Trial Outcomes & Findings for A Study in Recurrent Glioblastoma (GB) (NCT NCT01582269)
NCT ID: NCT01582269
Last Updated: 2025-11-24
Results Overview
OS is defined as the time from the date of randomization until death from any cause. For participants not known to have died by the data-inclusion cutoff date, OS is censored at the last date they were known to be alive.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
158 participants
Primary outcome timeframe
Randomization to Date of Death from Any Cause (Up To 20.5 Months)
Results posted on
2025-11-24
Participant Flow
All the treated participants who experienced progressive disease or died were considered study completers, while those who withdrew consent or were lost to follow-up were not.
Participant milestones
| Measure |
Arm A: Galunisertib
* Participants received Galunisertib 300 milligrams (mg) orally twice daily (BID) for 14 days, followed by 14 days of rest in a 28-day cycle.
* Treatment continued until disease progression or discontinuation criteria were met.
|
Arm B: Galunisertib + Lomustine
* Participants received Galunisertib 300 mg orally BID for 14 days, followed by 14 days of rest in a 28-day cycle.
* Participants received a first dose of Lomustine at 100 milligrams per square meter (mg/m²) administered orally. Thereafter, starting with the second dose, Lomustine was administered orally once every 6 weeks at 100-130 mg/m², at the discretion of the investigator.
* Treatment continued until disease progression or discontinuation criteria were met.
|
Arm C: Lomustine + Placebo
* Participants received a first dose of Lomustine at 100 mg/m² administered orally. Thereafter, starting with the second dose, Lomustine was administered orally once every 6 weeks at 100-130 mg/m², at the discretion of the investigator.
* Participants received Galunisertib-matched Placebo orally BID for 14 days, followed by 14 days of rest in a 28-day cycle.
* Treatment continued until disease progression or discontinuation criteria were met.
|
|---|---|---|---|
|
Overall Study
STARTED
|
39
|
79
|
40
|
|
Overall Study
Received at Least One Dose of Study Drug
|
39
|
79
|
40
|
|
Overall Study
Safety Analysis Population
|
40
|
78
|
40
|
|
Overall Study
COMPLETED
|
38
|
79
|
40
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Arm A: Galunisertib
* Participants received Galunisertib 300 milligrams (mg) orally twice daily (BID) for 14 days, followed by 14 days of rest in a 28-day cycle.
* Treatment continued until disease progression or discontinuation criteria were met.
|
Arm B: Galunisertib + Lomustine
* Participants received Galunisertib 300 mg orally BID for 14 days, followed by 14 days of rest in a 28-day cycle.
* Participants received a first dose of Lomustine at 100 milligrams per square meter (mg/m²) administered orally. Thereafter, starting with the second dose, Lomustine was administered orally once every 6 weeks at 100-130 mg/m², at the discretion of the investigator.
* Treatment continued until disease progression or discontinuation criteria were met.
|
Arm C: Lomustine + Placebo
* Participants received a first dose of Lomustine at 100 mg/m² administered orally. Thereafter, starting with the second dose, Lomustine was administered orally once every 6 weeks at 100-130 mg/m², at the discretion of the investigator.
* Participants received Galunisertib-matched Placebo orally BID for 14 days, followed by 14 days of rest in a 28-day cycle.
* Treatment continued until disease progression or discontinuation criteria were met.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
Baseline Characteristics
A Study in Recurrent Glioblastoma (GB)
Baseline characteristics by cohort
| Measure |
Arm A: Galunisertib
n=39 Participants
* Participants received Galunisertib 300 mg orally BID for 14 days, followed by 14 days of rest in a 28-day cycle.
* Treatment continued until disease progression, death, or discontinuation criteria were met.
|
Arm B: Galunisertib + Lomustine
n=79 Participants
* Participants received Galunisertib 300 mg orally BID for 14 days, followed by 14 days of rest in a 28-day cycle.
* Participants received a first dose of Lomustine at 100 mg/m² administered orally. Thereafter, starting with the second dose, Lomustine was administered orally once every 6 weeks at 100-130 mg/m², at the discretion of the investigator.
* Treatment continued until disease progression, death, or discontinuation criteria were met.
|
Arm C: Lomustine + Placebo
n=40 Participants
* Participants received a first dose of Lomustine at 100 mg/m² administered orally. Thereafter, starting with the second dose, Lomustine was administered orally once every 6 weeks at 100-130 mg/m², at the discretion of the investigator.
* Participants received Galunisertib-matched Placebo orally BID for 14 days, followed by 14 days of rest in a 28-day cycle.
* Treatment continued until disease progression, death, or discontinuation criteria were met.
|
Total
n=158 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
56.6 years
STANDARD_DEVIATION 10.9 • n=45 Participants
|
57.5 years
STANDARD_DEVIATION 9.3 • n=12929 Participants
|
56.9 years
STANDARD_DEVIATION 10.2 • n=6349 Participants
|
57.1 years
STANDARD_DEVIATION 9.9 • n=4548 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=45 Participants
|
21 Participants
n=12929 Participants
|
17 Participants
n=6349 Participants
|
56 Participants
n=4548 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=45 Participants
|
58 Participants
n=12929 Participants
|
23 Participants
n=6349 Participants
|
102 Participants
n=4548 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=45 Participants
|
6 Participants
n=12929 Participants
|
2 Participants
n=6349 Participants
|
11 Participants
n=4548 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=45 Participants
|
56 Participants
n=12929 Participants
|
27 Participants
n=6349 Participants
|
112 Participants
n=4548 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=45 Participants
|
17 Participants
n=12929 Participants
|
11 Participants
n=6349 Participants
|
35 Participants
n=4548 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
0 Participants
n=4548 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=45 Participants
|
1 Participants
n=12929 Participants
|
1 Participants
n=6349 Participants
|
4 Participants
n=4548 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
0 Participants
n=4548 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=45 Participants
|
2 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
2 Participants
n=4548 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=45 Participants
|
60 Participants
n=12929 Participants
|
29 Participants
n=6349 Participants
|
119 Participants
n=4548 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
0 Participants
n=4548 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=45 Participants
|
16 Participants
n=12929 Participants
|
10 Participants
n=6349 Participants
|
33 Participants
n=4548 Participants
|
|
Region of Enrollment
Canada
|
0 Participants
n=45 Participants
|
3 Participants
n=12929 Participants
|
1 Participants
n=6349 Participants
|
4 Participants
n=4548 Participants
|
|
Region of Enrollment
Belgium
|
3 Participants
n=45 Participants
|
8 Participants
n=12929 Participants
|
3 Participants
n=6349 Participants
|
14 Participants
n=4548 Participants
|
|
Region of Enrollment
United States
|
7 Participants
n=45 Participants
|
8 Participants
n=12929 Participants
|
6 Participants
n=6349 Participants
|
21 Participants
n=4548 Participants
|
|
Region of Enrollment
Poland
|
1 Participants
n=45 Participants
|
1 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
2 Participants
n=4548 Participants
|
|
Region of Enrollment
Italy
|
8 Participants
n=45 Participants
|
14 Participants
n=12929 Participants
|
8 Participants
n=6349 Participants
|
30 Participants
n=4548 Participants
|
|
Region of Enrollment
Australia
|
4 Participants
n=45 Participants
|
14 Participants
n=12929 Participants
|
2 Participants
n=6349 Participants
|
20 Participants
n=4548 Participants
|
|
Region of Enrollment
France
|
7 Participants
n=45 Participants
|
17 Participants
n=12929 Participants
|
11 Participants
n=6349 Participants
|
35 Participants
n=4548 Participants
|
|
Region of Enrollment
Germany
|
4 Participants
n=45 Participants
|
7 Participants
n=12929 Participants
|
5 Participants
n=6349 Participants
|
16 Participants
n=4548 Participants
|
|
Region of Enrollment
Spain
|
5 Participants
n=45 Participants
|
6 Participants
n=12929 Participants
|
3 Participants
n=6349 Participants
|
14 Participants
n=4548 Participants
|
|
Region of Enrollment
Netherlands
|
0 Participants
n=45 Participants
|
1 Participants
n=12929 Participants
|
1 Participants
n=6349 Participants
|
2 Participants
n=4548 Participants
|
PRIMARY outcome
Timeframe: Randomization to Date of Death from Any Cause (Up To 20.5 Months)Population: All randomized participants who received at least one dose of study drug (including the censored participants). Number of participants censored in Arm A: Galunisertib = 9; Arm B: Galunisertib + Lomustine = 8; and Arm C: Lomustine + Placebo = 6.
OS is defined as the time from the date of randomization until death from any cause. For participants not known to have died by the data-inclusion cutoff date, OS is censored at the last date they were known to be alive.
Outcome measures
| Measure |
Arm A: Galunisertib
n=39 Participants
* Participants received Galunisertib 300 mg orally BID for 14 days, followed by 14 days of rest in a 28-day cycle.
* Treatment continued until disease progression, death, or discontinuation criteria were met.
|
Arm B: Galunisertib + Lomustine
n=79 Participants
* Participants received Galunisertib 300 mg orally BID for 14 days, followed by 14 days of rest in a 28-day cycle.
* Participants received a first dose of Lomustine at 100 mg/m² administered orally. Thereafter, starting with the second dose, Lomustine was administered orally once every 6 weeks at 100-130 mg/m², at the discretion of the investigator.
* Treatment continued until disease progression, death, or discontinuation criteria were met.
|
Arm C: Lomustine + Placebo
n=40 Participants
* Participants received a first dose of Lomustine at 100 mg/m² administered orally. Thereafter, starting with the second dose, Lomustine was administered orally once every 6 weeks at 100-130 mg/m², at the discretion of the investigator.
* Participants received Galunisertib-matched Placebo orally BID for 14 days, followed by 14 days of rest in a 28-day cycle.
* Treatment continued until disease progression, death, or discontinuation criteria were met.
|
|---|---|---|---|
|
Overall Survival (OS)
|
8.0 Months
95% credible interval (5.7 to 11.7)
|
6.7 Months
95% credible interval (5.3 to 8.5)
|
7.5 Months
95% credible interval (5.6 to 10.3)
|
SECONDARY outcome
Timeframe: Randomization to Objective Progression or Death Due to Any Cause (Up To 19 Months)Population: All randomized participants who received at least one dose of study drug (including the censored participants). Number of participants censored in Arm A: Galunisertib = 7; Arm B: Galunisertib + Lomustine = 8; and Arm C: Lomustine + Placebo = 4.
PFS was defined as the time from randomization to the date of the first observation of objective disease progression or death from any cause, whichever occurred first. Participants known to be alive and without disease progression were censored at the date of their last objective progression-free disease assessment prior to the initiation of any subsequent systemic anticancer therapy.
Outcome measures
| Measure |
Arm A: Galunisertib
n=39 Participants
* Participants received Galunisertib 300 mg orally BID for 14 days, followed by 14 days of rest in a 28-day cycle.
* Treatment continued until disease progression, death, or discontinuation criteria were met.
|
Arm B: Galunisertib + Lomustine
n=79 Participants
* Participants received Galunisertib 300 mg orally BID for 14 days, followed by 14 days of rest in a 28-day cycle.
* Participants received a first dose of Lomustine at 100 mg/m² administered orally. Thereafter, starting with the second dose, Lomustine was administered orally once every 6 weeks at 100-130 mg/m², at the discretion of the investigator.
* Treatment continued until disease progression, death, or discontinuation criteria were met.
|
Arm C: Lomustine + Placebo
n=40 Participants
* Participants received a first dose of Lomustine at 100 mg/m² administered orally. Thereafter, starting with the second dose, Lomustine was administered orally once every 6 weeks at 100-130 mg/m², at the discretion of the investigator.
* Participants received Galunisertib-matched Placebo orally BID for 14 days, followed by 14 days of rest in a 28-day cycle.
* Treatment continued until disease progression, death, or discontinuation criteria were met.
|
|---|---|---|---|
|
Progression Free Survival (PFS)
|
1.8 Months
Interval 1.6 to 3.0
|
1.8 Months
Interval 1.7 to 1.8
|
1.9 Months
Interval 1.7 to 1.9
|
SECONDARY outcome
Timeframe: Randomization until measured progressive disease (Up To 19 Months)Population: All randomized participants who received at least one dose of study drug.
Tumour response was assessed using Response Assessment in Neuro-Oncology (RANO) criteria. Responses included Complete Response (CR), Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD). CR required disappearance of all enhancing lesions, no new lesions, stable or improved non-enhancing lesions, and no corticosteroid use. PR was defined as ≥50% reduction in enhancing lesion size, no new lesions, stable or improved non-enhancing lesions, and stable or reduced corticosteroid use. SD indicated no significant change in lesion size or clinical status. PD was defined as ≥25% increase in lesion size, new lesions, or clinical deterioration. Percentage of participants with tumor response is defined as the percentage of participants who achieved these tumor responses based on RANO criteria.Participants whose tumor response could not be assessed due to inadequate imaging data were categorized as 'Unknown'.
Outcome measures
| Measure |
Arm A: Galunisertib
n=39 Participants
* Participants received Galunisertib 300 mg orally BID for 14 days, followed by 14 days of rest in a 28-day cycle.
* Treatment continued until disease progression, death, or discontinuation criteria were met.
|
Arm B: Galunisertib + Lomustine
n=79 Participants
* Participants received Galunisertib 300 mg orally BID for 14 days, followed by 14 days of rest in a 28-day cycle.
* Participants received a first dose of Lomustine at 100 mg/m² administered orally. Thereafter, starting with the second dose, Lomustine was administered orally once every 6 weeks at 100-130 mg/m², at the discretion of the investigator.
* Treatment continued until disease progression, death, or discontinuation criteria were met.
|
Arm C: Lomustine + Placebo
n=40 Participants
* Participants received a first dose of Lomustine at 100 mg/m² administered orally. Thereafter, starting with the second dose, Lomustine was administered orally once every 6 weeks at 100-130 mg/m², at the discretion of the investigator.
* Participants received Galunisertib-matched Placebo orally BID for 14 days, followed by 14 days of rest in a 28-day cycle.
* Treatment continued until disease progression, death, or discontinuation criteria were met.
|
|---|---|---|---|
|
Percentage of Participants With Tumour Response
CR
|
0.0 Percentage of participants
|
1.3 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Tumour Response
PR
|
5.1 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Tumour Response
SD
|
25.6 Percentage of participants
|
20.3 Percentage of participants
|
30.0 Percentage of participants
|
|
Percentage of Participants With Tumour Response
PD
|
53.8 Percentage of participants
|
63.3 Percentage of participants
|
65.0 Percentage of participants
|
|
Percentage of Participants With Tumour Response
Unknown
|
15.4 Percentage of participants
|
15.2 Percentage of participants
|
5.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Cycle (C) 1: Day (D)1: Predose, 0.5-2 hours (h), 3.5-5 h, and 48 h post-dose; Day 14: Predose, 0.5-2 h, 3.5-5 h, 24 h, and 48 h post last dosePopulation: All randomized participants who received at least one dose of Galunisertib (Arm A and Arm B) and had evaluable PK data were included in the analysis. As prespecified in the statistical analysis plan, PK analyses of Galunisertib exposure parameters were conducted using data combined from both arms.
The absorption rate constant (Ka) of Galunisertib was estimated using PopPK modeling based on plasma concentration-time data collected during Cycle 1. A two-compartment model with first-order absorption was applied using nonlinear mixed-effects modeling. Samples were collected at the following time points: Cycle 1 Day 1: Predose, 0.5-2 hours (h), 3.5-5 h, and 48 h post-dose; Day 14: Predose, 0.5-2 h, 3.5-5 h, 24 h, and 48 h post last dose. Individual participant Ka values were derived from model-estimated parameters using all available PK timepoints.The reported outcome is the mean of these individual Ka estimates across both treatment arms (Arm A: Galunisertib; Arm B: Galunisertib + Lomustine).
Outcome measures
| Measure |
Arm A: Galunisertib
n=114 Participants
* Participants received Galunisertib 300 mg orally BID for 14 days, followed by 14 days of rest in a 28-day cycle.
* Treatment continued until disease progression, death, or discontinuation criteria were met.
|
Arm B: Galunisertib + Lomustine
* Participants received Galunisertib 300 mg orally BID for 14 days, followed by 14 days of rest in a 28-day cycle.
* Participants received a first dose of Lomustine at 100 mg/m² administered orally. Thereafter, starting with the second dose, Lomustine was administered orally once every 6 weeks at 100-130 mg/m², at the discretion of the investigator.
* Treatment continued until disease progression, death, or discontinuation criteria were met.
|
Arm C: Lomustine + Placebo
* Participants received a first dose of Lomustine at 100 mg/m² administered orally. Thereafter, starting with the second dose, Lomustine was administered orally once every 6 weeks at 100-130 mg/m², at the discretion of the investigator.
* Participants received Galunisertib-matched Placebo orally BID for 14 days, followed by 14 days of rest in a 28-day cycle.
* Treatment continued until disease progression, death, or discontinuation criteria were met.
|
|---|---|---|---|
|
Population Pharmacokinetics (PopPK): Absorption Rate Constant of Galunisertib (Arm A: Galunisertib and Arm B: Galunisertib + Lomustine)
|
2.28 One per hour (1/hour)
Standard Error 26
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle (C) 1: Day (D)1: Predose, 0.5-2 hours (h), 3.5-5 h, and 48 h post-dose; Day 14: Predose, 0.5-2 h, 3.5-5 h, 24 h, and 48 h post last dosePopulation: All randomized participants who received at least one dose of Galunisertib (Arm A and Arm B) and had evaluable PK data were included in the analysis. As prespecified in the statistical analysis plan, PK analyses of Galunisertib exposure parameters were conducted using data combined from both arms.
The Vss at steady state of Galunisertib was estimated using PopPK modeling based on plasma concentration-time data collected during Cycle 1.A two-compartment model was applied using nonlinear mixed-effects modeling. Samples were collected at the following time points: Cycle 1 Day 1: Predose, 0.5-2 hours (h), 3.5-5 h, and 48 h post-dose; Day 14: Predose, 0.5-2 h, 3.5-5 h, 24 h, and 48 h post last dose. Individual participant Vss values were derived from model-estimated parameters using all available PK timepoints. The reported outcome is the mean of individual Vss estimates across both treatment arms (Arm A: Galunisertib; Arm B: Galunisertib + Lomustine).
Outcome measures
| Measure |
Arm A: Galunisertib
n=114 Participants
* Participants received Galunisertib 300 mg orally BID for 14 days, followed by 14 days of rest in a 28-day cycle.
* Treatment continued until disease progression, death, or discontinuation criteria were met.
|
Arm B: Galunisertib + Lomustine
* Participants received Galunisertib 300 mg orally BID for 14 days, followed by 14 days of rest in a 28-day cycle.
* Participants received a first dose of Lomustine at 100 mg/m² administered orally. Thereafter, starting with the second dose, Lomustine was administered orally once every 6 weeks at 100-130 mg/m², at the discretion of the investigator.
* Treatment continued until disease progression, death, or discontinuation criteria were met.
|
Arm C: Lomustine + Placebo
* Participants received a first dose of Lomustine at 100 mg/m² administered orally. Thereafter, starting with the second dose, Lomustine was administered orally once every 6 weeks at 100-130 mg/m², at the discretion of the investigator.
* Participants received Galunisertib-matched Placebo orally BID for 14 days, followed by 14 days of rest in a 28-day cycle.
* Treatment continued until disease progression, death, or discontinuation criteria were met.
|
|---|---|---|---|
|
Population Pharmacokinetics (PopPK): Mean Steady State Apparent Volume of Distribution (Vss) of Galunisertib (Arm A: Galunisertib and Arm B: Galunisertib + Lomustine)
|
175 Liters (L)
Standard Error 8.9
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle (C) 1: Day (D)1: Predose, 0.5-2 hours (h), 3.5-5 h, and 48 h post-dose; Day 14: Predose, 0.5-2 h, 3.5-5 h, 24 h, and 48 h post last dosePopulation: All randomized participants who received at least one dose of Galunisertib (Arm A and Arm B) and had evaluable PK data were included in the analysis. As prespecified in the statistical analysis plan, PK analyses of Galunisertib exposure parameters were conducted using data combined from both arms.
The apparent clearance (CL/F) of Galunisertib was estimated using PopPK modeling based on plasma concentration-time data collected during Cycle 1. A two-compartment model was applied using nonlinear mixed-effects modeling. Samples were collected at the following time points: Cycle 1 Day 1: Predose, 0.5-2 hours (h), 3.5-5 h, and 48 h post-dose; Day 14: Predose, 0.5-2 h, 3.5-5 h, 24 h, and 48 h post last dose. Individual participant CL/F values were derived from model-estimated parameters using all available PK timepoints. The reported outcome is the mean of these individual CL/F estimates across both treatment arms (Arm A: Galunisertib; Arm B: Galunisertib + Lomustine).
Outcome measures
| Measure |
Arm A: Galunisertib
n=114 Participants
* Participants received Galunisertib 300 mg orally BID for 14 days, followed by 14 days of rest in a 28-day cycle.
* Treatment continued until disease progression, death, or discontinuation criteria were met.
|
Arm B: Galunisertib + Lomustine
* Participants received Galunisertib 300 mg orally BID for 14 days, followed by 14 days of rest in a 28-day cycle.
* Participants received a first dose of Lomustine at 100 mg/m² administered orally. Thereafter, starting with the second dose, Lomustine was administered orally once every 6 weeks at 100-130 mg/m², at the discretion of the investigator.
* Treatment continued until disease progression, death, or discontinuation criteria were met.
|
Arm C: Lomustine + Placebo
* Participants received a first dose of Lomustine at 100 mg/m² administered orally. Thereafter, starting with the second dose, Lomustine was administered orally once every 6 weeks at 100-130 mg/m², at the discretion of the investigator.
* Participants received Galunisertib-matched Placebo orally BID for 14 days, followed by 14 days of rest in a 28-day cycle.
* Treatment continued until disease progression, death, or discontinuation criteria were met.
|
|---|---|---|---|
|
Population Pharmacokinetics (PopPK): Mean Population Clearance of Galunisertib (Arm A: Galunisertib and Arm B: Galunisertib + Lomustine)
|
37.5 Liter per hour (L/hr)
Standard Error 5.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 20Population: All randomized participants who received at least one dose of the study drug and had a baseline and at least one post-baseline measurement for this outcome.
The Hopkins Verbal Learning Test-Revised comprises: * 3 Learning Trials: Participants were presented with a list of 12 words (from 3 semantic categories) and were asked to recall them to test verbal learning and memory. * Delayed Recall Trial: Conducted 20-25 minutes after the 3rd learning trial to test memory retention. * Delayed Recognition Trial: Participants identified previously presented words from a list that included 12 distractors to test recognition discrimination. Scoring Components: * Total Recall Score (0-36): Sum of correctly recalled words across the 3 learning trials. * Delayed Recall Score (0-12): Number of correct words recalled after the delay. * Recognition Discrimination Index Score (+12 to -12): Calculated as the number of true positives (correctly identified words) minus false positives (incorrectly identified words, i.e., distractors). For each of the 3 reported scores, higher scores = better neurocognitive performance; lower scores = decline.
Outcome measures
| Measure |
Arm A: Galunisertib
n=36 Participants
* Participants received Galunisertib 300 mg orally BID for 14 days, followed by 14 days of rest in a 28-day cycle.
* Treatment continued until disease progression, death, or discontinuation criteria were met.
|
Arm B: Galunisertib + Lomustine
n=74 Participants
* Participants received Galunisertib 300 mg orally BID for 14 days, followed by 14 days of rest in a 28-day cycle.
* Participants received a first dose of Lomustine at 100 mg/m² administered orally. Thereafter, starting with the second dose, Lomustine was administered orally once every 6 weeks at 100-130 mg/m², at the discretion of the investigator.
* Treatment continued until disease progression, death, or discontinuation criteria were met.
|
Arm C: Lomustine + Placebo
n=39 Participants
* Participants received a first dose of Lomustine at 100 mg/m² administered orally. Thereafter, starting with the second dose, Lomustine was administered orally once every 6 weeks at 100-130 mg/m², at the discretion of the investigator.
* Participants received Galunisertib-matched Placebo orally BID for 14 days, followed by 14 days of rest in a 28-day cycle.
* Treatment continued until disease progression, death, or discontinuation criteria were met.
|
|---|---|---|---|
|
Change From Baseline in Neurocognitive Function Using Hopkins Verbal Learning Test-Revised (HVLT-R)
Total Recall Score
|
-0.2 Score on a scale
Standard Deviation 1.4
|
-0.2 Score on a scale
Standard Deviation 1.2
|
-0.3 Score on a scale
Standard Deviation 1.5
|
|
Change From Baseline in Neurocognitive Function Using Hopkins Verbal Learning Test-Revised (HVLT-R)
Delayed Recall Score
|
-0.8 Score on a scale
Standard Deviation 2.2
|
0.0 Score on a scale
Standard Deviation 1.4
|
0.1 Score on a scale
Standard Deviation 1.3
|
|
Change From Baseline in Neurocognitive Function Using Hopkins Verbal Learning Test-Revised (HVLT-R)
Recognition Discrimination Index Score
|
-1.3 Score on a scale
Standard Deviation 5.1
|
0.7 Score on a scale
Standard Deviation 4.1
|
0.1 Score on a scale
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: Baseline, Month 21Population: All randomized participants who received at least one dose of the study drug and had a baseline and at least one post-baseline measurement for this outcome.
The MDASI-BT assesses the severity of multiple brain tumor-related symptoms and the impact of these symptoms on daily functioning in the last 24 hours. It includes: * 13 core symptoms measuring severity of pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, memory problems, lack of appetite, drowsiness, dry mouth, sadness, vomiting, and numbness/tingling, rated 0-10, where 0 = "not present" and 10 = "as bad as you can imagine." * 9 brain tumor-specific symptoms assess severity of difficulty speaking, weakness, seizures, difficulty understanding, vision changes, appearance changes, bowel pattern changes, concentration problems, and irritability, rated 0-10, where 0 = "not present" and 10 = "as bad as you can imagine." * 6 interference items assess impact on general activity, mood, work, relations, walking, and enjoyment of life, rated 0-10, where 0 = "did not interfere" and 10 = "interfered completely."
Outcome measures
| Measure |
Arm A: Galunisertib
n=38 Participants
* Participants received Galunisertib 300 mg orally BID for 14 days, followed by 14 days of rest in a 28-day cycle.
* Treatment continued until disease progression, death, or discontinuation criteria were met.
|
Arm B: Galunisertib + Lomustine
n=77 Participants
* Participants received Galunisertib 300 mg orally BID for 14 days, followed by 14 days of rest in a 28-day cycle.
* Participants received a first dose of Lomustine at 100 mg/m² administered orally. Thereafter, starting with the second dose, Lomustine was administered orally once every 6 weeks at 100-130 mg/m², at the discretion of the investigator.
* Treatment continued until disease progression, death, or discontinuation criteria were met.
|
Arm C: Lomustine + Placebo
n=38 Participants
* Participants received a first dose of Lomustine at 100 mg/m² administered orally. Thereafter, starting with the second dose, Lomustine was administered orally once every 6 weeks at 100-130 mg/m², at the discretion of the investigator.
* Participants received Galunisertib-matched Placebo orally BID for 14 days, followed by 14 days of rest in a 28-day cycle.
* Treatment continued until disease progression, death, or discontinuation criteria were met.
|
|---|---|---|---|
|
Change From Baseline in MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Symptom and Interference Severity Scores: (Brain Tumor Symptoms, Core Symptoms, Interference Symptoms)
Brain Tumor Symptoms
|
0.0 Score on a scale
Standard Deviation 2.3
|
0.3 Score on a scale
Standard Deviation 1.9
|
-0.3 Score on a scale
Standard Deviation 1.9
|
|
Change From Baseline in MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Symptom and Interference Severity Scores: (Brain Tumor Symptoms, Core Symptoms, Interference Symptoms)
Core Symptoms
|
0.0 Score on a scale
Standard Deviation 1.5
|
0.3 Score on a scale
Standard Deviation 1.5
|
0.3 Score on a scale
Standard Deviation 0.9
|
|
Change From Baseline in MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Symptom and Interference Severity Scores: (Brain Tumor Symptoms, Core Symptoms, Interference Symptoms)
Interference Symptoms
|
0.2 Score on a scale
Standard Deviation 2.8
|
0.8 Score on a scale
Standard Deviation 2.2
|
1.1 Score on a scale
Standard Deviation 3.0
|
Adverse Events
Arm A: Galunisertib
Serious events: 21 serious events
Other events: 34 other events
Deaths: 37 deaths
Arm B: Galunisertib + Lomustine
Serious events: 31 serious events
Other events: 69 other events
Deaths: 75 deaths
Arm C: Lomustine + Placebo
Serious events: 15 serious events
Other events: 31 other events
Deaths: 38 deaths
Arm C: Lomustine + Placebo (Placebo Alone)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Arm A: Galunisertib
n=40 participants at risk
* Participants received Galunisertib 300 mg orally BID for 14 days, followed by 14 days of rest in a 28-day cycle.
* Treatment continued until disease progression, death, or discontinuation criteria were met.
|
Arm B: Galunisertib + Lomustine
n=78 participants at risk
* Participants received Galunisertib 300 mg orally BID for 14 days, followed by 14 days of rest in a 28-day cycle.
* Participants received a first dose of Lomustine at 100 mg/m² administered orally. Thereafter, starting with the second dose, Lomustine was administered orally once every 6 weeks at 100-130 mg/m², at the discretion of the investigator.
* Treatment continued until disease progression, death, or discontinuation criteria were met.
|
Arm C: Lomustine + Placebo
n=39 participants at risk
* Participants received a first dose of Lomustine at 100 mg/m² administered orally. Thereafter, starting with the second dose, Lomustine was administered orally once every 6 weeks at 100-130 mg/m², at the discretion of the investigator.
* Participants received Galunisertib-matched Placebo orally BID for 14 days, followed by 14 days of rest in a 28-day cycle.
* Treatment continued until disease progression, death, or discontinuation criteria were met.
|
Arm C: Lomustine + Placebo (Placebo Alone)
n=1 participants at risk
• Participants randomized to Arm C who did not receive the planned treatment but received Galunisertib-matched placebo alone were categorized under this group.
|
|---|---|---|---|---|
|
Infections and infestations
Sepsis
|
0.00%
0/40 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/78 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.6%
1/39 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Varicella zoster virus infection
|
0.00%
0/40 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/78 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.6%
1/39 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/40 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/78 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/39 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
2.5%
1/40 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/78 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/39 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Meningitis chemical
|
0.00%
0/40 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/78 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.6%
1/39 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/40 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.6%
2/78 • Number of events 3 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/39 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/40 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/78 • Number of events 2 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/39 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Eastern cooperative oncology group performance status worsened
|
2.5%
1/40 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/78 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/39 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Electrocardiogram repolarisation abnormality
|
0.00%
0/40 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/78 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/39 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/40 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/78 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/39 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/40 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/78 • Number of events 2 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/39 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/40 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/78 • Number of events 2 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/39 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/40 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/78 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/39 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/40 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/78 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.6%
1/39 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/40 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/78 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/39 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
2.5%
1/40 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/78 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.1%
2/39 • Number of events 2 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
5.0%
2/40 • Number of events 2 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/78 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/39 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Aphasia
|
2.5%
1/40 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/78 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/39 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/40 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/78 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/39 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Brain oedema
|
5.0%
2/40 • Number of events 2 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.4%
5/78 • Number of events 5 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/39 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Cerebral haemorrhage
|
2.5%
1/40 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/78 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/39 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/40 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/78 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/39 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Facial paresis
|
2.5%
1/40 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/78 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/39 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Headache
|
2.5%
1/40 • Number of events 3 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.8%
3/78 • Number of events 3 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/39 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Hemiparesis
|
5.0%
2/40 • Number of events 2 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.1%
4/78 • Number of events 4 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.6%
1/39 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/40 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/78 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.6%
1/39 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Iiird nerve disorder
|
0.00%
0/40 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/78 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/39 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Intracranial pressure increased
|
0.00%
0/40 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.6%
2/78 • Number of events 2 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/39 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Neurological decompensation
|
0.00%
0/40 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/78 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.6%
1/39 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Non-24-hour sleep-wake disorder
|
2.5%
1/40 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/78 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/39 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Partial seizures
|
2.5%
1/40 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/78 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/39 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Post herpetic neuralgia
|
2.5%
1/40 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/78 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/39 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Seizure
|
17.5%
7/40 • Number of events 8 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.1%
4/78 • Number of events 4 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.6%
1/39 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/40 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/78 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.6%
1/39 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Status epilepticus
|
0.00%
0/40 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/78 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/39 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Subdural hygroma
|
0.00%
0/40 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/78 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.6%
1/39 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Syncope
|
2.5%
1/40 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/78 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/39 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/40 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/78 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/39 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/40 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/78 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/39 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Hallucination
|
2.5%
1/40 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/78 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/39 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/40 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/78 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/39 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Mania
|
0.00%
0/40 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/78 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.6%
1/39 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/40 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/78 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/39 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Psychotic disorder due to a general medical condition
|
2.5%
1/40 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/78 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/39 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/40 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/78 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/39 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/40 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/78 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/39 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/40 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/78 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/39 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
2.5%
1/40 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/78 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/39 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/40 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/78 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.6%
1/39 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Vascular disorders
Hypertension
|
0.00%
0/40 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/78 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.6%
1/39 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Vascular disorders
Hypotension
|
0.00%
0/40 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/78 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/39 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/40 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/78 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/39 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/40 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/78 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.6%
1/39 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/40 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/78 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/39 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/40 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/78 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/39 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/40 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/78 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/39 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
100.0%
1/1 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/40 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/78 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/39 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/40 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/78 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/39 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/40 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/78 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/39 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/40 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/78 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/39 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Asthenia
|
0.00%
0/40 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/78 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/39 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Fatigue
|
0.00%
0/40 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.6%
2/78 • Number of events 2 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/39 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
General physical health deterioration
|
0.00%
0/40 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/78 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.1%
2/39 • Number of events 2 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/40 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/78 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/39 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Oedema peripheral
|
0.00%
0/40 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/78 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/39 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Immune system disorders
Hypersensitivity
|
2.5%
1/40 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/78 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/39 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/40 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/78 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/39 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Cellulitis
|
2.5%
1/40 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/78 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/39 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Clostridium colitis
|
0.00%
0/40 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/78 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/39 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Herpes zoster
|
2.5%
1/40 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/78 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/39 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/40 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/78 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/39 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Pneumonia
|
2.5%
1/40 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/78 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/39 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
Other adverse events
| Measure |
Arm A: Galunisertib
n=40 participants at risk
* Participants received Galunisertib 300 mg orally BID for 14 days, followed by 14 days of rest in a 28-day cycle.
* Treatment continued until disease progression, death, or discontinuation criteria were met.
|
Arm B: Galunisertib + Lomustine
n=78 participants at risk
* Participants received Galunisertib 300 mg orally BID for 14 days, followed by 14 days of rest in a 28-day cycle.
* Participants received a first dose of Lomustine at 100 mg/m² administered orally. Thereafter, starting with the second dose, Lomustine was administered orally once every 6 weeks at 100-130 mg/m², at the discretion of the investigator.
* Treatment continued until disease progression, death, or discontinuation criteria were met.
|
Arm C: Lomustine + Placebo
n=39 participants at risk
* Participants received a first dose of Lomustine at 100 mg/m² administered orally. Thereafter, starting with the second dose, Lomustine was administered orally once every 6 weeks at 100-130 mg/m², at the discretion of the investigator.
* Participants received Galunisertib-matched Placebo orally BID for 14 days, followed by 14 days of rest in a 28-day cycle.
* Treatment continued until disease progression, death, or discontinuation criteria were met.
|
Arm C: Lomustine + Placebo (Placebo Alone)
n=1 participants at risk
• Participants randomized to Arm C who did not receive the planned treatment but received Galunisertib-matched placebo alone were categorized under this group.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.5%
1/40 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.6%
2/78 • Number of events 3 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.3%
4/39 • Number of events 5 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
5.0%
2/40 • Number of events 2 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
11.5%
9/78 • Number of events 11 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.3%
4/39 • Number of events 4 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/40 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.3%
8/78 • Number of events 10 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
3/39 • Number of events 3 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.0%
2/40 • Number of events 4 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
26.9%
21/78 • Number of events 26 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
30.8%
12/39 • Number of events 12 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Pericardial effusion
|
5.0%
2/40 • Number of events 2 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/78 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/39 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Endocrine disorders
Cushingoid
|
2.5%
1/40 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.8%
3/78 • Number of events 3 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.1%
2/39 • Number of events 2 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain
|
7.5%
3/40 • Number of events 3 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.6%
2/78 • Number of events 7 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/39 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.0%
2/40 • Number of events 2 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.6%
2/78 • Number of events 3 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/39 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Constipation
|
5.0%
2/40 • Number of events 2 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
9.0%
7/78 • Number of events 9 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
3/39 • Number of events 4 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Diarrhoea
|
10.0%
4/40 • Number of events 7 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.4%
5/78 • Number of events 8 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
15.4%
6/39 • Number of events 7 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Haemorrhoids
|
5.0%
2/40 • Number of events 2 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/78 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.6%
1/39 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Nausea
|
15.0%
6/40 • Number of events 6 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
13/78 • Number of events 13 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
20.5%
8/39 • Number of events 10 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Stomatitis
|
2.5%
1/40 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/78 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.1%
2/39 • Number of events 2 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
4/40 • Number of events 4 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
17.9%
14/78 • Number of events 16 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
20.5%
8/39 • Number of events 11 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Asthenia
|
2.5%
1/40 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.1%
4/78 • Number of events 4 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/39 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Fatigue
|
25.0%
10/40 • Number of events 10 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
25.6%
20/78 • Number of events 25 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
35.9%
14/39 • Number of events 15 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Oedema peripheral
|
7.5%
3/40 • Number of events 3 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.6%
2/78 • Number of events 2 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.1%
2/39 • Number of events 2 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Pyrexia
|
2.5%
1/40 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.6%
2/78 • Number of events 6 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
3/39 • Number of events 3 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Urinary tract infection
|
5.0%
2/40 • Number of events 2 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.1%
4/78 • Number of events 4 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.6%
1/39 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Alanine aminotransferase increased
|
5.0%
2/40 • Number of events 2 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.8%
3/78 • Number of events 7 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
3/39 • Number of events 3 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/40 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.8%
3/78 • Number of events 12 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
3/39 • Number of events 4 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Platelet count decreased
|
2.5%
1/40 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.1%
4/78 • Number of events 5 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.3%
4/39 • Number of events 4 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Weight decreased
|
2.5%
1/40 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
6/78 • Number of events 9 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/39 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Weight increased
|
2.5%
1/40 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.8%
3/78 • Number of events 3 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
12.8%
5/39 • Number of events 5 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/40 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
6/78 • Number of events 13 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.3%
4/39 • Number of events 4 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/40 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.4%
5/78 • Number of events 5 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/39 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.0%
2/40 • Number of events 2 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
6/78 • Number of events 15 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
3/39 • Number of events 3 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.5%
1/40 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.4%
5/78 • Number of events 6 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.6%
1/39 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
2.5%
1/40 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.1%
4/78 • Number of events 4 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.6%
1/39 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.0%
2/40 • Number of events 2 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.6%
2/78 • Number of events 7 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.6%
1/39 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.0%
2/40 • Number of events 2 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/78 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/39 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.5%
3/40 • Number of events 4 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.6%
2/78 • Number of events 2 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
3/39 • Number of events 3 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/40 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/78 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.1%
2/39 • Number of events 2 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Aphasia
|
15.0%
6/40 • Number of events 7 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.1%
4/78 • Number of events 4 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
3/39 • Number of events 3 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/40 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.1%
4/78 • Number of events 4 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.6%
1/39 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Dizziness
|
2.5%
1/40 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.3%
8/78 • Number of events 9 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.1%
2/39 • Number of events 2 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Headache
|
27.5%
11/40 • Number of events 12 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
25.6%
20/78 • Number of events 27 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
25.6%
10/39 • Number of events 13 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/40 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
9.0%
7/78 • Number of events 9 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
15.4%
6/39 • Number of events 6 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Hypoaesthesia
|
5.0%
2/40 • Number of events 3 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.6%
2/78 • Number of events 2 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/39 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Nervous system disorder
|
2.5%
1/40 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/78 • Number of events 2 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.1%
2/39 • Number of events 2 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Paraesthesia
|
2.5%
1/40 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/78 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.3%
4/39 • Number of events 4 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Seizure
|
5.0%
2/40 • Number of events 2 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.4%
5/78 • Number of events 5 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.3%
4/39 • Number of events 6 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Somnolence
|
2.5%
1/40 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/78 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.1%
2/39 • Number of events 2 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Tremor
|
7.5%
3/40 • Number of events 3 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.6%
2/78 • Number of events 2 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.6%
1/39 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/40 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.8%
3/78 • Number of events 3 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.1%
2/39 • Number of events 2 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Anxiety
|
5.0%
2/40 • Number of events 2 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
6/78 • Number of events 7 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.1%
2/39 • Number of events 2 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Confusional state
|
7.5%
3/40 • Number of events 3 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.4%
5/78 • Number of events 5 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
12.8%
5/39 • Number of events 5 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Depression
|
7.5%
3/40 • Number of events 3 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.8%
3/78 • Number of events 4 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.6%
1/39 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Insomnia
|
5.0%
2/40 • Number of events 2 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.1%
4/78 • Number of events 4 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.1%
2/39 • Number of events 2 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Renal and urinary disorders
Urinary incontinence
|
10.0%
4/40 • Number of events 4 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.6%
2/78 • Number of events 2 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/39 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
5.3%
1/19 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/17 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
—
0/0 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.5%
1/40 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.1%
4/78 • Number of events 11 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.1%
2/39 • Number of events 2 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.5%
1/40 • Number of events 2 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.4%
5/78 • Number of events 7 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.1%
2/39 • Number of events 2 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.0%
2/40 • Number of events 2 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/78 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/39 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Hirsutism
|
5.3%
1/19 • Number of events 1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/17 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
—
0/0 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.5%
5/40 • Number of events 5 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.4%
5/78 • Number of events 5 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/39 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up to 11 years 4 months
* Adverse events were reported for the "Safety Analysis Population." * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60