study
Day 29
|
372.3 pg/mL
Standard Deviation 79.97
|
179.0 pg/mL
Standard Deviation 137.39
|
24.8 pg/mL
Standard Deviation 27.24
|
—
|
—
|
—
|
|
Serum Concentration of Free Myostatin, Whole Study
Week 24
|
357.9 pg/mL
Standard Deviation 137.56
|
139.1 pg/mL
Standard Deviation 111.63
|
23.0 pg/mL
Standard Deviation 23.68
|
—
|
—
|
—
|
|
Serum Concentration of Free Myostatin, Whole Study
Week 60
|
284.6 pg/mL
Standard Deviation 96.92
|
90.4 pg/mL
Standard Deviation 39.30
|
36.3 pg/mL
Standard Deviation 54.13
|
—
|
—
|
—
|
|
Serum Concentration of Free Myostatin, Whole Study
Week 108
|
320.9 pg/mL
Standard Deviation 222.10
|
84.4 pg/mL
Standard Deviation 61.19
|
40.2 pg/mL
Standard Deviation 42.70
|
—
|
—
|
—
|
|
Serum Concentration of Free Myostatin, Whole Study
Week 132
|
283.5 pg/mL
Standard Deviation 103.73
|
71.0 pg/mL
Standard Deviation 40.02
|
40.2 pg/mL
Standard Deviation 38.26
|
—
|
—
|
—
|
|
Serum Concentration of Free Myostatin, Whole Study
Day 4
|
421.4 pg/mL
Standard Deviation 70.60
|
321.3 pg/mL
Standard Deviation 165.91
|
58.3 pg/mL
Standard Deviation 33.20
|
—
|
—
|
—
|
|
Serum Concentration of Free Myostatin, Whole Study
Day 5
|
446.6 pg/mL
Standard Deviation 108.81
|
357.8 pg/mL
Standard Deviation 166.27
|
66.1 pg/mL
Standard Deviation 39.07
|
—
|
—
|
—
|
|
Serum Concentration of Free Myostatin, Whole Study
Day 8
|
522.7 pg/mL
Standard Deviation 131.51
|
479.2 pg/mL
Standard Deviation 319.13
|
206.8 pg/mL
Standard Deviation 419.21
|
—
|
—
|
—
|
|
Serum Concentration of Free Myostatin, Whole Study
Day 15
|
478.4 pg/mL
Standard Deviation 111.44
|
280.8 pg/mL
Standard Deviation 148.53
|
54.8 pg/mL
Standard Deviation 61.85
|
—
|
—
|
—
|
|
Serum Concentration of Free Myostatin, Whole Study
Day 33
|
291.1 pg/mL
Standard Deviation 77.55
|
115.7 pg/mL
Standard Deviation 84.49
|
24.3 pg/mL
Standard Deviation 30.64
|
—
|
—
|
—
|
|
Serum Concentration of Free Myostatin, Whole Study
Week 12
|
394.0 pg/mL
Standard Deviation 179.78
|
115.0 pg/mL
Standard Deviation 62.23
|
18.1 pg/mL
Standard Deviation 13.37
|
—
|
—
|
—
|
|
Serum Concentration of Free Myostatin, Whole Study
Week 25
|
331.0 pg/mL
Standard Deviation 116.78
|
154.5 pg/mL
Standard Deviation 115.21
|
22.8 pg/mL
Standard Deviation 18.48
|
—
|
—
|
—
|
|
Serum Concentration of Free Myostatin, Whole Study
Week 36
|
340.3 pg/mL
Standard Deviation 98.24
|
81.4 pg/mL
Standard Deviation 36.00
|
21.1 pg/mL
Standard Deviation 22.03
|
—
|
—
|
—
|
|
Serum Concentration of Free Myostatin, Whole Study
Week 48
|
401.3 pg/mL
Standard Deviation 233.76
|
79.0 pg/mL
Standard Deviation 37.85
|
18.6 pg/mL
Standard Deviation 12.11
|
—
|
—
|
—
|
|
Serum Concentration of Free Myostatin, Whole Study
Week 72
|
326.8 pg/mL
Standard Deviation 151.29
|
132.0 pg/mL
Standard Deviation 146.37
|
205.7 pg/mL
Standard Deviation 321.58
|
—
|
—
|
—
|
|
Serum Concentration of Free Myostatin, Whole Study
Week 84
|
534.0 pg/mL
Standard Deviation 260.31
|
74.2 pg/mL
Standard Deviation 13.58
|
115.6 pg/mL
Standard Deviation 146.44
|
—
|
—
|
—
|
|
Serum Concentration of Free Myostatin, Whole Study
Week 144
|
—
|
95.2 pg/mL
Standard Deviation NA
NA: SD not calculable for 1 participant
|
—
|
—
|
—
|
—
|
|
Serum Concentration of Free Myostatin, Whole Study
Week 156
|
208.7 pg/mL
Standard Deviation 64.52
|
48.9 pg/mL
Standard Deviation 22.42
|
20.0 pg/mL
Standard Deviation 0.00
|
—
|
—
|
—
|
|
Serum Concentration of Free Myostatin, Whole Study
Week 180
|
212.5 pg/mL
Standard Deviation 146.37
|
—
|
—
|
—
|
—
|
—
|
|
Serum Concentration of Free Myostatin, Whole Study
Week 252
|
—
|
20.0 pg/mL
Standard Deviation NA
NA: SD not calculable for 1 participant
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline through Week 252Population: The pharmacodynamics (PD) data set included all available data from subjects for whom PD measurements were available at baseline and at least one other timepoint. The Whole Study set reported here includes data from RO7239361-treated participants only.
Double-blind phase data for placebo participants are not included in this Whole Study outcome measure, but are reported in the outcome measure specific to the double-blind period. At the end of the double-blind period participants in the placebo arm switched to one of the RO7239361 arms upon entering the open label phase. Participants in Panel 1 received 4 mg RO7239361; participants in Panel 2 received either 12.5 mg (weight between 15 and 45 kg) or 20 mg (weight \>45 kg) RO7239361, and participants in Panel 3 and the Expansion Panel received either 35 mg (weight between 15 and 45 kg) or 50 mg (weight \>45 kg) RO7239361.
Outcome measures
| Measure |
Placebo
n=8 Participants
Placebo subcutaneous injections on specified days
|
Panel 1 RO7239361
n=8 Participants
RO7239361 subcutaneous injections on specified days. The Panel 1 dose targets achievement of \> 50% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. The Panel 1 body weight tier dose is \>15kg at a dose of 4 mg (milligram) /0.8 mL (millilitre).
|
Panel 2 RO7239361
n=22 Participants
RO7239361 subcutaneous injections on specified days. The Panel 2 dose targets achievement of \> 85% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 2 body weight tier doses are =\>15kg to =\< 45kg at a dose of 12.5 mg /0.25 mL and =\>45kg at a dose of 20 mg /0.4 mL
|
Panel 3 and Expansion RO7239361
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of \> 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =\>15kg to =\< 45kg at a dose of 35 mg /0.7 mL and =\>45kg at a dose of 50 mg /1.0 mL
|
Expansion Panel RO7239361 35mg
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of \> 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =\>15kg to =\< 45kg at a dose of 35 mg /0.7 mL and =\>45kg at a dose of 50 mg /1.0 mL
|
Expansion Panel RO7239361 50mg
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of \> 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =\>15kg to =\< 45kg at a dose of 35 mg /0.7 mL and =\>45kg at a dose of 50 mg /1.0 mL
|
|---|---|---|---|---|---|---|
|
Percent Inhibition of Free Myostatin, Whole Study
Day 4
|
49.689 percentage inhibition
Standard Deviation 11.7394
|
73.533 percentage inhibition
Standard Deviation 9.8637
|
95.334 percentage inhibition
Standard Deviation 2.4477
|
—
|
—
|
—
|
|
Percent Inhibition of Free Myostatin, Whole Study
Day 5
|
46.506 percentage inhibition
Standard Deviation 9.0917
|
69.700 percentage inhibition
Standard Deviation 10.3411
|
94.545 percentage inhibition
Standard Deviation 2.7608
|
—
|
—
|
—
|
|
Percent Inhibition of Free Myostatin, Whole Study
Day 15
|
40.763 percentage inhibition
Standard Deviation 10.0071
|
77.090 percentage inhibition
Standard Deviation 6.2939
|
96.488 percentage inhibition
Standard Deviation 1.9665
|
—
|
—
|
—
|
|
Percent Inhibition of Free Myostatin, Whole Study
Day 29
|
52.926 percentage inhibition
Standard Deviation 6.6001
|
86.894 percentage inhibition
Standard Deviation 2.9590
|
98.202 percentage inhibition
Standard Deviation 1.4590
|
—
|
—
|
—
|
|
Percent Inhibition of Free Myostatin, Whole Study
Day 33
|
61.796 percentage inhibition
Standard Deviation 4.5760
|
91.557 percentage inhibition
Standard Deviation 2.6444
|
97.042 percentage inhibition
Standard Deviation 5.4443
|
—
|
—
|
—
|
|
Percent Inhibition of Free Myostatin, Whole Study
Week 36
|
64.103 percentage inhibition
Standard Deviation 5.3774
|
92.057 percentage inhibition
Standard Deviation 2.6300
|
98.470 percentage inhibition
Standard Deviation 0.8410
|
—
|
—
|
—
|
|
Percent Inhibition of Free Myostatin, Whole Study
Week 72
|
65.956 percentage inhibition
Standard Deviation 8.2066
|
92.536 percentage inhibition
Standard Deviation 2.4445
|
79.193 percentage inhibition
Standard Deviation 31.9504
|
—
|
—
|
—
|
|
Percent Inhibition of Free Myostatin, Whole Study
Week 84
|
54.990 percentage inhibition
Standard Deviation 11.0397
|
92.328 percentage inhibition
Standard Deviation 5.7945
|
89.744 percentage inhibition
Standard Deviation 13.0990
|
—
|
—
|
—
|
|
Percent Inhibition of Free Myostatin, Whole Study
Week 132
|
71.129 percentage inhibition
Standard Deviation 4.9576
|
92.935 percentage inhibition
Standard Deviation 3.8121
|
96.713 percentage inhibition
Standard Deviation 2.4278
|
—
|
—
|
—
|
|
Percent Inhibition of Free Myostatin, Whole Study
Day 8
|
38.411 percentage inhibition
Standard Deviation 7.0320
|
62.524 percentage inhibition
Standard Deviation 9.7074
|
84.797 percentage inhibition
Standard Deviation 22.1958
|
—
|
—
|
—
|
|
Percent Inhibition of Free Myostatin, Whole Study
Day 22
|
51.836 percentage inhibition
Standard Deviation 9.3488
|
81.693 percentage inhibition
Standard Deviation 5.7392
|
97.927 percentage inhibition
Standard Deviation 1.1259
|
—
|
—
|
—
|
|
Percent Inhibition of Free Myostatin, Whole Study
Week 12
|
58.934 percentage inhibition
Standard Deviation 8.7345
|
92.025 percentage inhibition
Standard Deviation 2.0548
|
98.208 percentage inhibition
Standard Deviation 1.5605
|
—
|
—
|
—
|
|
Percent Inhibition of Free Myostatin, Whole Study
Week 24
|
63.199 percentage inhibition
Standard Deviation 5.3419
|
89.664 percentage inhibition
Standard Deviation 5.0245
|
98.009 percentage inhibition
Standard Deviation 1.8677
|
—
|
—
|
—
|
|
Percent Inhibition of Free Myostatin, Whole Study
Week 25
|
62.446 percentage inhibition
Standard Deviation 7.0668
|
88.689 percentage inhibition
Standard Deviation 4.8868
|
97.974 percentage inhibition
Standard Deviation 1.8259
|
—
|
—
|
—
|
|
Percent Inhibition of Free Myostatin, Whole Study
Week 48
|
58.161 percentage inhibition
Standard Deviation 15.7101
|
92.237 percentage inhibition
Standard Deviation 3.4952
|
98.036 percentage inhibition
Standard Deviation 1.4516
|
—
|
—
|
—
|
|
Percent Inhibition of Free Myostatin, Whole Study
Week 60
|
66.280 percentage inhibition
Standard Deviation 8.4684
|
90.974 percentage inhibition
Standard Deviation 2.1780
|
97.177 percentage inhibition
Standard Deviation 2.8783
|
—
|
—
|
—
|
|
Percent Inhibition of Free Myostatin, Whole Study
Week 108
|
70.498 percentage inhibition
Standard Deviation 15.2905
|
92.412 percentage inhibition
Standard Deviation 3.3662
|
95.884 percentage inhibition
Standard Deviation 3.5214
|
—
|
—
|
—
|
|
Percent Inhibition of Free Myostatin, Whole Study
Week 144
|
—
|
94.732 percentage inhibition
Standard Deviation NA
NA: SD not calculable for 1 participant
|
—
|
—
|
—
|
—
|
|
Percent Inhibition of Free Myostatin, Whole Study
Week 156
|
74.712 percentage inhibition
Standard Deviation 5.7764
|
94.881 percentage inhibition
Standard Deviation 1.3726
|
98.183 percentage inhibition
Standard Deviation 0.8086
|
—
|
—
|
—
|
|
Percent Inhibition of Free Myostatin, Whole Study
Week 180
|
75.374 percentage inhibition
Standard Deviation 9.5968
|
—
|
—
|
—
|
—
|
—
|
|
Percent Inhibition of Free Myostatin, Whole Study
Week 252
|
—
|
96.283 percentage inhibition
Standard Deviation NA
NA: SD not calculable for 1 participant
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline through Week 252Population: The pharmacodynamics (PD) data set included all available data from subjects for whom PD measurements were available at baseline and at least one other timepoint. Data are analyzed according to the arms in which participants started the study.
Participants in the Placebo arm received placebo during the double-blind (DB) period (up to Week 24) and received RO7239361 during the open label (OL) phase. PFS in table row title indicates when study drug was changed from vial to prefilled syringe (PFS). Participants in Panel 1 received 4 mg RO7239361; participants in Panel 2 received either 12.5 mg (weight between 15 and 45 kg) or 20 mg (weight \>45 kg) RO7239361, and participants in Panel 3 and the Expansion Panel received either 35 mg (weight between 15 and 45 kg) or 50 mg (weight \>45 kg) RO7239361.
Outcome measures
| Measure |
Placebo
n=11 Participants
Placebo subcutaneous injections on specified days
|
Panel 1 RO7239361
n=7 Participants
RO7239361 subcutaneous injections on specified days. The Panel 1 dose targets achievement of \> 50% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. The Panel 1 body weight tier dose is \>15kg at a dose of 4 mg (milligram) /0.8 mL (millilitre).
|
Panel 2 RO7239361
n=6 Participants
RO7239361 subcutaneous injections on specified days. The Panel 2 dose targets achievement of \> 85% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 2 body weight tier doses are =\>15kg to =\< 45kg at a dose of 12.5 mg /0.25 mL and =\>45kg at a dose of 20 mg /0.4 mL
|
Panel 3 and Expansion RO7239361
n=19 Participants
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of \> 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =\>15kg to =\< 45kg at a dose of 35 mg /0.7 mL and =\>45kg at a dose of 50 mg /1.0 mL
|
Expansion Panel RO7239361 35mg
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of \> 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =\>15kg to =\< 45kg at a dose of 35 mg /0.7 mL and =\>45kg at a dose of 50 mg /1.0 mL
|
Expansion Panel RO7239361 50mg
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of \> 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =\>15kg to =\< 45kg at a dose of 35 mg /0.7 mL and =\>45kg at a dose of 50 mg /1.0 mL
|
|---|---|---|---|---|---|---|
|
Serum Concentration of Drug-Myostatin Complex, Whole Study
Day 4
|
1.178 ng/mL
Standard Deviation 1.8833
|
5.070 ng/mL
Standard Deviation 0.9456
|
12.606 ng/mL
Standard Deviation 5.7623
|
14.696 ng/mL
Standard Deviation 5.7926
|
—
|
—
|
|
Serum Concentration of Drug-Myostatin Complex, Whole Study
Day 5
|
2.119 ng/mL
Standard Deviation 2.9826
|
5.845 ng/mL
Standard Deviation 2.5725
|
14.856 ng/mL
Standard Deviation 7.6131
|
17.308 ng/mL
Standard Deviation 7.5955
|
—
|
—
|
|
Serum Concentration of Drug-Myostatin Complex, Whole Study
Day 8
|
4.924 ng/mL
Standard Deviation 12.9975
|
7.041 ng/mL
Standard Deviation 2.3470
|
19.906 ng/mL
Standard Deviation 9.8664
|
21.609 ng/mL
Standard Deviation 11.0880
|
—
|
—
|
|
Serum Concentration of Drug-Myostatin Complex, Whole Study
Day 22
|
1.326 ng/mL
Standard Deviation 1.3410
|
11.985 ng/mL
Standard Deviation 4.8243
|
36.811 ng/mL
Standard Deviation 26.8560
|
52.841 ng/mL
Standard Deviation 21.5542
|
—
|
—
|
|
Serum Concentration of Drug-Myostatin Complex, Whole Study
Day 33
|
1.157 ng/mL
Standard Deviation 1.0036
|
18.542 ng/mL
Standard Deviation 3.9874
|
46.279 ng/mL
Standard Deviation 24.1457
|
77.142 ng/mL
Standard Deviation 32.4153
|
—
|
—
|
|
Serum Concentration of Drug-Myostatin Complex, Whole Study
Week 12
|
7.082 ng/mL
Standard Deviation 15.2289
|
28.556 ng/mL
Standard Deviation 22.7890
|
79.555 ng/mL
Standard Deviation 17.2126
|
88.402 ng/mL
Standard Deviation 29.8080
|
—
|
—
|
|
Serum Concentration of Drug-Myostatin Complex, Whole Study
Week 24 (end of DB period)
|
3.589 ng/mL
Standard Deviation 7.8108
|
25.997 ng/mL
Standard Deviation 6.4384
|
83.262 ng/mL
Standard Deviation 64.2281
|
101.406 ng/mL
Standard Deviation 45.4197
|
—
|
—
|
|
Serum Concentration of Drug-Myostatin Complex, Whole Study
Week 25 (Week 1 OL)
|
3.186 ng/mL
Standard Deviation 6.9734
|
31.963 ng/mL
Standard Deviation 8.0240
|
77.926 ng/mL
Standard Deviation 56.9987
|
102.211 ng/mL
Standard Deviation 40.2284
|
—
|
—
|
|
Serum Concentration of Drug-Myostatin Complex, Whole Study
Week 36 (Week 12 OL)
|
95.788 ng/mL
Standard Deviation 88.1521
|
22.584 ng/mL
Standard Deviation 8.6839
|
57.164 ng/mL
Standard Deviation 25.8284
|
101.234 ng/mL
Standard Deviation 42.0902
|
—
|
—
|
|
Serum Concentration of Drug-Myostatin Complex, Whole Study
Week 132 (Week 108 OL)
|
95.811 ng/mL
Standard Deviation 48.1440
|
32.133 ng/mL
Standard Deviation 8.2848
|
75.040 ng/mL
Standard Deviation 14.3015
|
107.378 ng/mL
Standard Deviation 37.8814
|
—
|
—
|
|
Serum Concentration of Drug-Myostatin Complex, Whole Study
Week 156 (Week 132 OL: Week 12 PFS)
|
152.000 ng/mL
Standard Deviation NA
NA: SD not calculable for 1 participant
|
—
|
—
|
125.583 ng/mL
Standard Deviation 44.4144
|
—
|
—
|
|
Serum Concentration of Drug-Myostatin Complex, Whole Study
Week 168 (Week 144 OL: Day 1 PFS)
|
105.700 ng/mL
Standard Deviation 54.5772
|
—
|
70.100 ng/mL
Standard Deviation 25.1213
|
122.633 ng/mL
Standard Deviation 91.2542
|
—
|
—
|
|
Serum Concentration of Drug-Myostatin Complex, Whole Study
Week 168 (Week 144 OL: Day 8 PFS)
|
—
|
—
|
—
|
119.000 ng/mL
Standard Deviation NA
NA: SD not calculable for 1 participant
|
—
|
—
|
|
Serum Concentration of Drug-Myostatin Complex, Whole Study
Week 192 (Week 168 OL: Day 1 PFS)
|
—
|
18.000 ng/mL
Standard Deviation NA
NA: SD not calculable for 1 participant
|
—
|
—
|
—
|
—
|
|
Serum Concentration of Drug-Myostatin Complex, Whole Study
Week 192 (Week 168 OL: Day 45 PFS)
|
—
|
80.400 ng/mL
Standard Deviation NA
NA: SD not calculable for 1 participant
|
—
|
—
|
—
|
—
|
|
Serum Concentration of Drug-Myostatin Complex, Whole Study
Week 252 (Week 228 OL)
|
96.770 ng/mL
Standard Deviation 61.6084
|
52.680 ng/mL
Standard Deviation 20.8619
|
87.900 ng/mL
Standard Deviation 38.5763
|
106.071 ng/mL
Standard Deviation 48.6434
|
—
|
—
|
|
Serum Concentration of Drug-Myostatin Complex, Whole Study
Day 15
|
0.613 ng/mL
Standard Deviation 0.2102
|
14.067 ng/mL
Standard Deviation 7.1096
|
29.229 ng/mL
Standard Deviation 10.4929
|
45.289 ng/mL
Standard Deviation 18.7600
|
—
|
—
|
|
Serum Concentration of Drug-Myostatin Complex, Whole Study
Day 29
|
1.593 ng/mL
Standard Deviation 3.1007
|
15.735 ng/mL
Standard Deviation 4.2010
|
43.236 ng/mL
Standard Deviation 34.0300
|
67.255 ng/mL
Standard Deviation 27.9376
|
—
|
—
|
|
Serum Concentration of Drug-Myostatin Complex, Whole Study
Week 48 (Week 24 OL)
|
90.593 ng/mL
Standard Deviation 73.7102
|
27.461 ng/mL
Standard Deviation 7.2306
|
—
|
103.657 ng/mL
Standard Deviation 45.8802
|
—
|
—
|
|
Serum Concentration of Drug-Myostatin Complex, Whole Study
Week 60 (Week 36 OL)
|
63.358 ng/mL
Standard Deviation 37.5591
|
41.779 ng/mL
Standard Deviation 34.2407
|
89.712 ng/mL
Standard Deviation 38.9214
|
67.163 ng/mL
Standard Deviation 8.4904
|
—
|
—
|
|
Serum Concentration of Drug-Myostatin Complex, Whole Study
Week 72 (Week 48 OL)
|
92.086 ng/mL
Standard Deviation 68.5222
|
26.740 ng/mL
Standard Deviation 3.0256
|
0.550 ng/mL
Standard Deviation NA
NA: SD not calculable for 1 participant
|
102.025 ng/mL
Standard Deviation 31.4717
|
—
|
—
|
|
Serum Concentration of Drug-Myostatin Complex, Whole Study
Week 84 (Week 60 OL)
|
146.950 ng/mL
Standard Deviation 131.3706
|
27.110 ng/mL
Standard Deviation 3.2527
|
—
|
117.719 ng/mL
Standard Deviation 41.1143
|
—
|
—
|
|
Serum Concentration of Drug-Myostatin Complex, Whole Study
Week 108 (Week 84 OL)
|
122.610 ng/mL
Standard Deviation 87.1911
|
36.014 ng/mL
Standard Deviation 10.9338
|
66.020 ng/mL
Standard Deviation 7.2878
|
114.806 ng/mL
Standard Deviation 32.7432
|
—
|
—
|
|
Serum Concentration of Drug-Myostatin Complex, Whole Study
Week 144 (Week 120 OL)
|
—
|
25.600 ng/mL
Standard Deviation NA
NA: SD not calculable for 1 participant
|
—
|
—
|
—
|
—
|
|
Serum Concentration of Drug-Myostatin Complex, Whole Study
Week 156 (Week 132 OL)
|
95.529 ng/mL
Standard Deviation 48.0065
|
30.186 ng/mL
Standard Deviation 7.0053
|
69.325 ng/mL
Standard Deviation 17.7064
|
108.100 ng/mL
Standard Deviation 35.5833
|
—
|
—
|
|
Serum Concentration of Drug-Myostatin Complex, Whole Study
Week 156 (Week 132 OL: Day 1 PFS)
|
64.400 ng/mL
Standard Deviation 0.5657
|
—
|
—
|
—
|
—
|
—
|
|
Serum Concentration of Drug-Myostatin Complex, Whole Study
Week 168 (Week 144 OL: Week 12 PFS)
|
—
|
—
|
94.900 ng/mL
Standard Deviation NA
NA: SD not calculable for 1 participant
|
—
|
—
|
—
|
|
Serum Concentration of Drug-Myostatin Complex, Whole Study
Week 180 (Week 156 OL)
|
45.933 ng/mL
Standard Deviation 28.3161
|
25.589 ng/mL
Standard Deviation 12.2478
|
103.300 ng/mL
Standard Deviation 16.5463
|
—
|
—
|
—
|
|
Serum Concentration of Drug-Myostatin Complex, Whole Study
Week 180 (Week 156 OL: Week 12 PFS)
|
—
|
62.600 ng/mL
Standard Deviation NA
NA: SD not calculable for 1 participant
|
—
|
—
|
—
|
—
|
Adverse Events
Placebo Double-Blind
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Panel 1 RO7239361 Double-Blind
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Panel 2 RO7239361 Double-Blind
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Panel 3 and Expansion Panel RO7239361 Double-Blind
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
Panel 1 RO7239361 Open-Label
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Panel 2 RO7239361 Open-Label
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Panel 3 and Expansion Panel RO7239361 Open-Label
Serious events: 1 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo Double-Blind
n=11 participants at risk
Placebo subcutaneous injections on specified days during the double-blind period.
|
Panel 1 RO7239361 Double-Blind
n=7 participants at risk
RO7239361 subcutaneous injections on specified days during the double-blind period.
|
Panel 2 RO7239361 Double-Blind
n=6 participants at risk
RO7239361 subcutaneous injections on specified days during the double-blind period.
|
Panel 3 and Expansion Panel RO7239361 Double-Blind
n=19 participants at risk
RO7239361 subcutaneous injections on specified days during the double-blind period.
|
Panel 1 RO7239361 Open-Label
n=9 participants at risk
RO7239361 subcutaneous injections on specified days during the open-label period.
|
Panel 2 RO7239361 Open-Label
n=8 participants at risk
RO7239361 subcutaneous injections on specified days during the open label period.
|
Panel 3 and Expansion Panel RO7239361 Open-Label
n=26 participants at risk
RO7239361 subcutaneous injections on specified days during the open-label period.
|
|---|---|---|---|---|---|---|---|
|
Infections and infestations
APPENDICITIS PERFORATED
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
11.1%
1/9 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/26 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Infections and infestations
INFLUENZA
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
12.5%
1/8 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/26 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Injury, poisoning and procedural complications
FEMUR FRACTURE
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
3.8%
1/26 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Injury, poisoning and procedural complications
SKULL FRACTURE
|
9.1%
1/11 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/26 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Injury, poisoning and procedural complications
SPINAL COMPRESSION FRACTURE
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
5.3%
1/19 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/26 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Musculoskeletal and connective tissue disorders
RHABDOMYOLYSIS
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
12.5%
1/8 • Number of events 2 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/26 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Psychiatric disorders
CONVERSION DISORDER
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
12.5%
1/8 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/26 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
Other adverse events
| Measure |
Placebo Double-Blind
n=11 participants at risk
Placebo subcutaneous injections on specified days during the double-blind period.
|
Panel 1 RO7239361 Double-Blind
n=7 participants at risk
RO7239361 subcutaneous injections on specified days during the double-blind period.
|
Panel 2 RO7239361 Double-Blind
n=6 participants at risk
RO7239361 subcutaneous injections on specified days during the double-blind period.
|
Panel 3 and Expansion Panel RO7239361 Double-Blind
n=19 participants at risk
RO7239361 subcutaneous injections on specified days during the double-blind period.
|
Panel 1 RO7239361 Open-Label
n=9 participants at risk
RO7239361 subcutaneous injections on specified days during the open-label period.
|
Panel 2 RO7239361 Open-Label
n=8 participants at risk
RO7239361 subcutaneous injections on specified days during the open label period.
|
Panel 3 and Expansion Panel RO7239361 Open-Label
n=26 participants at risk
RO7239361 subcutaneous injections on specified days during the open-label period.
|
|---|---|---|---|---|---|---|---|
|
General disorders
INJECTION SITE REACTION
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
22.2%
2/9 • Number of events 2 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/26 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
General disorders
INJECTION SITE SWELLING
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
5.3%
1/19 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/26 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Cardiac disorders
CARDIOMYOPATHY
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
11.1%
1/9 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/26 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Cardiac disorders
LEFT VENTRICULAR DYSFUNCTION
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
11.1%
1/9 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/26 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Cardiac disorders
MYOCARDIAL FIBROSIS
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
11.1%
1/9 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/26 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Cardiac disorders
SINUS TACHYCARDIA
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
5.3%
1/19 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/26 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Congenital, familial and genetic disorders
DERMOID CYST
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
5.3%
1/19 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/26 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Ear and labyrinth disorders
EAR PAIN
|
9.1%
1/11 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
3.8%
1/26 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Ear and labyrinth disorders
TYMPANIC MEMBRANE HYPERAEMIA
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
3.8%
1/26 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Ear and labyrinth disorders
TYMPANIC MEMBRANE PERFORATION
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
16.7%
1/6 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/26 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Endocrine disorders
ADRENAL INSUFFICIENCY
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
3.8%
1/26 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Endocrine disorders
CUSHINGOID
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
7.7%
2/26 • Number of events 2 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Endocrine disorders
DELAYED PUBERTY
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
11.1%
1/9 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/26 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Eye disorders
CATARACT
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
3.8%
1/26 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Eye disorders
DRY EYE
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
3.8%
1/26 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Eye disorders
VISION BLURRED
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
11.1%
1/9 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/26 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
9.1%
1/11 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/26 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
9.1%
1/11 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
5.3%
1/19 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
11.1%
1/9 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
3.8%
1/26 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN LOWER
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
3.8%
1/26 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
9.1%
1/11 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
14.3%
1/7 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
10.5%
2/19 • Number of events 2 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
11.1%
1/9 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
11.5%
3/26 • Number of events 11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Gastrointestinal disorders
BREATH ODOUR
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
5.3%
1/19 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/26 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Gastrointestinal disorders
CONSTIPATION
|
9.1%
1/11 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/26 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Gastrointestinal disorders
DIARRHOEA
|
18.2%
2/11 • Number of events 4 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
14.3%
1/7 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
16.7%
1/6 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
10.5%
2/19 • Number of events 2 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
11.1%
1/9 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
12.5%
1/8 • Number of events 3 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
34.6%
9/26 • Number of events 14 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Gastrointestinal disorders
DYSPEPSIA
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
16.7%
1/6 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
3.8%
1/26 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Gastrointestinal disorders
GASTRIC ULCER
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
12.5%
1/8 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/26 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Gastrointestinal disorders
HAEMATOCHEZIA
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
3.8%
1/26 • Number of events 3 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Gastrointestinal disorders
LIP SWELLING
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
16.7%
1/6 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/26 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Gastrointestinal disorders
MALPOSITIONED TEETH
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
3.8%
1/26 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Gastrointestinal disorders
MOUTH ULCERATION
|
9.1%
1/11 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/26 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Gastrointestinal disorders
MUCOUS STOOLS
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
3.8%
1/26 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Gastrointestinal disorders
NAUSEA
|
9.1%
1/11 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
11.1%
1/9 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
11.5%
3/26 • Number of events 3 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Gastrointestinal disorders
RECTAL HAEMORRHAGE
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
3.8%
1/26 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Gastrointestinal disorders
VOMITING
|
9.1%
1/11 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
14.3%
1/7 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
21.1%
4/19 • Number of events 4 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
44.4%
4/9 • Number of events 11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
12.5%
1/8 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
30.8%
8/26 • Number of events 9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
General disorders
CHILLS
|
9.1%
1/11 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/26 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
General disorders
FATIGUE
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
5.3%
1/19 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
3.8%
1/26 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
3.8%
1/26 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
General disorders
INJECTION SITE BRUISING
|
9.1%
1/11 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
33.3%
2/6 • Number of events 2 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
15.8%
3/19 • Number of events 3 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
22.2%
2/9 • Number of events 2 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
23.1%
6/26 • Number of events 13 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
General disorders
INJECTION SITE DISCOMFORT
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
5.3%
1/19 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/26 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
General disorders
INJECTION SITE ERYTHEMA
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
5.3%
1/19 • Number of events 2 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
44.4%
4/9 • Number of events 6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
30.8%
8/26 • Number of events 13 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
General disorders
INJECTION SITE HAEMORRHAGE
|
9.1%
1/11 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
7.7%
2/26 • Number of events 2 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
General disorders
INJECTION SITE IRRITATION
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
14.3%
1/7 • Number of events 5 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
55.6%
5/9 • Number of events 23 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/26 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
General disorders
INJECTION SITE OEDEMA
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
11.1%
1/9 • Number of events 2 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/26 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
General disorders
INJECTION SITE PAIN
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
10.5%
2/19 • Number of events 5 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
12.5%
1/8 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
7.7%
2/26 • Number of events 3 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
General disorders
INJECTION SITE PRURITUS
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
3.8%
1/26 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
General disorders
INJECTION SITE RASH
|
9.1%
1/11 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
14.3%
1/7 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
16.7%
1/6 • Number of events 9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
25.0%
2/8 • Number of events 3 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/26 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
General disorders
PERIPHERAL SWELLING
|
9.1%
1/11 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
3.8%
1/26 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
General disorders
PYREXIA
|
27.3%
3/11 • Number of events 3 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
16.7%
1/6 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
26.3%
5/19 • Number of events 6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
11.1%
1/9 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
25.0%
2/8 • Number of events 2 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
15.4%
4/26 • Number of events 8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Immune system disorders
SEASONAL ALLERGY
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
12.5%
1/8 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
7.7%
2/26 • Number of events 4 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Infections and infestations
ABSCESS ORAL
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
3.8%
1/26 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Infections and infestations
BODY TINEA
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
3.8%
1/26 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Infections and infestations
CONJUNCTIVITIS
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
3.8%
1/26 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Infections and infestations
EAR INFECTION
|
9.1%
1/11 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
16.7%
1/6 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
22.2%
2/9 • Number of events 2 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
12.5%
1/8 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
15.4%
4/26 • Number of events 5 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Infections and infestations
FUNGAL SKIN INFECTION
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
3.8%
1/26 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
11.1%
1/9 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/26 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Infections and infestations
INFLUENZA
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
11.1%
1/9 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
11.5%
3/26 • Number of events 5 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Infections and infestations
LABYRINTHITIS
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
3.8%
1/26 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Infections and infestations
NAIL INFECTION
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
5.3%
1/19 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/26 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Infections and infestations
NASOPHARYNGITIS
|
9.1%
1/11 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
14.3%
1/7 • Number of events 2 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
16.7%
1/6 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
21.1%
4/19 • Number of events 4 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
44.4%
4/9 • Number of events 7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
12.5%
1/8 • Number of events 2 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
26.9%
7/26 • Number of events 12 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Infections and infestations
ONYCHOMYCOSIS
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
12.5%
1/8 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/26 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Infections and infestations
PHARYNGITIS
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
7.7%
2/26 • Number of events 3 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Infections and infestations
PHARYNGITIS STREPTOCOCCAL
|
9.1%
1/11 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
11.1%
1/9 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
12.5%
1/8 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
11.5%
3/26 • Number of events 4 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Infections and infestations
PNEUMONIA MYCOPLASMAL
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
3.8%
1/26 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Infections and infestations
SCARLET FEVER
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
3.8%
1/26 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Infections and infestations
SINUSITIS
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
16.7%
1/6 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
7.7%
2/26 • Number of events 3 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Infections and infestations
SKIN CANDIDA
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
11.1%
1/9 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/26 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Infections and infestations
STAPHYLOCOCCAL SKIN INFECTION
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
3.8%
1/26 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Infections and infestations
TOOTH ABSCESS
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
3.8%
1/26 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
18.2%
2/11 • Number of events 3 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
33.3%
2/6 • Number of events 2 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
21.1%
4/19 • Number of events 5 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
12.5%
1/8 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
42.3%
11/26 • Number of events 25 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Infections and infestations
VIRAL RHINITIS
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
3.8%
1/26 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Injury, poisoning and procedural complications
ARTHROPOD BITE
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
16.7%
1/6 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
5.3%
1/19 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
11.1%
1/9 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/26 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Injury, poisoning and procedural complications
CONTUSION
|
9.1%
1/11 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
14.3%
1/7 • Number of events 2 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
44.4%
4/9 • Number of events 5 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
15.4%
4/26 • Number of events 4 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Injury, poisoning and procedural complications
CORNEAL ABRASION
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
3.8%
1/26 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Injury, poisoning and procedural complications
EYE CONTUSION
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
11.1%
1/9 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/26 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Injury, poisoning and procedural complications
EYELID CONTUSION
|
9.1%
1/11 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/26 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Injury, poisoning and procedural complications
FALL
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
14.3%
1/7 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
5.3%
1/19 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
77.8%
7/9 • Number of events 20 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
23.1%
6/26 • Number of events 8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Injury, poisoning and procedural complications
FIBULA FRACTURE
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
22.2%
2/9 • Number of events 2 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/26 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Injury, poisoning and procedural complications
FOOT FRACTURE
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
5.3%
1/19 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
11.1%
1/9 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/26 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Injury, poisoning and procedural complications
HEAD INJURY
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
11.1%
1/9 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/26 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Injury, poisoning and procedural complications
HUMERUS FRACTURE
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
3.8%
1/26 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Injury, poisoning and procedural complications
JOINT INJURY
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
11.1%
1/9 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
3.8%
1/26 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Injury, poisoning and procedural complications
LIGAMENT SPRAIN
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
14.3%
1/7 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
5.3%
1/19 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
22.2%
2/9 • Number of events 2 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
12.5%
1/8 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
7.7%
2/26 • Number of events 2 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Injury, poisoning and procedural complications
LIMB INJURY
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
7.7%
2/26 • Number of events 2 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Injury, poisoning and procedural complications
POST-TRAUMATIC PAIN
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
5.3%
1/19 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
7.7%
2/26 • Number of events 2 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Injury, poisoning and procedural complications
PROCEDURAL PAIN
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
3.8%
1/26 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Injury, poisoning and procedural complications
SKIN ABRASION
|
9.1%
1/11 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
5.3%
1/19 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
11.1%
1/9 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
3.8%
1/26 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Injury, poisoning and procedural complications
SKIN LACERATION
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
3.8%
1/26 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Injury, poisoning and procedural complications
SOFT TISSUE INJURY
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
11.1%
1/9 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/26 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Injury, poisoning and procedural complications
SPINAL COMPRESSION FRACTURE
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
11.1%
1/9 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
3.8%
1/26 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Injury, poisoning and procedural complications
SUNBURN
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
3.8%
1/26 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Injury, poisoning and procedural complications
THERMAL BURN
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
11.1%
1/9 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
3.8%
1/26 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Injury, poisoning and procedural complications
TIBIA FRACTURE
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
11.1%
1/9 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/26 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Injury, poisoning and procedural complications
UPPER LIMB FRACTURE
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
11.1%
1/9 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/26 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Investigations
BLOOD CREATINE PHOSPHOKINASE INCREASED
|
9.1%
1/11 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/26 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Investigations
LYMPH NODE PALPABLE
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
5.3%
1/19 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/26 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
16.7%
1/6 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/26 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
5.3%
1/19 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
33.3%
3/9 • Number of events 3 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
11.5%
3/26 • Number of events 4 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
9.1%
1/11 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
5.3%
1/19 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
22.2%
2/9 • Number of events 2 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
19.2%
5/26 • Number of events 5 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Musculoskeletal and connective tissue disorders
COCCYDYNIA
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
3.8%
1/26 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Musculoskeletal and connective tissue disorders
COSTOCHONDRITIS
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
3.8%
1/26 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC COMPRESSION
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
3.8%
1/26 • Number of events 2 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Musculoskeletal and connective tissue disorders
JOINT CONTRACTURE
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
11.1%
1/9 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
3.8%
1/26 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Musculoskeletal and connective tissue disorders
JOINT SWELLING
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
14.3%
1/7 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
5.3%
1/19 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
3.8%
1/26 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
9.1%
1/11 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
16.7%
1/6 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
7.7%
2/26 • Number of events 2 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE TIGHTNESS
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
11.1%
1/9 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/26 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
11.1%
1/9 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/26 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
5.3%
1/19 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
11.1%
1/9 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
3.8%
1/26 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
16.7%
1/6 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
3.8%
1/26 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Musculoskeletal and connective tissue disorders
OSTEOPOROSIS
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
22.2%
2/9 • Number of events 2 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/26 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
14.3%
1/7 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
33.3%
2/6 • Number of events 2 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
22.2%
2/9 • Number of events 2 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
15.4%
4/26 • Number of events 4 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN JAW
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
3.8%
1/26 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Musculoskeletal and connective tissue disorders
SYNOVIAL CYST
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
11.1%
1/9 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/26 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Nervous system disorders
DIZZINESS
|
9.1%
1/11 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
3.8%
1/26 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Nervous system disorders
HEADACHE
|
18.2%
2/11 • Number of events 2 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
28.6%
2/7 • Number of events 2 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
16.7%
1/6 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
36.8%
7/19 • Number of events 19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
22.2%
2/9 • Number of events 3 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
34.6%
9/26 • Number of events 27 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Nervous system disorders
MOTOR DYSFUNCTION
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
11.1%
1/9 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/26 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Nervous system disorders
SINUS HEADACHE
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
11.1%
1/9 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/26 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Psychiatric disorders
ANGER
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
3.8%
1/26 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Psychiatric disorders
BRUXISM
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
5.3%
1/19 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/26 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Psychiatric disorders
ENURESIS
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
3.8%
1/26 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
11.1%
1/9 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/26 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Renal and urinary disorders
POLYURIA
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
5.3%
1/19 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/26 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Reproductive system and breast disorders
TESTICULAR TORSION
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
3.8%
1/26 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
16.7%
1/6 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/26 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHOSPASM
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
12.5%
1/8 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/26 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
18.2%
2/11 • Number of events 2 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
10.5%
2/19 • Number of events 2 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
11.1%
1/9 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
50.0%
4/8 • Number of events 5 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
26.9%
7/26 • Number of events 11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
9.1%
1/11 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
16.7%
1/6 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
5.3%
1/19 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
7.7%
2/26 • Number of events 13 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Respiratory, thoracic and mediastinal disorders
HICCUPS
|
9.1%
1/11 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/26 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Respiratory, thoracic and mediastinal disorders
LOWER RESPIRATORY TRACT CONGESTION
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
3.8%
1/26 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
9.1%
1/11 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
16.7%
1/6 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
5.3%
1/19 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
22.2%
2/9 • Number of events 3 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
19.2%
5/26 • Number of events 5 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL DISCHARGE DISCOLOURATION
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
16.7%
1/6 • Number of events 2 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/26 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
10.5%
2/19 • Number of events 4 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
15.4%
4/26 • Number of events 6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Respiratory, thoracic and mediastinal disorders
PARANASAL SINUS HYPERSECRETION
|
9.1%
1/11 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/26 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
11.1%
1/9 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/26 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
33.3%
2/6 • Number of events 2 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/26 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Respiratory, thoracic and mediastinal disorders
RHINITIS ALLERGIC
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
3.8%
1/26 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
10.5%
2/19 • Number of events 2 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
11.5%
3/26 • Number of events 5 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Respiratory, thoracic and mediastinal disorders
SLEEP APNOEA SYNDROME
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
3.8%
1/26 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Skin and subcutaneous tissue disorders
ACNE
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
3.8%
1/26 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Skin and subcutaneous tissue disorders
COLD SWEAT
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
3.8%
1/26 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS CONTACT
|
9.1%
1/11 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
5.3%
1/19 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
11.1%
1/9 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/26 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
10.5%
2/19 • Number of events 2 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/26 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Skin and subcutaneous tissue disorders
EPHELIDES
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
3.8%
1/26 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
5.3%
1/19 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/26 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Skin and subcutaneous tissue disorders
INGROWING NAIL
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
5.3%
1/19 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/26 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Skin and subcutaneous tissue disorders
LIVEDO RETICULARIS
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
11.1%
1/9 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/26 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/6 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
3.8%
1/26 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
50.0%
3/6 • Number of events 4 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
5.3%
1/19 • Number of events 2 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
7.7%
2/26 • Number of events 3 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Skin and subcutaneous tissue disorders
SKIN ULCER
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
16.7%
1/6 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/19 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/26 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Vascular disorders
FLUSHING
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
16.7%
1/6 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
5.3%
1/19 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/26 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
|
Vascular disorders
HAEMATOMA
|
0.00%
0/11 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/7 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
16.7%
1/6 • Number of events 1 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
5.3%
1/19 • Number of events 2 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/9 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/8 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
0.00%
0/26 • Baseline up to Week 252
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER