Trial Outcomes & Findings for Safety and Pharmacokinetics of Cobimetinib in Pediatric and Young Adult Participants With Previously Treated Solid Tumors (NCT NCT02639546)
NCT ID: NCT02639546
Last Updated: 2022-09-16
Results Overview
Dose-Limiting Toxicities (DLTs) were defined as cobimetinib-related adverse events occurring within the first 28 days of each administration of cobimetinib.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
56 participants
Primary outcome timeframe
Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
Results posted on
2022-09-16
Participant Flow
The study was conducted at 17 centers in 7 countries.
A total of 63 participants were screened, of which a total of 56 participants were enrolled. Tumor type was not a determinant of cohort assignment for the phase I portion of the study. The phase II portion of the study was restricted to participants with Low-Grade Glioma.
Participant milestones
| Measure |
Phase I (Tablet) Cobimetinib (0.6 mg/kg)
Dose-Escalation: Participants received 0.6 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Tablet) Cobimetinib (0.8 mg/kg)
Dose-Escalation: Participants received 0.8 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Tablet) Cobimetinib (1 mg/kg)
Dose-Escalation: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (0.6 mg/kg)
Dose-Escalation: Participants received 0.6 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (0.8 mg/kg)
Dose-Escalation: Participants received 0.8 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (1 mg/kg)
Dose-Escalation: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (1.33 mg/kg)
Dose-Escalation: Participants received 1.33 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase II (Suspension) Cobimetinib (1 mg/kg)
Dose-Expansion: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
7
|
8
|
5
|
12
|
|
Overall Study
Tumor Type - Neuroblastoma
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Tumor Type - High-Grade Glioma
|
3
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Tumor Type - Low-Grade Glioma
|
1
|
2
|
4
|
5
|
3
|
2
|
3
|
12
|
|
Overall Study
Tumor Type - Dnet In Noonan's Syndrome Tumor With RAS/RAF/MEK/ERK Pathway Activation
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Tumor Type - Malignant Peripheral Nerve Sheath Tumor
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
|
Overall Study
Tumor Type - Metastatic Mediastinal Yolksac Tumor With RAS/RAF/MEK/ERK Pathway Activation
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Tumor Type - Non-Rhabdomyosarcoma Soft Tissue Sarcoma
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Tumor Type - Plexiform Neurofibroma
|
1
|
2
|
1
|
1
|
2
|
4
|
1
|
0
|
|
Overall Study
Tumor Type - Rhabdoid Tumor/ATRT
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
6
|
6
|
7
|
8
|
5
|
12
|
Reasons for withdrawal
| Measure |
Phase I (Tablet) Cobimetinib (0.6 mg/kg)
Dose-Escalation: Participants received 0.6 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Tablet) Cobimetinib (0.8 mg/kg)
Dose-Escalation: Participants received 0.8 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Tablet) Cobimetinib (1 mg/kg)
Dose-Escalation: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (0.6 mg/kg)
Dose-Escalation: Participants received 0.6 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (0.8 mg/kg)
Dose-Escalation: Participants received 0.8 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (1 mg/kg)
Dose-Escalation: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (1.33 mg/kg)
Dose-Escalation: Participants received 1.33 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase II (Suspension) Cobimetinib (1 mg/kg)
Dose-Expansion: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Death
|
2
|
2
|
1
|
2
|
2
|
2
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
1
|
1
|
0
|
1
|
|
Overall Study
PI, physician decision; no response to trt.
|
2
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
|
Overall Study
Study Terminated By Sponsor
|
0
|
2
|
3
|
4
|
4
|
3
|
3
|
9
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
1
|
0
|
0
|
1
|
2
|
1
|
Baseline Characteristics
Safety and Pharmacokinetics of Cobimetinib in Pediatric and Young Adult Participants With Previously Treated Solid Tumors
Baseline characteristics by cohort
| Measure |
Phase I (Tablet) Cobimetinib (0.6 mg/kg)
n=6 Participants
Dose-Escalation: Participants received 0.6 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Tablet) Cobimetinib (0.8 mg/kg)
n=6 Participants
Dose-Escalation: Participants received 0.8 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Tablet) Cobimetinib (1 mg/kg)
n=6 Participants
Dose-Escalation: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (0.6 mg/kg)
n=6 Participants
Dose-Escalation: Participants received 0.6 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (0.8 mg/kg)
n=7 Participants
Dose-Escalation: Participants received 0.8 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (1 mg/kg)
n=8 Participants
Dose-Escalation: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (1.33 mg/kg)
n=5 Participants
Dose-Escalation: Participants received 1.33 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase II (Suspension) Cobimetinib (1 mg/kg)
n=12 Participants
Dose-Expansion: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
11.8 Years
STANDARD_DEVIATION 3.5 • n=5 Participants
|
9.5 Years
STANDARD_DEVIATION 3.3 • n=7 Participants
|
9.5 Years
STANDARD_DEVIATION 3.4 • n=5 Participants
|
8.5 Years
STANDARD_DEVIATION 1.4 • n=4 Participants
|
9.7 Years
STANDARD_DEVIATION 5.3 • n=21 Participants
|
8.9 Years
STANDARD_DEVIATION 3.1 • n=8 Participants
|
10.2 Years
STANDARD_DEVIATION 3.3 • n=8 Participants
|
8.7 Years
STANDARD_DEVIATION 7.5 • n=24 Participants
|
9.5 Years
STANDARD_DEVIATION 4.6 • n=42 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
7 Participants
n=24 Participants
|
23 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
33 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
11 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
7 Participants
n=24 Participants
|
29 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Not Stated
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
8 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
18 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
White
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
11 Participants
n=24 Participants
|
34 Participants
n=42 Participants
|
|
Tumor Type
Neuroblastoma
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Tumor Type
High-Grade Glioma
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
|
Tumor Type
Low-Grade Glioma
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
12 Participants
n=24 Participants
|
32 Participants
n=42 Participants
|
|
Tumor Type
Dnet In Noonan's Syndrome Tumor With RAS/RAF/MEK/ERK Pathway Activation
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Tumor Type
Malignant Peripheral Nerve Sheath Tumor
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
|
Tumor Type
Metastatic Mediastinal Yolksac Tumor With RAS/RAF/MEK/ERK Pathway Activation
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Tumor Type
Non-Rhabdomyosarcoma Soft Tissue Sarcoma
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Tumor Type
Plexiform Neurofibroma
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
12 Participants
n=42 Participants
|
|
Tumor Type
Rhabdoid Tumor/ATRT
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)Population: The safety evaluable population was defined as all participants who received at least one dose of study drug.
Dose-Limiting Toxicities (DLTs) were defined as cobimetinib-related adverse events occurring within the first 28 days of each administration of cobimetinib.
Outcome measures
| Measure |
Phase I (Tablet) Cobimetinib (0.6 mg/kg)
n=6 Participants
Dose-Escalation: Participants received 0.6 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Tablet) Cobimetinib (0.8 mg/kg)
n=6 Participants
Dose-Escalation: Participants received 0.8 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Tablet) Cobimetinib (1 mg/kg)
n=6 Participants
Dose-Escalation: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (0.6 mg/kg)
n=6 Participants
Dose-Escalation: Participants received 0.6 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (0.8 mg/kg)
n=7 Participants
Dose-Escalation: Participants received 0.8 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (1 mg/kg)
n=8 Participants
Dose-Escalation: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (1.33 mg/kg)
n=5 Participants
Dose-Escalation: Participants received 1.33 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase II (Suspension) Cobimetinib (1 mg/kg)
n=12 Participants
Dose-Expansion: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Dose-Limiting Toxicities (DLTs)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
33.3 Percentage of Participants
|
16.7 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
60.0 Percentage of Participants
|
0 Percentage of Participants
|
PRIMARY outcome
Timeframe: Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)Population: The safety evaluable population was defined as all participants who received at least one dose of study drug.
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as AEs.
Outcome measures
| Measure |
Phase I (Tablet) Cobimetinib (0.6 mg/kg)
n=6 Participants
Dose-Escalation: Participants received 0.6 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Tablet) Cobimetinib (0.8 mg/kg)
n=6 Participants
Dose-Escalation: Participants received 0.8 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Tablet) Cobimetinib (1 mg/kg)
n=6 Participants
Dose-Escalation: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (0.6 mg/kg)
n=6 Participants
Dose-Escalation: Participants received 0.6 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (0.8 mg/kg)
n=7 Participants
Dose-Escalation: Participants received 0.8 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (1 mg/kg)
n=8 Participants
Dose-Escalation: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (1.33 mg/kg)
n=5 Participants
Dose-Escalation: Participants received 1.33 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase II (Suspension) Cobimetinib (1 mg/kg)
n=12 Participants
Dose-Expansion: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Adverse Events (AEs), Including Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)
AEs
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
|
Percentage of Participants With Adverse Events (AEs), Including Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)
SAEs
|
33.3 Percentage of Participants
|
33.3 Percentage of Participants
|
33.3 Percentage of Participants
|
33.3 Percentage of Participants
|
14.3 Percentage of Participants
|
25.0 Percentage of Participants
|
40.0 Percentage of Participants
|
41.7 Percentage of Participants
|
|
Percentage of Participants With Adverse Events (AEs), Including Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)
AESIs
|
33.3 Percentage of Participants
|
33.3 Percentage of Participants
|
33.3 Percentage of Participants
|
50.0 Percentage of Participants
|
42.9 Percentage of Participants
|
25.0 Percentage of Participants
|
100.0 Percentage of Participants
|
58.3 Percentage of Participants
|
PRIMARY outcome
Timeframe: Cycle 1 Day 1 up to Cycle 1 Day 28 (cycle length=28 days)Population: The safety evaluable population was defined as all participants who received at least one dose of study drug.
A prior dose level was defined as an MTD/MAD if at a certain dose level, there were greater than or equal to (\>=) 2 out of 6 participants who had Dose Limiting Toxicities (DLTs).
Outcome measures
| Measure |
Phase I (Tablet) Cobimetinib (0.6 mg/kg)
n=18 Participants
Dose-Escalation: Participants received 0.6 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Tablet) Cobimetinib (0.8 mg/kg)
n=38 Participants
Dose-Escalation: Participants received 0.8 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Tablet) Cobimetinib (1 mg/kg)
Dose-Escalation: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (0.6 mg/kg)
Dose-Escalation: Participants received 0.6 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (0.8 mg/kg)
Dose-Escalation: Participants received 0.8 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (1 mg/kg)
Dose-Escalation: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (1.33 mg/kg)
Dose-Escalation: Participants received 1.33 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase II (Suspension) Cobimetinib (1 mg/kg)
Dose-Expansion: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
|---|---|---|---|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of Cobimetinib
|
0.8 mg/kg
|
1 mg/kg
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline up to disease progression or death due to any cause, whichever occurs first (up to 5 years, 2 months)Population: The safety evaluable population was defined as all participants who received at least one dose of study drug. Participants enrolled into phase I (Dose-Escalation) cohorts independent of their tumor type. As the same criteria were not used to assess response in all tumor types, the efficacy analyses were broken down by tumor type.
Tumor assessment was performed using mINRC for Participants with Neuroblastoma.
Outcome measures
| Measure |
Phase I (Tablet) Cobimetinib (0.6 mg/kg)
n=1 Participants
Dose-Escalation: Participants received 0.6 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Tablet) Cobimetinib (0.8 mg/kg)
Dose-Escalation: Participants received 0.8 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Tablet) Cobimetinib (1 mg/kg)
Dose-Escalation: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (0.6 mg/kg)
Dose-Escalation: Participants received 0.6 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (0.8 mg/kg)
Dose-Escalation: Participants received 0.8 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (1 mg/kg)
Dose-Escalation: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (1.33 mg/kg)
Dose-Escalation: Participants received 1.33 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase II (Suspension) Cobimetinib (1 mg/kg)
Dose-Expansion: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Objective Response (Complete Response (CR) or Partial Response (PR)) as Determined by the Investigator Using Modified International Neuroblastoma Response Criteria (mINRC) for Participants With Neuroblastoma (Phase I)
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline up to disease progression or death due to any cause, whichever occurs first (up to 5 years, 2 months)Population: The safety evaluable population was defined as all participants who received at least one dose of study drug. Participants enrolled into phase I (Dose-Escalation) cohorts independent of their tumor type. For phase II, only one tumor type cohort was opened (LGG). As the same criteria were not used to assess response in all tumor types, the efficacy analyses were broken down by tumor type.
Tumor assessment was performed using Response Assessment in Neuro-Oncology (RANO) criteria for participants with HGG and Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) for participants with LGG. While the data for LGG in the phase II cohort is presented separately in other parts of the record, it was also considered useful to combine the data for LGG from phase I and phase II, which was done here.
Outcome measures
| Measure |
Phase I (Tablet) Cobimetinib (0.6 mg/kg)
n=5 Participants
Dose-Escalation: Participants received 0.6 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Tablet) Cobimetinib (0.8 mg/kg)
n=32 Participants
Dose-Escalation: Participants received 0.8 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Tablet) Cobimetinib (1 mg/kg)
Dose-Escalation: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (0.6 mg/kg)
Dose-Escalation: Participants received 0.6 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (0.8 mg/kg)
Dose-Escalation: Participants received 0.8 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (1 mg/kg)
Dose-Escalation: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (1.33 mg/kg)
Dose-Escalation: Participants received 1.33 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase II (Suspension) Cobimetinib (1 mg/kg)
Dose-Expansion: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Objective Response (CR or PR) as Determined by the Investigator Using RANO Criteria for Participants With High-Grade Glioma (HGG) (Phase I) and RECIST v1.1 for Participants With Low-Grade Glioma (LGG) (Phase I and II)
|
0 Percentage of Participants
|
9.4 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline up to disease progression or death due to any cause, whichever occurs first (up to 5 years, 2 months)Population: The safety evaluable population was defined as all participants who received at least one dose of study drug. Participants enrolled into phase I (Dose-Escalation) cohorts independent of their tumor type. As the same criteria were not used to assess response in all tumor types, the efficacy analyses were broken down by tumor type.
Tumor assessment was performed using RECIST v1.1 for Participants with All Other Tumours.
Outcome measures
| Measure |
Phase I (Tablet) Cobimetinib (0.6 mg/kg)
n=1 Participants
Dose-Escalation: Participants received 0.6 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Tablet) Cobimetinib (0.8 mg/kg)
n=2 Participants
Dose-Escalation: Participants received 0.8 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Tablet) Cobimetinib (1 mg/kg)
n=1 Participants
Dose-Escalation: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (0.6 mg/kg)
n=1 Participants
Dose-Escalation: Participants received 0.6 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (0.8 mg/kg)
n=12 Participants
Dose-Escalation: Participants received 0.8 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (1 mg/kg)
n=1 Participants
Dose-Escalation: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (1.33 mg/kg)
Dose-Escalation: Participants received 1.33 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase II (Suspension) Cobimetinib (1 mg/kg)
Dose-Expansion: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Objective Response (CR or PR) as Determined by the Investigator Using RECIST v1.1 Criteria for Participants With All Other Tumours (Phase I)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline up to disease progression or death due to any cause, whichever occurs first (up to 5 years, 2 months)Population: The safety evaluable population was defined as all participants who received at least one dose of study drug. For phase II, only one tumor type cohort was opened (LGG).
Tumor assessment will be performed using RANO criteria for LGG.
Outcome measures
| Measure |
Phase I (Tablet) Cobimetinib (0.6 mg/kg)
n=12 Participants
Dose-Escalation: Participants received 0.6 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Tablet) Cobimetinib (0.8 mg/kg)
Dose-Escalation: Participants received 0.8 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Tablet) Cobimetinib (1 mg/kg)
Dose-Escalation: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (0.6 mg/kg)
Dose-Escalation: Participants received 0.6 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (0.8 mg/kg)
Dose-Escalation: Participants received 0.8 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (1 mg/kg)
Dose-Escalation: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (1.33 mg/kg)
Dose-Escalation: Participants received 1.33 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase II (Suspension) Cobimetinib (1 mg/kg)
Dose-Expansion: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Objective Response (CR or PR) as Determined by the Investigator Using RANO Criteria for Participants With LGG (Phase II)
|
8.3 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From the time of cobimetinib study drug initiation to the first documented disease progression, or death due to any cause, whichever occurs first (up to 5 years, 2 months)Population: The safety evaluable population was defined as all participants who received at least one dose of study drug. Participants enrolled into phase I (Dose-Escalation) cohorts independent of their tumor type. As the same criteria were not used to assess response in all tumor types, the efficacy analyses were broken down by tumor type.
Tumor assessment was performed using mINRC for Participants with Neuroblastoma.
Outcome measures
| Measure |
Phase I (Tablet) Cobimetinib (0.6 mg/kg)
n=1 Participants
Dose-Escalation: Participants received 0.6 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Tablet) Cobimetinib (0.8 mg/kg)
Dose-Escalation: Participants received 0.8 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Tablet) Cobimetinib (1 mg/kg)
Dose-Escalation: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (0.6 mg/kg)
Dose-Escalation: Participants received 0.6 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (0.8 mg/kg)
Dose-Escalation: Participants received 0.8 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (1 mg/kg)
Dose-Escalation: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (1.33 mg/kg)
Dose-Escalation: Participants received 1.33 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase II (Suspension) Cobimetinib (1 mg/kg)
Dose-Expansion: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
|---|---|---|---|---|---|---|---|---|
|
Progression-Free Survival (PFS) as Determined by the Investigator Using mINRC for Participants With Neuroblastoma (Phase I)
|
1.3 Months
The confidence interval could not be calculated from the data of one participant.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From the time of cobimetinib study drug initiation to the first documented disease progression, or death due to any cause, whichever occurs first (up to 5 years, 2 months)Population: The safety evaluable population was defined as all participants who received at least one dose of study drug. Participants enrolled into phase I (Dose-Escalation) cohorts independent of their tumor type. For phase II, only one tumor type cohort was opened (LGG). As the same criteria were not used to assess response in all tumor types, the efficacy analyses were broken down by tumor type.
Tumor assessment was performed using RANO for participants with HGG and RECIST v1.1 for participants with LGG. While the data for LGG in the phase II cohort is presented separately in other parts of the record, it was also considered useful to combine the data for LGG from phase I and phase II, which was done here.
Outcome measures
| Measure |
Phase I (Tablet) Cobimetinib (0.6 mg/kg)
n=5 Participants
Dose-Escalation: Participants received 0.6 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Tablet) Cobimetinib (0.8 mg/kg)
n=32 Participants
Dose-Escalation: Participants received 0.8 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Tablet) Cobimetinib (1 mg/kg)
Dose-Escalation: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (0.6 mg/kg)
Dose-Escalation: Participants received 0.6 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (0.8 mg/kg)
Dose-Escalation: Participants received 0.8 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (1 mg/kg)
Dose-Escalation: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (1.33 mg/kg)
Dose-Escalation: Participants received 1.33 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase II (Suspension) Cobimetinib (1 mg/kg)
Dose-Expansion: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
|---|---|---|---|---|---|---|---|---|
|
PFS as Determined by the Investigator Using RANO Criteria for Participants With HGG (Phase I) and RECIST v1.1 for Partcipants With LGG (Phase I and II)
|
1.0 Months
Interval 0.6 to
The upper limit could not be calculated from the data due to insufficient number of participants with events.
|
22.0 Months
Interval 9.3 to
The upper limit could not be calculated from the data due to insufficient number of participants with events.
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From the time of cobimetinib study drug initiation to the first documented disease progression, or death due to any cause, whichever occurs first (up to 5 years, 2 months)Population: The safety evaluable population was defined as all participants who received at least one dose of study drug. Participants enrolled into phase I (Dose-Escalation) cohorts independent of their tumor type. As the same criteria were not used to assess response in all tumor types, the efficacy analyses were broken down by tumor type.
Tumor assessment was performed using RECIST v1.1 for Participants with All Other Tumours.
Outcome measures
| Measure |
Phase I (Tablet) Cobimetinib (0.6 mg/kg)
n=1 Participants
Dose-Escalation: Participants received 0.6 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Tablet) Cobimetinib (0.8 mg/kg)
n=2 Participants
Dose-Escalation: Participants received 0.8 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Tablet) Cobimetinib (1 mg/kg)
n=1 Participants
Dose-Escalation: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (0.6 mg/kg)
n=1 Participants
Dose-Escalation: Participants received 0.6 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (0.8 mg/kg)
n=12 Participants
Dose-Escalation: Participants received 0.8 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (1 mg/kg)
n=1 Participants
Dose-Escalation: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (1.33 mg/kg)
Dose-Escalation: Participants received 1.33 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase II (Suspension) Cobimetinib (1 mg/kg)
Dose-Expansion: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
|---|---|---|---|---|---|---|---|---|
|
PFS as Determined by the Investigator Using RECIST v1.1 Criteria for Participants With All Other Tumours (Phase I)
|
NA Months
PFS could not be calculated from the data of 1 participant
|
4.1 Months
Interval 0.7 to
The upper limit could not be calculated from the data due to insufficient number of participants with events.
|
1.1 Months
The upper and lower limits could not be calculated from the data of 1 participant.
|
3.4 Months
The upper and lower limits could not be calculated from the data of 1 participant.
|
NA Months
Interval 18.4 to
The upper limit could not be calculated from the data due to insufficient number of participants with events.
|
0.5 Months
The upper and lower limits could not be calculated from the data of 1 participant.
|
—
|
—
|
PRIMARY outcome
Timeframe: From the time of cobimetinib study drug initiation to the first documented disease progression, or death due to any cause, whichever occurs first (up to 5 years, 2 months)Population: The safety evaluable population was defined as all participants who received at least one dose of study drug. For phase II, only one tumor type cohort was opened (LGG).
Tumor assessment was performed using RANO criteria for Participants with LGG.
Outcome measures
| Measure |
Phase I (Tablet) Cobimetinib (0.6 mg/kg)
n=12 Participants
Dose-Escalation: Participants received 0.6 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Tablet) Cobimetinib (0.8 mg/kg)
Dose-Escalation: Participants received 0.8 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Tablet) Cobimetinib (1 mg/kg)
Dose-Escalation: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (0.6 mg/kg)
Dose-Escalation: Participants received 0.6 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (0.8 mg/kg)
Dose-Escalation: Participants received 0.8 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (1 mg/kg)
Dose-Escalation: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (1.33 mg/kg)
Dose-Escalation: Participants received 1.33 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase II (Suspension) Cobimetinib (1 mg/kg)
Dose-Expansion: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
|---|---|---|---|---|---|---|---|---|
|
PFS as Determined by the Investigator Using RANO Criteria for Participants With LGG (Phase II)
|
18.4 Months
Interval 3.6 to
The upper limit could not be calculated from the data due to insufficient number of participants with events.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 up to Cycle 1 Day 28 (cycle length=28 days)Population: The safety evaluable population was defined as all participants who received at least one dose of study drug.
A prior dose level was defined as an RP2D if at a certain dose level, there were greater than or equal to (≥) 2 out of 6 participants who had Dose Limiting Toxicities (DLTs).
Outcome measures
| Measure |
Phase I (Tablet) Cobimetinib (0.6 mg/kg)
n=38 Participants
Dose-Escalation: Participants received 0.6 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Tablet) Cobimetinib (0.8 mg/kg)
Dose-Escalation: Participants received 0.8 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Tablet) Cobimetinib (1 mg/kg)
Dose-Escalation: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (0.6 mg/kg)
Dose-Escalation: Participants received 0.6 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (0.8 mg/kg)
Dose-Escalation: Participants received 0.8 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (1 mg/kg)
Dose-Escalation: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (1.33 mg/kg)
Dose-Escalation: Participants received 1.33 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase II (Suspension) Cobimetinib (1 mg/kg)
Dose-Expansion: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
|---|---|---|---|---|---|---|---|---|
|
Recommended Phase II Dose (RP2D) of Cobimetinib
|
1 mg/kg
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first occurrence of objective response to disease progression or death due to any cause, whichever occurs first (up to 5 years, 2 months)Population: The safety evaluable population was defined as all participants who received at least one dose of study drug. Participants enrolled into phase I (Dose-Escalation) cohorts independent of their tumor type. For phase II, only one tumor type cohort was opened (LGG). As the same criteria were not used to assess response in all tumor types, the efficacy analyses were broken down by tumor type.
Tumor assessment was performed using RECIST v1.1 criteria for participants with LGG. While the data for LGG in the phase II cohort is presented separately in other parts of the record, it was also considered useful to combine the data for LGG from phase I and phase II, which was done here.
Outcome measures
| Measure |
Phase I (Tablet) Cobimetinib (0.6 mg/kg)
n=3 Participants
Dose-Escalation: Participants received 0.6 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Tablet) Cobimetinib (0.8 mg/kg)
Dose-Escalation: Participants received 0.8 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Tablet) Cobimetinib (1 mg/kg)
Dose-Escalation: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (0.6 mg/kg)
Dose-Escalation: Participants received 0.6 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (0.8 mg/kg)
Dose-Escalation: Participants received 0.8 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (1 mg/kg)
Dose-Escalation: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (1.33 mg/kg)
Dose-Escalation: Participants received 1.33 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase II (Suspension) Cobimetinib (1 mg/kg)
Dose-Expansion: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
|---|---|---|---|---|---|---|---|---|
|
Duration of Response (DOR) as Determined by the Investigator Using RECIST v1.1 for Participants With LGG (Phase I and II)
|
NA Months
No participants experienced an event and DOR was not reached.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first occurrence of objective response to disease progression or death due to any cause, whichever occurs first (up to 5 years, 2 months)Population: The safety evaluable population was defined as all participants who received at least one dose of study drug. For phase II, only one tumor type cohort was opened (LGG).
Tumor assessment was performed using RANO criteria for Participants with LGG.
Outcome measures
| Measure |
Phase I (Tablet) Cobimetinib (0.6 mg/kg)
n=1 Participants
Dose-Escalation: Participants received 0.6 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Tablet) Cobimetinib (0.8 mg/kg)
Dose-Escalation: Participants received 0.8 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Tablet) Cobimetinib (1 mg/kg)
Dose-Escalation: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (0.6 mg/kg)
Dose-Escalation: Participants received 0.6 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (0.8 mg/kg)
Dose-Escalation: Participants received 0.8 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (1 mg/kg)
Dose-Escalation: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (1.33 mg/kg)
Dose-Escalation: Participants received 1.33 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase II (Suspension) Cobimetinib (1 mg/kg)
Dose-Expansion: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
|---|---|---|---|---|---|---|---|---|
|
DOR as Determined by the Investigator RANO Criteria for Participants With LGG (Phase II)
|
NA Months
No participants experienced an event and DOR was not reached.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline until death due to any cause (up to 5 years, 2 months)Population: The safety evaluable population was defined as all participants who received at least one dose of study drug. Participants enrolled into phase I (Dose-Escalation) cohorts independent of their tumor type. As the same criteria were not used to assess response in all tumor types, the efficacy analyses were broken down by tumor type.
OS was defined as the time from initiation of study drug to death from any cause.
Outcome measures
| Measure |
Phase I (Tablet) Cobimetinib (0.6 mg/kg)
n=1 Participants
Dose-Escalation: Participants received 0.6 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Tablet) Cobimetinib (0.8 mg/kg)
Dose-Escalation: Participants received 0.8 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Tablet) Cobimetinib (1 mg/kg)
Dose-Escalation: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (0.6 mg/kg)
Dose-Escalation: Participants received 0.6 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (0.8 mg/kg)
Dose-Escalation: Participants received 0.8 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (1 mg/kg)
Dose-Escalation: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (1.33 mg/kg)
Dose-Escalation: Participants received 1.33 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase II (Suspension) Cobimetinib (1 mg/kg)
Dose-Expansion: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Survival (OS) for Participants With Neuroblastoma (Phase I)
|
4.6 Months
The confidence interval could not be calculated from the data of one participant.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline until death due to any cause (up to 5 years, 2 months)Population: The safety evaluable population was defined as all participants who received at least one dose of study drug. Participants enrolled into phase I (Dose-Escalation) cohorts independent of their tumor type. For phase II, only one tumor type cohort was opened (LGG). As the same criteria were not used to assess response in all tumor types, the efficacy analyses were broken down by tumor type.
OS was defined as the time from initiation of study drug to death from any cause. While the data for LGG in the phase II cohort is presented separately in other parts of the record, it was also considered useful to combine the data for LGG from phase I and phase II, which was done here.
Outcome measures
| Measure |
Phase I (Tablet) Cobimetinib (0.6 mg/kg)
n=5 Participants
Dose-Escalation: Participants received 0.6 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Tablet) Cobimetinib (0.8 mg/kg)
n=32 Participants
Dose-Escalation: Participants received 0.8 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Tablet) Cobimetinib (1 mg/kg)
Dose-Escalation: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (0.6 mg/kg)
Dose-Escalation: Participants received 0.6 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (0.8 mg/kg)
Dose-Escalation: Participants received 0.8 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (1 mg/kg)
Dose-Escalation: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (1.33 mg/kg)
Dose-Escalation: Participants received 1.33 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase II (Suspension) Cobimetinib (1 mg/kg)
Dose-Expansion: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
|---|---|---|---|---|---|---|---|---|
|
OS for Participants With High-Grade Glioma (HGG) (Phase I) and Low-Grade Glioma (LGG) (Phase I and II)
|
1.4 Months
Interval 0.6 to
The upper limit cannot be calculated due to insufficient number of events.
|
NA Months
No participants experienced an event and DOR was not reached.
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline until death due to any cause (up to 5 years, 2 months)Population: The safety evaluable population was defined as all participants who received at least one dose of study drug. Participants enrolled into phase I (Dose-Escalation) cohorts independent of their tumor type. As the same criteria were not used to assess response in all tumor types, the efficacy analyses were broken down by tumor type.
OS was defined as the time from initiation of study drug to death from any cause.
Outcome measures
| Measure |
Phase I (Tablet) Cobimetinib (0.6 mg/kg)
n=1 Participants
Dose-Escalation: Participants received 0.6 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Tablet) Cobimetinib (0.8 mg/kg)
n=2 Participants
Dose-Escalation: Participants received 0.8 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Tablet) Cobimetinib (1 mg/kg)
n=1 Participants
Dose-Escalation: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (0.6 mg/kg)
n=1 Participants
Dose-Escalation: Participants received 0.6 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (0.8 mg/kg)
n=12 Participants
Dose-Escalation: Participants received 0.8 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (1 mg/kg)
n=1 Participants
Dose-Escalation: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (1.33 mg/kg)
Dose-Escalation: Participants received 1.33 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase II (Suspension) Cobimetinib (1 mg/kg)
Dose-Expansion: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
|---|---|---|---|---|---|---|---|---|
|
OS for Participants With All Other Tumours (Phase I)
|
NA Months
The median and 95% confidence interval could not be calculated from the data of one participant.
|
5.5 Months
Interval 0.8 to
The upper limit could not be calculated from the data due to insufficient number of participants with events.
|
1.1 Months
The 95% confidence interval could not be calculated from the data of one participant.
|
6.3 Months
The 95% confidence interval could not be calculated from the data of one participant.
|
NA Months
The median and 95% confidence interval could not be calculated from the data due to insufficient number of participants with events.
|
5.1 Months
The 95% confidence interval could not be calculated from the data of one participant.
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 2, 4, 6, and 24 hours post-dose on Cycle 1 Days 1 and 21 (predose=within 4 hours prior to dose; cycle length=28 days)Population: The PK population was defined as all participants who received at least 1 dose of Cobimetinib and had evaluable PK data. Only participants for whom data were collected are included in the analysis.
Plasma samples for determination of Cobimetinib concentration were collected prior to dosing and at 2, 4, 6 and 24 hours after dosing on Days 1 and 21 of Cycle 1. The sampling will allow determination of Cmax.
Outcome measures
| Measure |
Phase I (Tablet) Cobimetinib (0.6 mg/kg)
n=6 Participants
Dose-Escalation: Participants received 0.6 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Tablet) Cobimetinib (0.8 mg/kg)
n=6 Participants
Dose-Escalation: Participants received 0.8 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Tablet) Cobimetinib (1 mg/kg)
n=6 Participants
Dose-Escalation: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (0.6 mg/kg)
n=6 Participants
Dose-Escalation: Participants received 0.6 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (0.8 mg/kg)
n=7 Participants
Dose-Escalation: Participants received 0.8 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (1 mg/kg)
n=8 Participants
Dose-Escalation: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (1.33 mg/kg)
n=5 Participants
Dose-Escalation: Participants received 1.33 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase II (Suspension) Cobimetinib (1 mg/kg)
n=12 Participants
Dose-Expansion: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
|---|---|---|---|---|---|---|---|---|
|
Maximum Plasma Concentration Observed (Cmax) of Cobimetinib
Cycle 1 Day 1
|
62.0 ng/mL
Geometric Coefficient of Variation 82.3
|
88.3 ng/mL
Geometric Coefficient of Variation 102
|
144 ng/mL
Geometric Coefficient of Variation 58.6
|
51.5 ng/mL
Geometric Coefficient of Variation 73.4
|
67.4 ng/mL
Geometric Coefficient of Variation 165
|
136 ng/mL
Geometric Coefficient of Variation 80.3
|
111 ng/mL
Geometric Coefficient of Variation 37.0
|
44.0 ng/mL
Geometric Coefficient of Variation 69.8
|
|
Maximum Plasma Concentration Observed (Cmax) of Cobimetinib
Cycle 1 Day 21
|
51.1 ng/mL
Geometric Coefficient of Variation 74.0
|
181 ng/mL
Geometric Coefficient of Variation 134
|
193 ng/mL
Geometric Coefficient of Variation 35.0
|
105 ng/mL
Geometric Coefficient of Variation 84.5
|
156 ng/mL
Geometric Coefficient of Variation 91.2
|
179 ng/mL
Geometric Coefficient of Variation 113
|
172 ng/mL
Geometric Coefficient of Variation 60.3
|
116 ng/mL
Geometric Coefficient of Variation 42
|
SECONDARY outcome
Timeframe: Pre-dose, 2, 4, 6, and 24 hours post-dose on Cycle 1 Days 1 and 21 (pre-dose=within 4 hours prior to dose; cycle length=28 days)Population: The PK population was defined as all participants who received at least 1 dose of Cobimetinib and had evaluable PK data. Only participants for whom data were collected are included in the analysis.
Plasma samples for determination of Cobimetinib concentration were collected prior to dosing and at 2, 4, 6 and 24 hours after dosing on Days 1 and 21 of Cycle 1. The sampling will allow determination of Tmax.
Outcome measures
| Measure |
Phase I (Tablet) Cobimetinib (0.6 mg/kg)
n=6 Participants
Dose-Escalation: Participants received 0.6 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Tablet) Cobimetinib (0.8 mg/kg)
n=6 Participants
Dose-Escalation: Participants received 0.8 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Tablet) Cobimetinib (1 mg/kg)
n=6 Participants
Dose-Escalation: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (0.6 mg/kg)
n=6 Participants
Dose-Escalation: Participants received 0.6 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (0.8 mg/kg)
n=7 Participants
Dose-Escalation: Participants received 0.8 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (1 mg/kg)
n=8 Participants
Dose-Escalation: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (1.33 mg/kg)
n=5 Participants
Dose-Escalation: Participants received 1.33 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase II (Suspension) Cobimetinib (1 mg/kg)
n=12 Participants
Dose-Expansion: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
|---|---|---|---|---|---|---|---|---|
|
Time to Cmax (Tmax) of Cobimetinib
Cycle 1 Day 1
|
4 hr
Interval 2.0 to 6.0
|
2 hr
Interval 2.0 to 6.0
|
3 hr
Interval 2.0 to 4.0
|
4 hr
Interval 2.0 to 6.0
|
4 hr
Interval 2.0 to 6.0
|
2 hr
Interval 2.0 to 4.0
|
5 hr
Interval 2.0 to 6.0
|
4 hr
Interval 2.0 to 6.0
|
|
Time to Cmax (Tmax) of Cobimetinib
Cycle 1 Day 21
|
4 hr
Interval 2.0 to 6.0
|
4 hr
Interval 2.0 to 6.0
|
2 hr
Interval 2.0 to 4.0
|
4 hr
Interval 2.0 to 6.0
|
2 hr
Interval 2.0 to 4.0
|
3 hr
Interval 2.0 to 6.0
|
4 hr
Interval 4.0 to 4.0
|
2 hr
Interval 2.0 to 6.0
|
SECONDARY outcome
Timeframe: Pre-dose, 2, 4, 6, and 24 hours post-dose on Cycle 1 Days 1 and 21 (pre-dose=within 4 hours prior to dose; cycle length=28 days)Population: The PK population was defined as all participants who received at least 1 dose of Cobimetinib and had evaluable PK data. Only participants for whom data were collected are included in the analysis.
Plasma samples for determination of Cobimetinib concentration were collected prior to dosing and at 2, 4, 6 and 24 hours after dosing on Days 1 and 21 of Cycle 1. The sampling will allow determination of AUC0-24.
Outcome measures
| Measure |
Phase I (Tablet) Cobimetinib (0.6 mg/kg)
n=6 Participants
Dose-Escalation: Participants received 0.6 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Tablet) Cobimetinib (0.8 mg/kg)
n=6 Participants
Dose-Escalation: Participants received 0.8 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Tablet) Cobimetinib (1 mg/kg)
n=6 Participants
Dose-Escalation: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (0.6 mg/kg)
n=6 Participants
Dose-Escalation: Participants received 0.6 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (0.8 mg/kg)
n=7 Participants
Dose-Escalation: Participants received 0.8 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (1 mg/kg)
n=8 Participants
Dose-Escalation: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (1.33 mg/kg)
n=5 Participants
Dose-Escalation: Participants received 1.33 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase II (Suspension) Cobimetinib (1 mg/kg)
n=12 Participants
Dose-Expansion: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-Time Curve From 0 to 24 Hours (AUC0-24) of Cobimetinib
Cycle 1 Day 1
|
865 hr*ng/mL
Geometric Coefficient of Variation 83.0
|
1006 hr*ng/mL
Geometric Coefficient of Variation 100
|
1432 hr*ng/mL
Geometric Coefficient of Variation 50.0
|
743 hr*ng/mL
Geometric Coefficient of Variation 67.4
|
1111 hr*ng/mL
Geometric Coefficient of Variation 144
|
1627 hr*ng/mL
Geometric Coefficient of Variation 74.0
|
1567 hr*ng/mL
Geometric Coefficient of Variation 33.1
|
589 hr*ng/mL
Geometric Coefficient of Variation 79.5
|
|
Area Under the Concentration-Time Curve From 0 to 24 Hours (AUC0-24) of Cobimetinib
Cycle 1 Day 21
|
836 hr*ng/mL
Geometric Coefficient of Variation 83.5
|
2802 hr*ng/mL
Geometric Coefficient of Variation 111
|
2382 hr*ng/mL
Geometric Coefficient of Variation 38.4
|
1624 hr*ng/mL
Geometric Coefficient of Variation 80.4
|
1805 hr*ng/mL
Geometric Coefficient of Variation 109
|
2562 hr*ng/mL
Geometric Coefficient of Variation 104
|
2511 hr*ng/mL
Geometric Coefficient of Variation 104
|
1402 hr*ng/mL
Geometric Coefficient of Variation 59
|
SECONDARY outcome
Timeframe: Pre-dose, 2, 4, 6, and 24 hours post-dose on Cycle 1 Days 1 and 21; pre-dose on Cycle 2 Day 1 (pre-dose=within 4 hours prior to dose; cycle length=28 days)Population: Please note that for this Outcome Measure, the Apparent Clearance of Cobimetinib could not be calculated/estimated as PK samples were collected only up to 24hr post dosing.
Plasma samples for determination of Cobimetinib concentration were collected prior to dosing and at 2, 4, 6 and 24 hours after dosing on Days 1 and 21 of Cycle 1, and within 4 hours prior to dosing on Day 1 of Cycle 2.
Outcome measures
| Measure |
Phase I (Tablet) Cobimetinib (0.6 mg/kg)
n=6 Participants
Dose-Escalation: Participants received 0.6 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Tablet) Cobimetinib (0.8 mg/kg)
n=6 Participants
Dose-Escalation: Participants received 0.8 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Tablet) Cobimetinib (1 mg/kg)
n=6 Participants
Dose-Escalation: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (0.6 mg/kg)
n=6 Participants
Dose-Escalation: Participants received 0.6 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (0.8 mg/kg)
n=7 Participants
Dose-Escalation: Participants received 0.8 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (1 mg/kg)
n=8 Participants
Dose-Escalation: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (1.33 mg/kg)
n=5 Participants
Dose-Escalation: Participants received 1.33 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase II (Suspension) Cobimetinib (1 mg/kg)
n=12 Participants
Dose-Expansion: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
|---|---|---|---|---|---|---|---|---|
|
Apparent Clearance (CL/F) of Cobimetinib
|
NA L/hr
Geometric Coefficient of Variation NA
The Apparent Clearance of Cobimetinib could not be calculated/estimated as PK samples were collected only up to 24hr post dosing which resulted in insufficient data to calculate CL/F.
|
NA L/hr
Geometric Coefficient of Variation NA
The Apparent Clearance of Cobimetinib could not be calculated/estimated as PK samples were collected only up to 24hr post dosing which resulted in insufficient data to calculate CL/F.
|
NA L/hr
Geometric Coefficient of Variation NA
The Apparent Clearance of Cobimetinib could not be calculated/estimated as PK samples were collected only up to 24hr post dosing which resulted in insufficient data to calculate CL/F.
|
NA L/hr
Geometric Coefficient of Variation NA
The Apparent Clearance of Cobimetinib could not be calculated/estimated as PK samples were collected only up to 24hr post dosing which resulted in insufficient data to calculate CL/F.
|
NA L/hr
Geometric Coefficient of Variation NA
The Apparent Clearance of Cobimetinib could not be calculated/estimated as PK samples were collected only up to 24hr post dosing which resulted in insufficient data to calculate CL/F.
|
NA L/hr
Geometric Coefficient of Variation NA
The Apparent Clearance of Cobimetinib could not be calculated/estimated as PK samples were collected only up to 24hr post dosing which resulted in insufficient data to calculate CL/F.
|
NA L/hr
Geometric Coefficient of Variation NA
The Apparent Clearance of Cobimetinib could not be calculated/estimated as PK samples were collected only up to 24hr post dosing which resulted in insufficient data to calculate CL/F.
|
NA L/hr
Geometric Coefficient of Variation NA
The Apparent Clearance of Cobimetinib could not be calculated/estimated as PK samples were collected only up to 24hr post dosing which resulted in insufficient data to calculate CL/F.
|
Adverse Events
Phase I (Tablet) Cobimetinib (0.6 mg/kg)
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase I (Tablet) Cobimetinib (0.8 mg/kg)
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase I (Tablet) Cobimetinib (1 mg/kg)
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase I (Suspension) Cobimetinib (0.6 mg/kg)
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase I (Suspension) Cobimetinib (0.8 mg/kg)
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Phase I (Suspension) Cobimetinib (1 mg/kg)
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Phase I (Suspension) Cobimetinib (1.33 mg/kg)
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Phase II (Suspension) Cobimetinib (1 mg/kg)
Serious events: 5 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase I (Tablet) Cobimetinib (0.6 mg/kg)
n=6 participants at risk
Dose-Escalation: Participants received 0.6 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Tablet) Cobimetinib (0.8 mg/kg)
n=6 participants at risk
Dose-Escalation: Participants received 0.8 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Tablet) Cobimetinib (1 mg/kg)
n=6 participants at risk
Dose-Escalation: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (0.6 mg/kg)
n=6 participants at risk
Dose-Escalation: Participants received 0.6 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (0.8 mg/kg)
n=7 participants at risk
Dose-Escalation: Participants received 0.8 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (1 mg/kg)
n=8 participants at risk
Dose-Escalation: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (1.33 mg/kg)
n=5 participants at risk
Dose-Escalation: Participants received 1.33 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase II (Suspension) Cobimetinib (1 mg/kg)
n=12 participants at risk
Dose-Expansion: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Cardiac ventricular thrombosis
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
14.3%
1/7 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Cardiac disorders
Pericardial effusion
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Eye disorders
Chorioretinopathy
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
20.0%
1/5 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
12.5%
1/8 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
General disorders
Pyrexia
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 2 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
20.0%
1/5 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
20.0%
1/5 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
8.3%
1/12 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Infections and infestations
Infection
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 2 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Infections and infestations
Paronychia
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
20.0%
1/5 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Infections and infestations
Pneumonia
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
12.5%
1/8 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Infections and infestations
Skin infection
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
12.5%
1/8 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
8.3%
1/12 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Infections and infestations
Vascular device infection
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
20.0%
1/5 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
8.3%
1/12 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
12.5%
1/8 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
8.3%
1/12 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • Number of events 2 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
8.3%
1/12 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
12.5%
1/8 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Nervous system disorders
Seizure
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
8.3%
1/12 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Nervous system disorders
Somnolence
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
Other adverse events
| Measure |
Phase I (Tablet) Cobimetinib (0.6 mg/kg)
n=6 participants at risk
Dose-Escalation: Participants received 0.6 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Tablet) Cobimetinib (0.8 mg/kg)
n=6 participants at risk
Dose-Escalation: Participants received 0.8 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Tablet) Cobimetinib (1 mg/kg)
n=6 participants at risk
Dose-Escalation: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (0.6 mg/kg)
n=6 participants at risk
Dose-Escalation: Participants received 0.6 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (0.8 mg/kg)
n=7 participants at risk
Dose-Escalation: Participants received 0.8 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (1 mg/kg)
n=8 participants at risk
Dose-Escalation: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase I (Suspension) Cobimetinib (1.33 mg/kg)
n=5 participants at risk
Dose-Escalation: Participants received 1.33 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
Phase II (Suspension) Cobimetinib (1 mg/kg)
n=12 participants at risk
Dose-Expansion: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
|
|---|---|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
8.3%
1/12 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
33.3%
2/6 • Number of events 7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 3 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
25.0%
3/12 • Number of events 6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
8.3%
1/12 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
14.3%
1/7 • Number of events 2 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Congenital, familial and genetic disorders
Iris hamartoma
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
25.0%
2/8 • Number of events 3 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
2/12 • Number of events 2 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Endocrine disorders
Precocious puberty
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Eye disorders
Chorioretinopathy
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
20.0%
1/5 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
12.5%
1/8 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Eye disorders
Corneal neovascularisation
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
8.3%
1/12 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Eye disorders
Detachment of retinal pigment epithelium
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
20.0%
1/5 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Eye disorders
Dry eye
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
12.5%
1/8 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Eye disorders
Eye disorder
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
12.5%
1/8 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Eye disorders
Eye pain
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
12.5%
1/8 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Eye disorders
Eyelid ptosis
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
12.5%
1/8 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Eye disorders
Eyelid skin dryness
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Eye disorders
Miosis
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
12.5%
1/8 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Eye disorders
Ocular hyperaemia
|
16.7%
1/6 • Number of events 2 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Eye disorders
Ocular hypertension
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
14.3%
1/7 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Eye disorders
Optic atrophy
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
8.3%
1/12 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Eye disorders
Optic disc disorder
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Eye disorders
Punctate keratitis
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
12.5%
1/8 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
8.3%
1/12 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Eye disorders
Retinal detachment
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Eye disorders
Retinal disorder
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Eye disorders
Serous retinal detachment
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
20.0%
1/5 • Number of events 2 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Eye disorders
Vision blurred
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
14.3%
1/7 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Eye disorders
Visual acuity reduced transiently
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Eye disorders
Visual field defect
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Eye disorders
Visual impairment
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
14.3%
1/7 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
2/6 • Number of events 2 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
50.0%
3/6 • Number of events 3 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
33.3%
2/6 • Number of events 2 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
28.6%
2/7 • Number of events 2 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
12.5%
1/8 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
40.0%
2/5 • Number of events 2 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
25.0%
3/12 • Number of events 7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
14.3%
1/7 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
20.0%
1/5 • Number of events 4 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
8.3%
1/12 • Number of events 2 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Gastrointestinal disorders
Anal haemorrhage
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Gastrointestinal disorders
Anorectal discomfort
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
14.3%
1/7 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
14.3%
1/7 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Gastrointestinal disorders
Constipation
|
50.0%
3/6 • Number of events 3 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
33.3%
2/6 • Number of events 3 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
50.0%
3/6 • Number of events 5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
25.0%
2/8 • Number of events 3 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
20.0%
1/5 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
25.0%
3/12 • Number of events 3 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
8.3%
1/12 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
3/6 • Number of events 5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
66.7%
4/6 • Number of events 17 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
83.3%
5/6 • Number of events 8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
66.7%
4/6 • Number of events 6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
28.6%
2/7 • Number of events 3 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
50.0%
4/8 • Number of events 6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
80.0%
4/5 • Number of events 10 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
33.3%
4/12 • Number of events 11 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Gastrointestinal disorders
Dry mouth
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Gastrointestinal disorders
Dyspepsia
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
12.5%
1/8 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Gastrointestinal disorders
Faeces hard
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
8.3%
1/12 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
12.5%
1/8 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 2 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Gastrointestinal disorders
Haematochezia
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Gastrointestinal disorders
Lip haemorrhage
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Gastrointestinal disorders
Lip ulceration
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
14.3%
1/7 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
20.0%
1/5 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Gastrointestinal disorders
Nausea
|
33.3%
2/6 • Number of events 2 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
50.0%
3/6 • Number of events 3 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
28.6%
2/7 • Number of events 7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
37.5%
3/8 • Number of events 5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
2/12 • Number of events 2 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
12.5%
1/8 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Gastrointestinal disorders
Stomatitis
|
16.7%
1/6 • Number of events 2 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
14.3%
1/7 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
20.0%
1/5 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Gastrointestinal disorders
Tongue ulceration
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 2 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Gastrointestinal disorders
Tooth impacted
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
8.3%
1/12 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
33.3%
2/6 • Number of events 4 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
66.7%
4/6 • Number of events 9 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
33.3%
2/6 • Number of events 2 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
28.6%
2/7 • Number of events 9 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
50.0%
4/8 • Number of events 7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
40.0%
2/5 • Number of events 2 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
58.3%
7/12 • Number of events 14 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
General disorders
Asthenia
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
8.3%
1/12 • Number of events 2 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
General disorders
Chest pain
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
12.5%
1/8 • Number of events 2 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
General disorders
Extravasation
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
20.0%
1/5 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
General disorders
Fatigue
|
33.3%
2/6 • Number of events 2 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
33.3%
2/6 • Number of events 2 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
50.0%
3/6 • Number of events 5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
33.3%
2/6 • Number of events 2 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
28.6%
2/7 • Number of events 3 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
37.5%
3/8 • Number of events 3 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
20.0%
1/5 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
2/12 • Number of events 2 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
General disorders
Gait disturbance
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
General disorders
Inflammation
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
12.5%
1/8 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
General disorders
Localised oedema
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
20.0%
1/5 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
General disorders
Malaise
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
12.5%
1/8 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
General disorders
Mucosal inflammation
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
12.5%
1/8 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
General disorders
Nodule
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
General disorders
Oedema peripheral
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
8.3%
1/12 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
General disorders
Pyrexia
|
33.3%
2/6 • Number of events 2 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 2 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 3 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
14.3%
1/7 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
25.0%
2/8 • Number of events 2 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
40.0%
2/5 • Number of events 3 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
25.0%
3/12 • Number of events 5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
General disorders
Xerosis
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Immune system disorders
Hypersensitivity
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Infections and infestations
Anorectal infection
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
8.3%
1/12 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Infections and infestations
Bronchitis
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
8.3%
1/12 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Infections and infestations
COVID-19
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
8.3%
1/12 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
20.0%
1/5 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
8.3%
1/12 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
12.5%
1/8 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Infections and infestations
Ear infection
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
14.3%
1/7 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
12.5%
1/8 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Infections and infestations
Folliculitis
|
16.7%
1/6 • Number of events 2 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
14.3%
1/7 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Infections and infestations
Fungal skin infection
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Infections and infestations
H1N1 influenza
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
8.3%
1/12 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
20.0%
1/5 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Infections and infestations
Hordeolum
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Infections and infestations
Impetigo
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
12.5%
1/8 • Number of events 2 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Infections and infestations
Influenza
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
20.0%
1/5 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
8.3%
1/12 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Infections and infestations
Localised infection
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Infections and infestations
Nail infection
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
14.3%
1/7 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
2/12 • Number of events 2 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Infections and infestations
Oral herpes
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
12.5%
1/8 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Infections and infestations
Otitis media
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
12.5%
1/8 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Infections and infestations
Paronychia
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
33.3%
2/6 • Number of events 2 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
14.3%
1/7 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
12.5%
1/8 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
20.0%
1/5 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
2/12 • Number of events 2 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
12.5%
1/8 • Number of events 2 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
8.3%
1/12 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Infections and infestations
Rash pustular
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
12.5%
1/8 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
8.3%
1/12 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
2/12 • Number of events 2 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Infections and infestations
Rhinitis
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
20.0%
1/5 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Infections and infestations
Scarlet fever
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
14.3%
1/7 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Infections and infestations
Skin infection
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
12.5%
1/8 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
20.0%
1/5 • Number of events 2 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
20.0%
1/5 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Infections and infestations
Suspected COVID-19
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
8.3%
1/12 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
20.0%
1/5 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
2/12 • Number of events 2 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
20.0%
1/5 • Number of events 2 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Infections and infestations
Varicella
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
14.3%
1/7 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
12.5%
1/8 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
8.3%
1/12 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Infections and infestations
Viral infection
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
12.5%
1/8 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Infections and infestations
Viral tonsillitis
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
20.0%
1/5 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Injury, poisoning and procedural complications
Abdominal injury
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 3 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
12.5%
1/8 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Injury, poisoning and procedural complications
Face injury
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 4 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
12.5%
1/8 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
20.0%
1/5 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
8.3%
1/12 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Injury, poisoning and procedural complications
Foreign body in ear
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Injury, poisoning and procedural complications
Hand fracture
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
20.0%
1/5 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 3 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 2 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
14.3%
1/7 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
12.5%
1/8 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
8.3%
1/12 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
20.0%
1/5 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Injury, poisoning and procedural complications
Skin wound
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
8.3%
1/12 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
20.0%
1/5 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
8.3%
1/12 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Investigations
Alanine aminotransferase increased
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
40.0%
2/5 • Number of events 3 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Investigations
Anion gap increased
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
8.3%
1/12 • Number of events 3 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Investigations
Aspartate aminotransferase increased
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
20.0%
1/5 • Number of events 2 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
8.3%
1/12 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
8.3%
1/12 • Number of events 2 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Investigations
Blood bicarbonate decreased
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
8.3%
1/12 • Number of events 2 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Investigations
Blood chloride increased
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
8.3%
1/12 • Number of events 3 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 3 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
28.6%
2/7 • Number of events 3 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
12.5%
1/8 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
33.3%
4/12 • Number of events 8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Investigations
Blood creatinine decreased
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
8.3%
1/12 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Investigations
Blood creatinine increased
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
14.3%
1/7 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
12.5%
1/8 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Investigations
Body temperature decreased
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Investigations
Body temperature increased
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Investigations
Cortisol decreased
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
14.3%
1/7 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
12.5%
1/8 • Number of events 3 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
20.0%
1/5 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
20.0%
1/5 • Number of events 2 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Investigations
Intraocular pressure increased
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
14.3%
1/7 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Investigations
Lymphocyte count decreased
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 4 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
14.3%
1/7 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
12.5%
1/8 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
2/12 • Number of events 4 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Investigations
Lymphocyte count increased
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Investigations
Mean cell volume increased
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
8.3%
1/12 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
28.6%
2/7 • Number of events 3 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
8.3%
1/12 • Number of events 5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Investigations
Neutrophil count increased
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
20.0%
1/5 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
8.3%
1/12 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Investigations
Oxygen saturation decreased
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Investigations
Platelet count decreased
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
8.3%
1/12 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Investigations
Platelet count increased
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
8.3%
1/12 • Number of events 2 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Investigations
Protein total decreased
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
8.3%
1/12 • Number of events 3 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Investigations
Transaminases increased
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 2 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Investigations
Weight decreased
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
12.5%
1/8 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Investigations
Weight increased
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
2/12 • Number of events 2 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Investigations
White blood cell count decreased
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 9 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
28.6%
2/7 • Number of events 3 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
2/12 • Number of events 8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Investigations
White blood cell count increased
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
20.0%
1/5 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
33.3%
2/6 • Number of events 2 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
28.6%
2/7 • Number of events 2 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
25.0%
2/8 • Number of events 2 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
20.0%
1/5 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
8.3%
1/12 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 3 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
14.3%
1/7 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
14.3%
1/7 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
8.3%
1/12 • Number of events 2 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
14.3%
1/7 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 4 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
33.3%
2/6 • Number of events 6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
20.0%
1/5 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
28.6%
2/7 • Number of events 2 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
14.3%
1/7 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 4 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
25.0%
2/8 • Number of events 2 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
33.3%
2/6 • Number of events 6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
14.3%
1/7 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
25.0%
2/8 • Number of events 2 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
12.5%
1/8 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
12.5%
1/8 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 2 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
28.6%
2/7 • Number of events 2 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
12.5%
1/8 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
33.3%
2/6 • Number of events 6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
28.6%
2/7 • Number of events 3 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
20.0%
1/5 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Musculoskeletal and connective tissue disorders
Spinal deformity
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hair follicle tumour benign
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
8.3%
1/12 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 2 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
20.0%
1/5 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Nervous system disorders
Headache
|
50.0%
3/6 • Number of events 5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
50.0%
3/6 • Number of events 4 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
33.3%
2/6 • Number of events 2 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
33.3%
2/6 • Number of events 4 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
42.9%
3/7 • Number of events 8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
50.0%
4/8 • Number of events 4 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
60.0%
3/5 • Number of events 5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
58.3%
7/12 • Number of events 11 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Nervous system disorders
Lethargy
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
14.3%
1/7 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 4 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Nervous system disorders
Sciatica
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Nervous system disorders
Tremor
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
25.0%
2/8 • Number of events 2 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 2 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
20.0%
1/5 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Psychiatric disorders
Behaviour disorder
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
14.3%
1/7 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Psychiatric disorders
Bradyphrenia
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
8.3%
1/12 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Psychiatric disorders
Inappropriate affect
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
8.3%
1/12 • Number of events 2 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Psychiatric disorders
Insomnia
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
12.5%
1/8 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
20.0%
1/5 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
8.3%
1/12 • Number of events 2 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
8.3%
1/12 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 2 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
8.3%
1/12 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
20.0%
1/5 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Renal and urinary disorders
Urinary hesitation
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 2 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
12.5%
1/8 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 2 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Reproductive system and breast disorders
Balanoposthitis
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Reproductive system and breast disorders
Scrotal ulcer
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Reproductive system and breast disorders
Vulvovaginal pain
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
8.3%
1/12 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
2/6 • Number of events 3 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
33.3%
2/6 • Number of events 4 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
33.3%
2/6 • Number of events 2 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
14.3%
1/7 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
12.5%
1/8 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
25.0%
3/12 • Number of events 5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
16.7%
1/6 • Number of events 3 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
25.0%
2/8 • Number of events 2 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
16.7%
1/6 • Number of events 3 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 2 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
14.3%
1/7 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
20.0%
1/5 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
33.3%
4/12 • Number of events 5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 2 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
33.3%
2/6 • Number of events 2 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
8.3%
1/12 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 2 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
20.0%
1/5 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
8.3%
1/12 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
8.3%
1/12 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Respiratory, thoracic and mediastinal disorders
Sputum decreased
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Skin and subcutaneous tissue disorders
Acne
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
14.3%
1/7 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
20.0%
1/5 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
20.0%
1/5 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Skin and subcutaneous tissue disorders
Dandruff
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
8.3%
1/12 • Number of events 2 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
14.3%
1/7 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
12.5%
1/8 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
60.0%
3/5 • Number of events 3 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
8.3%
1/12 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
12.5%
1/8 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
8.3%
1/12 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
20.0%
1/5 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
33.3%
2/6 • Number of events 6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 2 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
33.3%
2/6 • Number of events 2 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
42.9%
3/7 • Number of events 3 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
25.0%
2/8 • Number of events 2 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
20.0%
1/5 • Number of events 2 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
8.3%
1/12 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
14.3%
1/7 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
12.5%
1/8 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
2/12 • Number of events 2 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
20.0%
1/5 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Skin and subcutaneous tissue disorders
Erythema
|
16.7%
1/6 • Number of events 2 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
14.3%
1/7 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Skin and subcutaneous tissue disorders
Hand dermatitis
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
20.0%
1/5 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Skin and subcutaneous tissue disorders
Hirsutism
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
8.3%
1/12 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
14.3%
1/7 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
16.7%
1/6 • Number of events 2 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
8.3%
1/12 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Skin and subcutaneous tissue disorders
Onychomadesis
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Skin and subcutaneous tissue disorders
Pityriasis alba
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
12.5%
1/8 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
20.0%
1/5 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
8.3%
1/12 • Number of events 2 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
33.3%
2/6 • Number of events 5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 2 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
28.6%
2/7 • Number of events 2 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
12.5%
1/8 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
20.0%
1/5 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
2/12 • Number of events 2 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
8.3%
1/12 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
12.5%
1/8 • Number of events 5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
8.3%
1/12 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
12.5%
1/8 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
8.3%
1/12 • Number of events 2 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Skin and subcutaneous tissue disorders
Seborrhoea
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
20.0%
1/5 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
16.7%
1/6 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
14.3%
1/7 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/12 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Skin and subcutaneous tissue disorders
Telangiectasia
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
8.3%
1/12 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Skin and subcutaneous tissue disorders
Xeroderma
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/7 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
8.3%
1/12 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
|
Vascular disorders
Hypertension
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/6 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
14.3%
1/7 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/8 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
0.00%
0/5 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
8.3%
1/12 • Number of events 1 • Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER