Trial Outcomes & Findings for REGN2810 in Pediatric Patients With Relapsed, Refractory Solid, or Central Nervous System (CNS) Tumors and Safety and Efficacy of REGN2810 in Combination With Radiotherapy in Pediatric Patients With Newly Diagnosed or Recurrent Glioma (NCT NCT03690869)
NCT ID: NCT03690869
Last Updated: 2025-04-08
Results Overview
TEAEs are AEs that developed or worsened during the on-treatment period and any treatment-related AEs that occur during the post-treatment period but prior to initiation of other anticancer therapy. Number of TEAEs reported.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
57 participants
Primary outcome timeframe
From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
Results posted on
2025-04-08
Participant Flow
65 participants were screened; 57 participants were enrolled and had received at least 1 dose of REGN2810 at time of study termination (Sponsor decision)
Participant milestones
| Measure |
SOLID TUMOR < 12 yr REGN2810 3mg/kg
Phase 1 (Cohort A) SOLID TUMOR \< 12 yr REGN2810 3 milligrams/kilogram (mg/kg) every two weeks (Q2W)
|
SOLID TUMOR 12 to <18 yr REGN2810 3mg/kg
Phase 1 (Cohort B) SOLID TUMOR 12 to \<18 yr REGN2810 3mg/kg (Q2W)
|
CNS TUMOR <12 yr REGN2810 3mg/kg
Phase 1 (Cohort C1) Central Nervous System (CNS) TUMOR \<12 yr REGN2810 3mg/kg (Q2W)
|
CNS TUMOR <12 yr REGN2810 4.5mg/kg
Phase 1 (Cohort C2) CNS TUMOR \<12 yr REGN2810 4.5mg/kg (Q2W)
|
CNS TUMOR 12 to <18 yr REGN2810 3mg/kg
Phase 1 (Cohort D) CNS TUMOR 12 to \<18 yr REGN2810 3mg/kg (Q2W)
|
ndDIPG <12 yr REGN2810 4.5mg/kg + Radiotherapy
Efficacy Phase (Cohort E) ndDIPG \<12 yr REGN2810 4.5mg/kg (Q2W) + Radiotherapy (pre-specified to be assessed regardless of which radiation therapy)
|
ndDIPG >=12 yr REGN2810 3mg/kg + Radiotherapy
Efficacy Phase (Cohort F) ndDIPG \>=12 yr REGN2810 3mg/kg (Q2W) + Radiotherapy (pre-specified to be assessed regardless of which radiation therapy)
|
ndHGG >=12 yr REGN2810 3mg/kg + Radiotherapy
Efficacy Phase (Cohort H) ndHGG \>=12 yr REGN2810 3mg/kg (Q2W) + Radiotherapy (pre-specified to be assessed regardless of which radiation therapy)
|
rHGG <12 yr REGN2810 4.5mg/kg + Re-Irradiation
Efficacy Phase (Cohort I) rHGG \<12 yr REGN2810 4.5mg/kg (Q2W) + Re-Irradiation
|
rHGG >= 12 yr REGN2810 3mg/kg + Re-Irradiation
Efficacy Phase (Cohort J) rHGG \>= 12 yr REGN2810 3mg/kg (Q2W) + Re-Irradiation
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
5
|
3
|
9
|
5
|
6
|
5
|
12
|
1
|
8
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
3
|
9
|
5
|
6
|
5
|
11
|
1
|
8
|
Reasons for withdrawal
| Measure |
SOLID TUMOR < 12 yr REGN2810 3mg/kg
Phase 1 (Cohort A) SOLID TUMOR \< 12 yr REGN2810 3 milligrams/kilogram (mg/kg) every two weeks (Q2W)
|
SOLID TUMOR 12 to <18 yr REGN2810 3mg/kg
Phase 1 (Cohort B) SOLID TUMOR 12 to \<18 yr REGN2810 3mg/kg (Q2W)
|
CNS TUMOR <12 yr REGN2810 3mg/kg
Phase 1 (Cohort C1) Central Nervous System (CNS) TUMOR \<12 yr REGN2810 3mg/kg (Q2W)
|
CNS TUMOR <12 yr REGN2810 4.5mg/kg
Phase 1 (Cohort C2) CNS TUMOR \<12 yr REGN2810 4.5mg/kg (Q2W)
|
CNS TUMOR 12 to <18 yr REGN2810 3mg/kg
Phase 1 (Cohort D) CNS TUMOR 12 to \<18 yr REGN2810 3mg/kg (Q2W)
|
ndDIPG <12 yr REGN2810 4.5mg/kg + Radiotherapy
Efficacy Phase (Cohort E) ndDIPG \<12 yr REGN2810 4.5mg/kg (Q2W) + Radiotherapy (pre-specified to be assessed regardless of which radiation therapy)
|
ndDIPG >=12 yr REGN2810 3mg/kg + Radiotherapy
Efficacy Phase (Cohort F) ndDIPG \>=12 yr REGN2810 3mg/kg (Q2W) + Radiotherapy (pre-specified to be assessed regardless of which radiation therapy)
|
ndHGG >=12 yr REGN2810 3mg/kg + Radiotherapy
Efficacy Phase (Cohort H) ndHGG \>=12 yr REGN2810 3mg/kg (Q2W) + Radiotherapy (pre-specified to be assessed regardless of which radiation therapy)
|
rHGG <12 yr REGN2810 4.5mg/kg + Re-Irradiation
Efficacy Phase (Cohort I) rHGG \<12 yr REGN2810 4.5mg/kg (Q2W) + Re-Irradiation
|
rHGG >= 12 yr REGN2810 3mg/kg + Re-Irradiation
Efficacy Phase (Cohort J) rHGG \>= 12 yr REGN2810 3mg/kg (Q2W) + Re-Irradiation
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
1
|
0
|
1
|
|
Overall Study
Death
|
1
|
1
|
1
|
4
|
2
|
5
|
3
|
2
|
0
|
3
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Other Treatment
|
1
|
1
|
1
|
2
|
3
|
1
|
2
|
7
|
0
|
3
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Progressive Disease
|
1
|
2
|
0
|
1
|
0
|
0
|
0
|
0
|
1
|
1
|
|
Overall Study
Subject Decision
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
REGN2810 in Pediatric Patients With Relapsed, Refractory Solid, or Central Nervous System (CNS) Tumors and Safety and Efficacy of REGN2810 in Combination With Radiotherapy in Pediatric Patients With Newly Diagnosed or Recurrent Glioma
Baseline characteristics by cohort
| Measure |
SOLID TUMOR < 12 yr REGN2810 3mg/kg
n=3 Participants
Phase 1 (Cohort A) SOLID TUMOR \< 12 yr REGN2810 3 milligrams/kilogram (mg/kg) every two weeks (Q2W)
|
SOLID TUMOR 12 to <18 yr REGN2810 3mg/kg
n=5 Participants
Phase 1 (Cohort B) SOLID TUMOR 12 to \<18 yr REGN2810 3mg/kg (Q2W)
|
CNS TUMOR <12 yr REGN2810 3mg/kg
n=3 Participants
Phase 1 (Cohort C1) CNS TUMOR \<12 yr REGN2810 3mg/kg (Q2W)
|
CNS TUMOR <12 yr REGN2810 4.5mg/kg
n=9 Participants
Phase 1 (Cohort C2) CNS TUMOR \<12 yr REGN2810 4.5mg/kg (Q2W)
|
CNS TUMOR 12 to <18 yr REGN2810 3mg/kg
n=5 Participants
Phase 1 (Cohort D) CNS TUMOR 12 to \<18 yr REGN2810 3mg/kg (Q2W)
|
ndDIPG <12 yr REGN2810 4.5mg/kg + Radiotherapy
n=6 Participants
Efficacy Phase (Cohort E) ndDIPG \<12 yr REGN2810 4.5mg/kg (Q2W) + Radiotherapy (pre-specified to be assessed regardless of which radiation therapy)
|
ndDIPG >=12 yr REGN2810 3mg/kg + Radiotherapy
n=5 Participants
Efficacy Phase (Cohort F) ndDIPG \>=12 yr REGN2810 3mg/kg (Q2W) + Radiotherapy (pre-specified to be assessed regardless of which radiation therapy)
|
ndHGG >=12 yr REGN2810 3mg/kg + Radiotherapy
n=12 Participants
Efficacy Phase (Cohort H) ndHGG \>=12 yr REGN2810 3mg/kg (Q2W) + Radiotherapy (pre-specified to be assessed regardless of which radiation therapy)
|
rHGG <12 yr REGN2810 4.5mg/kg + Re-Irradiation
n=1 Participants
Efficacy Phase (Cohort I) rHGG \<12 yr REGN2810 4.5mg/kg (Q2W) + Re-Irradiation
|
rHGG >= 12 yr REGN2810 3mg/kg + Re-Irradiation
n=8 Participants
Efficacy Phase (Cohort J) rHGG \>= 12 yr REGN2810 3mg/kg (Q2W) + Re-Irradiation
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
7.0 years
STANDARD_DEVIATION 5.29 • n=93 Participants
|
13.4 years
STANDARD_DEVIATION 1.95 • n=4 Participants
|
7.7 years
STANDARD_DEVIATION 1.53 • n=27 Participants
|
7.1 years
STANDARD_DEVIATION 2.26 • n=483 Participants
|
15.0 years
STANDARD_DEVIATION 1.00 • n=36 Participants
|
4.8 years
STANDARD_DEVIATION 1.83 • n=10 Participants
|
15.4 years
STANDARD_DEVIATION 2.41 • n=115 Participants
|
16.4 years
STANDARD_DEVIATION 3.63 • n=40 Participants
|
8.0 years
STANDARD_DEVIATION 0 • n=8 Participants
|
16.3 years
STANDARD_DEVIATION 3.01 • n=62 Participants
|
12.1 years
STANDARD_DEVIATION 5.23 • n=95 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
4 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
4 Participants
n=40 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=62 Participants
|
25 Participants
n=95 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
8 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
6 Participants
n=62 Participants
|
32 Participants
n=95 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
3 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
5 Participants
n=40 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=62 Participants
|
21 Participants
n=95 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
6 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
5 Participants
n=62 Participants
|
33 Participants
n=95 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
3 Participants
n=95 Participants
|
|
Race/Ethnicity, Customized
White
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
12 Participants
n=40 Participants
|
1 Participants
n=8 Participants
|
4 Participants
n=62 Participants
|
40 Participants
n=95 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=62 Participants
|
6 Participants
n=95 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=62 Participants
|
1 Participants
n=95 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
2 Participants
n=95 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
1 Participants
n=95 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
1 Participants
n=95 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=62 Participants
|
4 Participants
n=95 Participants
|
|
Race/Ethnicity, Customized
Not reported
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
2 Participants
n=95 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)Population: Safety analysis set (SAF): All enrolled participants who have received any study treatment (at least one dose of any component of study treatment in a combination therapy) in each study phase. Participants analyzed according to the study treatment received (as treated).
TEAEs are AEs that developed or worsened during the on-treatment period and any treatment-related AEs that occur during the post-treatment period but prior to initiation of other anticancer therapy. Number of TEAEs reported.
Outcome measures
| Measure |
SOLID TUMOR < 12 yr REGN2810 3mg/kg
n=3 Participants
Phase 1 (Cohort A) SOLID TUMOR \< 12 yr REGN2810 3 milligrams/kilogram (mg/kg) every two weeks (Q2W)
|
SOLID TUMOR 12 to <18 yr REGN2810 3mg/kg
n=5 Participants
Phase 1 (Cohort B) SOLID TUMOR 12 to \<18 yr REGN2810 3mg/kg (Q2W)
|
CNS TUMOR <12 yr REGN2810 3mg/kg
n=3 Participants
Phase 1 (Cohort C1) Central Nervous System (CNS) TUMOR \<12 yr REGN2810 3mg/kg (Q2W)
|
CNS TUMOR <12 yr REGN2810 4.5mg/kg
n=9 Participants
Phase 1 (Cohort C2) CNS TUMOR \<12 yr REGN2810 4.5mg/kg (Q2W)
|
CNS TUMOR 12 to <18 yr REGN2810 3mg/kg
n=5 Participants
Phase 1 (Cohort D) CNS TUMOR 12 to \<18 yr REGN2810 3mg/kg (Q2W)
|
ndDIPG <12 yr REGN2810 4.5mg/kg + Radiotherapy
n=6 Participants
Efficacy Phase (Cohort E) ndDIPG \<12 yr REGN2810 4.5mg/kg (Q2W) + Radiotherapy (pre-specified to be assessed regardless of which radiation therapy)
|
ndDIPG >=12 yr REGN2810 3mg/kg + Radiotherapy
n=5 Participants
Efficacy Phase (Cohort F) ndDIPG \>=12 yr REGN2810 3mg/kg (Q2W) + Radiotherapy (pre-specified to be assessed regardless of which radiation therapy)
|
ndHGG >=12 yr REGN2810 3mg/kg + Radiotherapy
n=12 Participants
Efficacy Phase (Cohort H) ndHGG \>=12 yr REGN2810 3mg/kg (Q2W) + Radiotherapy (pre-specified to be assessed regardless of which radiation therapy)
|
rHGG <12 yr REGN2810 4.5mg/kg + Re-Irradiation
n=1 Participants
Efficacy Phase (Cohort I) rHGG \<12 yr REGN2810 4.5mg/kg (Q2W) + Re-Irradiation
|
rHGG >= 12 yr REGN2810 3mg/kg + Re-Irradiation
n=8 Participants
Efficacy Phase (Cohort J) rHGG \>= 12 yr REGN2810 3mg/kg (Q2W) + Re-Irradiation
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Treatment-emergent Adverse Events (TEAEs)
|
19 Events
|
42 Events
|
24 Events
|
56 Events
|
49 Events
|
108 Events
|
102 Events
|
222 Events
|
28 Events
|
175 Events
|
PRIMARY outcome
Timeframe: From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)Population: Safety analysis set (SAF): All enrolled participants who have received any study treatment (at least one dose of any component of study treatment in a combination therapy) in each study phase. Participants analyzed according to the study treatment received (as treated).
NCI CTCAE version 4.0 was utilized for AE grading of severity: Grade 1 (Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated); Grade 2 (Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL); Grade 3 (Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL); Grade 4 (Life-threatening consequences; urgent intervention indicated); Grade 5 (Death related to AE). Number of NCI grade 3/4/5 Treatment-Emergent Adverse Events (AEs) reported
Outcome measures
| Measure |
SOLID TUMOR < 12 yr REGN2810 3mg/kg
n=3 Participants
Phase 1 (Cohort A) SOLID TUMOR \< 12 yr REGN2810 3 milligrams/kilogram (mg/kg) every two weeks (Q2W)
|
SOLID TUMOR 12 to <18 yr REGN2810 3mg/kg
n=5 Participants
Phase 1 (Cohort B) SOLID TUMOR 12 to \<18 yr REGN2810 3mg/kg (Q2W)
|
CNS TUMOR <12 yr REGN2810 3mg/kg
n=3 Participants
Phase 1 (Cohort C1) Central Nervous System (CNS) TUMOR \<12 yr REGN2810 3mg/kg (Q2W)
|
CNS TUMOR <12 yr REGN2810 4.5mg/kg
n=9 Participants
Phase 1 (Cohort C2) CNS TUMOR \<12 yr REGN2810 4.5mg/kg (Q2W)
|
CNS TUMOR 12 to <18 yr REGN2810 3mg/kg
n=5 Participants
Phase 1 (Cohort D) CNS TUMOR 12 to \<18 yr REGN2810 3mg/kg (Q2W)
|
ndDIPG <12 yr REGN2810 4.5mg/kg + Radiotherapy
n=6 Participants
Efficacy Phase (Cohort E) ndDIPG \<12 yr REGN2810 4.5mg/kg (Q2W) + Radiotherapy (pre-specified to be assessed regardless of which radiation therapy)
|
ndDIPG >=12 yr REGN2810 3mg/kg + Radiotherapy
n=5 Participants
Efficacy Phase (Cohort F) ndDIPG \>=12 yr REGN2810 3mg/kg (Q2W) + Radiotherapy (pre-specified to be assessed regardless of which radiation therapy)
|
ndHGG >=12 yr REGN2810 3mg/kg + Radiotherapy
n=12 Participants
Efficacy Phase (Cohort H) ndHGG \>=12 yr REGN2810 3mg/kg (Q2W) + Radiotherapy (pre-specified to be assessed regardless of which radiation therapy)
|
rHGG <12 yr REGN2810 4.5mg/kg + Re-Irradiation
n=1 Participants
Efficacy Phase (Cohort I) rHGG \<12 yr REGN2810 4.5mg/kg (Q2W) + Re-Irradiation
|
rHGG >= 12 yr REGN2810 3mg/kg + Re-Irradiation
n=8 Participants
Efficacy Phase (Cohort J) rHGG \>= 12 yr REGN2810 3mg/kg (Q2W) + Re-Irradiation
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Severe (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] Grade 3/4/5) TEAEs
|
3 Events
|
5 Events
|
0 Events
|
9 Events
|
4 Events
|
25 Events
|
8 Events
|
19 Events
|
4 Events
|
16 Events
|
PRIMARY outcome
Timeframe: From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)Population: Safety analysis set (SAF): All enrolled participants who have received any study treatment (at least one dose of any component of study treatment in a combination therapy) in each study phase. Participants analyzed according to the study treatment received (as treated).
Number of sponsor-identified irAEs (all grades) reported.
Outcome measures
| Measure |
SOLID TUMOR < 12 yr REGN2810 3mg/kg
n=3 Participants
Phase 1 (Cohort A) SOLID TUMOR \< 12 yr REGN2810 3 milligrams/kilogram (mg/kg) every two weeks (Q2W)
|
SOLID TUMOR 12 to <18 yr REGN2810 3mg/kg
n=5 Participants
Phase 1 (Cohort B) SOLID TUMOR 12 to \<18 yr REGN2810 3mg/kg (Q2W)
|
CNS TUMOR <12 yr REGN2810 3mg/kg
n=3 Participants
Phase 1 (Cohort C1) Central Nervous System (CNS) TUMOR \<12 yr REGN2810 3mg/kg (Q2W)
|
CNS TUMOR <12 yr REGN2810 4.5mg/kg
n=9 Participants
Phase 1 (Cohort C2) CNS TUMOR \<12 yr REGN2810 4.5mg/kg (Q2W)
|
CNS TUMOR 12 to <18 yr REGN2810 3mg/kg
n=5 Participants
Phase 1 (Cohort D) CNS TUMOR 12 to \<18 yr REGN2810 3mg/kg (Q2W)
|
ndDIPG <12 yr REGN2810 4.5mg/kg + Radiotherapy
n=6 Participants
Efficacy Phase (Cohort E) ndDIPG \<12 yr REGN2810 4.5mg/kg (Q2W) + Radiotherapy (pre-specified to be assessed regardless of which radiation therapy)
|
ndDIPG >=12 yr REGN2810 3mg/kg + Radiotherapy
n=5 Participants
Efficacy Phase (Cohort F) ndDIPG \>=12 yr REGN2810 3mg/kg (Q2W) + Radiotherapy (pre-specified to be assessed regardless of which radiation therapy)
|
ndHGG >=12 yr REGN2810 3mg/kg + Radiotherapy
n=12 Participants
Efficacy Phase (Cohort H) ndHGG \>=12 yr REGN2810 3mg/kg (Q2W) + Radiotherapy (pre-specified to be assessed regardless of which radiation therapy)
|
rHGG <12 yr REGN2810 4.5mg/kg + Re-Irradiation
n=1 Participants
Efficacy Phase (Cohort I) rHGG \<12 yr REGN2810 4.5mg/kg (Q2W) + Re-Irradiation
|
rHGG >= 12 yr REGN2810 3mg/kg + Re-Irradiation
n=8 Participants
Efficacy Phase (Cohort J) rHGG \>= 12 yr REGN2810 3mg/kg (Q2W) + Re-Irradiation
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Treatment-emergent Sponsor Identified Immune-related Adverse Events (irAEs)
|
0 Events
|
1 Events
|
0 Events
|
0 Events
|
0 Events
|
2 Events
|
5 Events
|
9 Events
|
0 Events
|
9 Events
|
PRIMARY outcome
Timeframe: From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)Population: Safety analysis set (SAF): All enrolled participants who have received any study treatment (at least one dose of any component of study treatment in a combination therapy) in each study phase. Participants analyzed according to the study treatment received (as treated).
Number of severe treatment-emergent sponsor-identified irAEs reported.
Outcome measures
| Measure |
SOLID TUMOR < 12 yr REGN2810 3mg/kg
n=3 Participants
Phase 1 (Cohort A) SOLID TUMOR \< 12 yr REGN2810 3 milligrams/kilogram (mg/kg) every two weeks (Q2W)
|
SOLID TUMOR 12 to <18 yr REGN2810 3mg/kg
n=5 Participants
Phase 1 (Cohort B) SOLID TUMOR 12 to \<18 yr REGN2810 3mg/kg (Q2W)
|
CNS TUMOR <12 yr REGN2810 3mg/kg
n=3 Participants
Phase 1 (Cohort C1) Central Nervous System (CNS) TUMOR \<12 yr REGN2810 3mg/kg (Q2W)
|
CNS TUMOR <12 yr REGN2810 4.5mg/kg
n=9 Participants
Phase 1 (Cohort C2) CNS TUMOR \<12 yr REGN2810 4.5mg/kg (Q2W)
|
CNS TUMOR 12 to <18 yr REGN2810 3mg/kg
n=5 Participants
Phase 1 (Cohort D) CNS TUMOR 12 to \<18 yr REGN2810 3mg/kg (Q2W)
|
ndDIPG <12 yr REGN2810 4.5mg/kg + Radiotherapy
n=6 Participants
Efficacy Phase (Cohort E) ndDIPG \<12 yr REGN2810 4.5mg/kg (Q2W) + Radiotherapy (pre-specified to be assessed regardless of which radiation therapy)
|
ndDIPG >=12 yr REGN2810 3mg/kg + Radiotherapy
n=5 Participants
Efficacy Phase (Cohort F) ndDIPG \>=12 yr REGN2810 3mg/kg (Q2W) + Radiotherapy (pre-specified to be assessed regardless of which radiation therapy)
|
ndHGG >=12 yr REGN2810 3mg/kg + Radiotherapy
n=12 Participants
Efficacy Phase (Cohort H) ndHGG \>=12 yr REGN2810 3mg/kg (Q2W) + Radiotherapy (pre-specified to be assessed regardless of which radiation therapy)
|
rHGG <12 yr REGN2810 4.5mg/kg + Re-Irradiation
n=1 Participants
Efficacy Phase (Cohort I) rHGG \<12 yr REGN2810 4.5mg/kg (Q2W) + Re-Irradiation
|
rHGG >= 12 yr REGN2810 3mg/kg + Re-Irradiation
n=8 Participants
Efficacy Phase (Cohort J) rHGG \>= 12 yr REGN2810 3mg/kg (Q2W) + Re-Irradiation
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Severe (NCI CTCAE Grade 3/4/5) Treatment-emergent Sponsor Identified irAEs
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
3 Events
|
2 Events
|
0 Events
|
1 Events
|
PRIMARY outcome
Timeframe: From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)Population: Safety analysis set (SAF): All enrolled participants who have received any study treatment (at least one dose of any component of study treatment in a combination therapy) in each study phase. Participants analyzed according to the study treatment received (as treated).
AEs of special interest (AESI) are AEs required to be monitored, documented, and managed in a pre-specified manner as described in the protocol. Number of treatment-emergent AESI reported.
Outcome measures
| Measure |
SOLID TUMOR < 12 yr REGN2810 3mg/kg
n=3 Participants
Phase 1 (Cohort A) SOLID TUMOR \< 12 yr REGN2810 3 milligrams/kilogram (mg/kg) every two weeks (Q2W)
|
SOLID TUMOR 12 to <18 yr REGN2810 3mg/kg
n=5 Participants
Phase 1 (Cohort B) SOLID TUMOR 12 to \<18 yr REGN2810 3mg/kg (Q2W)
|
CNS TUMOR <12 yr REGN2810 3mg/kg
n=3 Participants
Phase 1 (Cohort C1) Central Nervous System (CNS) TUMOR \<12 yr REGN2810 3mg/kg (Q2W)
|
CNS TUMOR <12 yr REGN2810 4.5mg/kg
n=9 Participants
Phase 1 (Cohort C2) CNS TUMOR \<12 yr REGN2810 4.5mg/kg (Q2W)
|
CNS TUMOR 12 to <18 yr REGN2810 3mg/kg
n=5 Participants
Phase 1 (Cohort D) CNS TUMOR 12 to \<18 yr REGN2810 3mg/kg (Q2W)
|
ndDIPG <12 yr REGN2810 4.5mg/kg + Radiotherapy
n=6 Participants
Efficacy Phase (Cohort E) ndDIPG \<12 yr REGN2810 4.5mg/kg (Q2W) + Radiotherapy (pre-specified to be assessed regardless of which radiation therapy)
|
ndDIPG >=12 yr REGN2810 3mg/kg + Radiotherapy
n=5 Participants
Efficacy Phase (Cohort F) ndDIPG \>=12 yr REGN2810 3mg/kg (Q2W) + Radiotherapy (pre-specified to be assessed regardless of which radiation therapy)
|
ndHGG >=12 yr REGN2810 3mg/kg + Radiotherapy
n=12 Participants
Efficacy Phase (Cohort H) ndHGG \>=12 yr REGN2810 3mg/kg (Q2W) + Radiotherapy (pre-specified to be assessed regardless of which radiation therapy)
|
rHGG <12 yr REGN2810 4.5mg/kg + Re-Irradiation
n=1 Participants
Efficacy Phase (Cohort I) rHGG \<12 yr REGN2810 4.5mg/kg (Q2W) + Re-Irradiation
|
rHGG >= 12 yr REGN2810 3mg/kg + Re-Irradiation
n=8 Participants
Efficacy Phase (Cohort J) rHGG \>= 12 yr REGN2810 3mg/kg (Q2W) + Re-Irradiation
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Treatment-emergent AEs of Special Interest (AESI)
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
1 Events
|
5 Events
|
2 Events
|
4 Events
|
0 Events
|
8 Events
|
PRIMARY outcome
Timeframe: From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)Population: Safety analysis set (SAF): All enrolled participants who have received any study treatment (at least one dose of any component of study treatment in a combination therapy) in each study phase. Participants analyzed according to the study treatment received (as treated).
Number of NCI grade 3/4/5 treatment-emergent AESI reported
Outcome measures
| Measure |
SOLID TUMOR < 12 yr REGN2810 3mg/kg
n=3 Participants
Phase 1 (Cohort A) SOLID TUMOR \< 12 yr REGN2810 3 milligrams/kilogram (mg/kg) every two weeks (Q2W)
|
SOLID TUMOR 12 to <18 yr REGN2810 3mg/kg
n=5 Participants
Phase 1 (Cohort B) SOLID TUMOR 12 to \<18 yr REGN2810 3mg/kg (Q2W)
|
CNS TUMOR <12 yr REGN2810 3mg/kg
n=3 Participants
Phase 1 (Cohort C1) Central Nervous System (CNS) TUMOR \<12 yr REGN2810 3mg/kg (Q2W)
|
CNS TUMOR <12 yr REGN2810 4.5mg/kg
n=9 Participants
Phase 1 (Cohort C2) CNS TUMOR \<12 yr REGN2810 4.5mg/kg (Q2W)
|
CNS TUMOR 12 to <18 yr REGN2810 3mg/kg
n=5 Participants
Phase 1 (Cohort D) CNS TUMOR 12 to \<18 yr REGN2810 3mg/kg (Q2W)
|
ndDIPG <12 yr REGN2810 4.5mg/kg + Radiotherapy
n=6 Participants
Efficacy Phase (Cohort E) ndDIPG \<12 yr REGN2810 4.5mg/kg (Q2W) + Radiotherapy (pre-specified to be assessed regardless of which radiation therapy)
|
ndDIPG >=12 yr REGN2810 3mg/kg + Radiotherapy
n=5 Participants
Efficacy Phase (Cohort F) ndDIPG \>=12 yr REGN2810 3mg/kg (Q2W) + Radiotherapy (pre-specified to be assessed regardless of which radiation therapy)
|
ndHGG >=12 yr REGN2810 3mg/kg + Radiotherapy
n=12 Participants
Efficacy Phase (Cohort H) ndHGG \>=12 yr REGN2810 3mg/kg (Q2W) + Radiotherapy (pre-specified to be assessed regardless of which radiation therapy)
|
rHGG <12 yr REGN2810 4.5mg/kg + Re-Irradiation
n=1 Participants
Efficacy Phase (Cohort I) rHGG \<12 yr REGN2810 4.5mg/kg (Q2W) + Re-Irradiation
|
rHGG >= 12 yr REGN2810 3mg/kg + Re-Irradiation
n=8 Participants
Efficacy Phase (Cohort J) rHGG \>= 12 yr REGN2810 3mg/kg (Q2W) + Re-Irradiation
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of NCI Grade 3/4/5 Treatment-emergent AESI
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
1 Events
|
2 Events
|
2 Events
|
4 Events
|
0 Events
|
6 Events
|
PRIMARY outcome
Timeframe: From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)Population: Safety analysis set (SAF): All enrolled participants who have received any study treatment (at least one dose of any component of study treatment in a combination therapy) in each study phase. Participants analyzed according to the study treatment received (as treated).
Number of participants with any TEAE resulting in death reported
Outcome measures
| Measure |
SOLID TUMOR < 12 yr REGN2810 3mg/kg
n=3 Participants
Phase 1 (Cohort A) SOLID TUMOR \< 12 yr REGN2810 3 milligrams/kilogram (mg/kg) every two weeks (Q2W)
|
SOLID TUMOR 12 to <18 yr REGN2810 3mg/kg
n=5 Participants
Phase 1 (Cohort B) SOLID TUMOR 12 to \<18 yr REGN2810 3mg/kg (Q2W)
|
CNS TUMOR <12 yr REGN2810 3mg/kg
n=3 Participants
Phase 1 (Cohort C1) Central Nervous System (CNS) TUMOR \<12 yr REGN2810 3mg/kg (Q2W)
|
CNS TUMOR <12 yr REGN2810 4.5mg/kg
n=9 Participants
Phase 1 (Cohort C2) CNS TUMOR \<12 yr REGN2810 4.5mg/kg (Q2W)
|
CNS TUMOR 12 to <18 yr REGN2810 3mg/kg
n=5 Participants
Phase 1 (Cohort D) CNS TUMOR 12 to \<18 yr REGN2810 3mg/kg (Q2W)
|
ndDIPG <12 yr REGN2810 4.5mg/kg + Radiotherapy
n=6 Participants
Efficacy Phase (Cohort E) ndDIPG \<12 yr REGN2810 4.5mg/kg (Q2W) + Radiotherapy (pre-specified to be assessed regardless of which radiation therapy)
|
ndDIPG >=12 yr REGN2810 3mg/kg + Radiotherapy
n=5 Participants
Efficacy Phase (Cohort F) ndDIPG \>=12 yr REGN2810 3mg/kg (Q2W) + Radiotherapy (pre-specified to be assessed regardless of which radiation therapy)
|
ndHGG >=12 yr REGN2810 3mg/kg + Radiotherapy
n=12 Participants
Efficacy Phase (Cohort H) ndHGG \>=12 yr REGN2810 3mg/kg (Q2W) + Radiotherapy (pre-specified to be assessed regardless of which radiation therapy)
|
rHGG <12 yr REGN2810 4.5mg/kg + Re-Irradiation
n=1 Participants
Efficacy Phase (Cohort I) rHGG \<12 yr REGN2810 4.5mg/kg (Q2W) + Re-Irradiation
|
rHGG >= 12 yr REGN2810 3mg/kg + Re-Irradiation
n=8 Participants
Efficacy Phase (Cohort J) rHGG \>= 12 yr REGN2810 3mg/kg (Q2W) + Re-Irradiation
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Any TEAE Resulting in Death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 36 monthsPopulation: Safety analysis set (SAF): All enrolled participants who have received any study treatment (at least one dose of any component of study treatment in a combination therapy) in each study phase. Participants analyzed according to the study treatment received (as treated).
Number of participants with new or worsened laboratory abnormalities (NCI-CTCAE All Grades) reported in Hematology, Electrolytes, Liver, Chemistry; Grade 1 (Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated); Grade 2 (Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL); Grade 3 (Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL); Grade 4 (Life-threatening consequences; urgent intervention indicated); Grade 5 (Death related to AE).
Outcome measures
| Measure |
SOLID TUMOR < 12 yr REGN2810 3mg/kg
n=3 Participants
Phase 1 (Cohort A) SOLID TUMOR \< 12 yr REGN2810 3 milligrams/kilogram (mg/kg) every two weeks (Q2W)
|
SOLID TUMOR 12 to <18 yr REGN2810 3mg/kg
n=5 Participants
Phase 1 (Cohort B) SOLID TUMOR 12 to \<18 yr REGN2810 3mg/kg (Q2W)
|
CNS TUMOR <12 yr REGN2810 3mg/kg
n=3 Participants
Phase 1 (Cohort C1) Central Nervous System (CNS) TUMOR \<12 yr REGN2810 3mg/kg (Q2W)
|
CNS TUMOR <12 yr REGN2810 4.5mg/kg
n=9 Participants
Phase 1 (Cohort C2) CNS TUMOR \<12 yr REGN2810 4.5mg/kg (Q2W)
|
CNS TUMOR 12 to <18 yr REGN2810 3mg/kg
n=5 Participants
Phase 1 (Cohort D) CNS TUMOR 12 to \<18 yr REGN2810 3mg/kg (Q2W)
|
ndDIPG <12 yr REGN2810 4.5mg/kg + Radiotherapy
n=6 Participants
Efficacy Phase (Cohort E) ndDIPG \<12 yr REGN2810 4.5mg/kg (Q2W) + Radiotherapy (pre-specified to be assessed regardless of which radiation therapy)
|
ndDIPG >=12 yr REGN2810 3mg/kg + Radiotherapy
n=5 Participants
Efficacy Phase (Cohort F) ndDIPG \>=12 yr REGN2810 3mg/kg (Q2W) + Radiotherapy (pre-specified to be assessed regardless of which radiation therapy)
|
ndHGG >=12 yr REGN2810 3mg/kg + Radiotherapy
n=12 Participants
Efficacy Phase (Cohort H) ndHGG \>=12 yr REGN2810 3mg/kg (Q2W) + Radiotherapy (pre-specified to be assessed regardless of which radiation therapy)
|
rHGG <12 yr REGN2810 4.5mg/kg + Re-Irradiation
n=1 Participants
Efficacy Phase (Cohort I) rHGG \<12 yr REGN2810 4.5mg/kg (Q2W) + Re-Irradiation
|
rHGG >= 12 yr REGN2810 3mg/kg + Re-Irradiation
n=8 Participants
Efficacy Phase (Cohort J) rHGG \>= 12 yr REGN2810 3mg/kg (Q2W) + Re-Irradiation
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With at Least One Lab Abnormality (NCI-CTCAE All Grades) in Hematology, Electrolytes, Liver, Chemistry
≥ 1 lab abnormality (All Grades) Hematology
|
3 Participants
|
4 Participants
|
3 Participants
|
7 Participants
|
3 Participants
|
6 Participants
|
4 Participants
|
11 Participants
|
1 Participants
|
8 Participants
|
|
Number of Participants With at Least One Lab Abnormality (NCI-CTCAE All Grades) in Hematology, Electrolytes, Liver, Chemistry
≥ 1 lab abnormality (All Grades) Electrolytes
|
3 Participants
|
3 Participants
|
0 Participants
|
5 Participants
|
2 Participants
|
6 Participants
|
4 Participants
|
9 Participants
|
1 Participants
|
7 Participants
|
|
Number of Participants With at Least One Lab Abnormality (NCI-CTCAE All Grades) in Hematology, Electrolytes, Liver, Chemistry
≥ 1 lab abnormality (All Grades) Liver
|
1 Participants
|
2 Participants
|
0 Participants
|
5 Participants
|
3 Participants
|
4 Participants
|
5 Participants
|
7 Participants
|
1 Participants
|
5 Participants
|
|
Number of Participants With at Least One Lab Abnormality (NCI-CTCAE All Grades) in Hematology, Electrolytes, Liver, Chemistry
≥ 1 lab abnormality (All Grades) Chemistry
|
3 Participants
|
5 Participants
|
3 Participants
|
6 Participants
|
4 Participants
|
6 Participants
|
4 Participants
|
10 Participants
|
1 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: Baseline to 28 daysPopulation: Only Phase 1 participants that were eligible for Dose Limiting Toxicity evaluation.
Number of participants who developed dose limiting toxicities (DLTs) in phase 1 reported
Outcome measures
| Measure |
SOLID TUMOR < 12 yr REGN2810 3mg/kg
n=2 Participants
Phase 1 (Cohort A) SOLID TUMOR \< 12 yr REGN2810 3 milligrams/kilogram (mg/kg) every two weeks (Q2W)
|
SOLID TUMOR 12 to <18 yr REGN2810 3mg/kg
n=5 Participants
Phase 1 (Cohort B) SOLID TUMOR 12 to \<18 yr REGN2810 3mg/kg (Q2W)
|
CNS TUMOR <12 yr REGN2810 3mg/kg
n=3 Participants
Phase 1 (Cohort C1) Central Nervous System (CNS) TUMOR \<12 yr REGN2810 3mg/kg (Q2W)
|
CNS TUMOR <12 yr REGN2810 4.5mg/kg
n=6 Participants
Phase 1 (Cohort C2) CNS TUMOR \<12 yr REGN2810 4.5mg/kg (Q2W)
|
CNS TUMOR 12 to <18 yr REGN2810 3mg/kg
n=5 Participants
Phase 1 (Cohort D) CNS TUMOR 12 to \<18 yr REGN2810 3mg/kg (Q2W)
|
ndDIPG <12 yr REGN2810 4.5mg/kg + Radiotherapy
Efficacy Phase (Cohort E) ndDIPG \<12 yr REGN2810 4.5mg/kg (Q2W) + Radiotherapy (pre-specified to be assessed regardless of which radiation therapy)
|
ndDIPG >=12 yr REGN2810 3mg/kg + Radiotherapy
Efficacy Phase (Cohort F) ndDIPG \>=12 yr REGN2810 3mg/kg (Q2W) + Radiotherapy (pre-specified to be assessed regardless of which radiation therapy)
|
ndHGG >=12 yr REGN2810 3mg/kg + Radiotherapy
Efficacy Phase (Cohort H) ndHGG \>=12 yr REGN2810 3mg/kg (Q2W) + Radiotherapy (pre-specified to be assessed regardless of which radiation therapy)
|
rHGG <12 yr REGN2810 4.5mg/kg + Re-Irradiation
Efficacy Phase (Cohort I) rHGG \<12 yr REGN2810 4.5mg/kg (Q2W) + Re-Irradiation
|
rHGG >= 12 yr REGN2810 3mg/kg + Re-Irradiation
Efficacy Phase (Cohort J) rHGG \>= 12 yr REGN2810 3mg/kg (Q2W) + Re-Irradiation
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Developed Dose Limiting Toxicities (DLTs) (Phase 1)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 4 weeks post radiation therapyPopulation: Only Efficacy Phase participants that were eligible for Dose Limiting Toxicity evaluation.
Outcome measures
| Measure |
SOLID TUMOR < 12 yr REGN2810 3mg/kg
n=6 Participants
Phase 1 (Cohort A) SOLID TUMOR \< 12 yr REGN2810 3 milligrams/kilogram (mg/kg) every two weeks (Q2W)
|
SOLID TUMOR 12 to <18 yr REGN2810 3mg/kg
n=5 Participants
Phase 1 (Cohort B) SOLID TUMOR 12 to \<18 yr REGN2810 3mg/kg (Q2W)
|
CNS TUMOR <12 yr REGN2810 3mg/kg
n=6 Participants
Phase 1 (Cohort C1) Central Nervous System (CNS) TUMOR \<12 yr REGN2810 3mg/kg (Q2W)
|
CNS TUMOR <12 yr REGN2810 4.5mg/kg
n=1 Participants
Phase 1 (Cohort C2) CNS TUMOR \<12 yr REGN2810 4.5mg/kg (Q2W)
|
CNS TUMOR 12 to <18 yr REGN2810 3mg/kg
n=6 Participants
Phase 1 (Cohort D) CNS TUMOR 12 to \<18 yr REGN2810 3mg/kg (Q2W)
|
ndDIPG <12 yr REGN2810 4.5mg/kg + Radiotherapy
Efficacy Phase (Cohort E) ndDIPG \<12 yr REGN2810 4.5mg/kg (Q2W) + Radiotherapy (pre-specified to be assessed regardless of which radiation therapy)
|
ndDIPG >=12 yr REGN2810 3mg/kg + Radiotherapy
Efficacy Phase (Cohort F) ndDIPG \>=12 yr REGN2810 3mg/kg (Q2W) + Radiotherapy (pre-specified to be assessed regardless of which radiation therapy)
|
ndHGG >=12 yr REGN2810 3mg/kg + Radiotherapy
Efficacy Phase (Cohort H) ndHGG \>=12 yr REGN2810 3mg/kg (Q2W) + Radiotherapy (pre-specified to be assessed regardless of which radiation therapy)
|
rHGG <12 yr REGN2810 4.5mg/kg + Re-Irradiation
Efficacy Phase (Cohort I) rHGG \<12 yr REGN2810 4.5mg/kg (Q2W) + Re-Irradiation
|
rHGG >= 12 yr REGN2810 3mg/kg + Re-Irradiation
Efficacy Phase (Cohort J) rHGG \>= 12 yr REGN2810 3mg/kg (Q2W) + Re-Irradiation
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Developed DLTs (Efficacy Phase)
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 24 monthsPopulation: Cohorts used for pharmacokinetic endpoints were based on age and/or tumor type. Radiation type was collected, but not used for assessment; Due to sparse sampling, elimination half-life could not be calculated.
Outcome measures
| Measure |
SOLID TUMOR < 12 yr REGN2810 3mg/kg
n=3 Participants
Phase 1 (Cohort A) SOLID TUMOR \< 12 yr REGN2810 3 milligrams/kilogram (mg/kg) every two weeks (Q2W)
|
SOLID TUMOR 12 to <18 yr REGN2810 3mg/kg
n=5 Participants
Phase 1 (Cohort B) SOLID TUMOR 12 to \<18 yr REGN2810 3mg/kg (Q2W)
|
CNS TUMOR <12 yr REGN2810 3mg/kg
n=3 Participants
Phase 1 (Cohort C1) Central Nervous System (CNS) TUMOR \<12 yr REGN2810 3mg/kg (Q2W)
|
CNS TUMOR <12 yr REGN2810 4.5mg/kg
n=9 Participants
Phase 1 (Cohort C2) CNS TUMOR \<12 yr REGN2810 4.5mg/kg (Q2W)
|
CNS TUMOR 12 to <18 yr REGN2810 3mg/kg
n=5 Participants
Phase 1 (Cohort D) CNS TUMOR 12 to \<18 yr REGN2810 3mg/kg (Q2W)
|
ndDIPG <12 yr REGN2810 4.5mg/kg + Radiotherapy
n=6 Participants
Efficacy Phase (Cohort E) ndDIPG \<12 yr REGN2810 4.5mg/kg (Q2W) + Radiotherapy (pre-specified to be assessed regardless of which radiation therapy)
|
ndDIPG >=12 yr REGN2810 3mg/kg + Radiotherapy
n=4 Participants
Efficacy Phase (Cohort F) ndDIPG \>=12 yr REGN2810 3mg/kg (Q2W) + Radiotherapy (pre-specified to be assessed regardless of which radiation therapy)
|
ndHGG >=12 yr REGN2810 3mg/kg + Radiotherapy
n=12 Participants
Efficacy Phase (Cohort H) ndHGG \>=12 yr REGN2810 3mg/kg (Q2W) + Radiotherapy (pre-specified to be assessed regardless of which radiation therapy)
|
rHGG <12 yr REGN2810 4.5mg/kg + Re-Irradiation
n=1 Participants
Efficacy Phase (Cohort I) rHGG \<12 yr REGN2810 4.5mg/kg (Q2W) + Re-Irradiation
|
rHGG >= 12 yr REGN2810 3mg/kg + Re-Irradiation
n=7 Participants
Efficacy Phase (Cohort J) rHGG \>= 12 yr REGN2810 3mg/kg (Q2W) + Re-Irradiation
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Elimination Half-life (t1/2) of Functional Cemiplimab (REGN2810) in Serum
|
NA milligrams/Liter (mg/L)
Due to sparse sampling, elimination half-life could not be calculated.
|
NA milligrams/Liter (mg/L)
Due to sparse sampling, elimination half-life could not be calculated.
|
NA milligrams/Liter (mg/L)
Due to sparse sampling, elimination half-life could not be calculated.
|
NA milligrams/Liter (mg/L)
Due to sparse sampling, elimination half-life could not be calculated.
|
NA milligrams/Liter (mg/L)
Due to sparse sampling, elimination half-life could not be calculated.
|
NA milligrams/Liter (mg/L)
Due to sparse sampling, elimination half-life could not be calculated.
|
NA milligrams/Liter (mg/L)
Due to sparse sampling, elimination half-life could not be calculated.
|
NA milligrams/Liter (mg/L)
Due to sparse sampling, elimination half-life could not be calculated.
|
NA milligrams/Liter (mg/L)
Due to sparse sampling, elimination half-life could not be calculated.
|
NA milligrams/Liter (mg/L)
Due to sparse sampling, elimination half-life could not be calculated.
|
PRIMARY outcome
Timeframe: Up to Week 16Population: Pharmacokinetic Analysis Set (PKAS): All treated participants who received any amount of study drug (SAF) and had at least 1 non-missing functional cemiplimab measurement following the first dose of cemiplimab (based on actual treatment received \[as treated\]); Cohorts used for pharmacokinetic endpoints were based on age and/or tumor type.
Ctrough (trough concentration) of functional cemiplimab in serum reported.
Outcome measures
| Measure |
SOLID TUMOR < 12 yr REGN2810 3mg/kg
n=3 Participants
Phase 1 (Cohort A) SOLID TUMOR \< 12 yr REGN2810 3 milligrams/kilogram (mg/kg) every two weeks (Q2W)
|
SOLID TUMOR 12 to <18 yr REGN2810 3mg/kg
n=5 Participants
Phase 1 (Cohort B) SOLID TUMOR 12 to \<18 yr REGN2810 3mg/kg (Q2W)
|
CNS TUMOR <12 yr REGN2810 3mg/kg
n=3 Participants
Phase 1 (Cohort C1) Central Nervous System (CNS) TUMOR \<12 yr REGN2810 3mg/kg (Q2W)
|
CNS TUMOR <12 yr REGN2810 4.5mg/kg
n=5 Participants
Phase 1 (Cohort C2) CNS TUMOR \<12 yr REGN2810 4.5mg/kg (Q2W)
|
CNS TUMOR 12 to <18 yr REGN2810 3mg/kg
n=9 Participants
Phase 1 (Cohort D) CNS TUMOR 12 to \<18 yr REGN2810 3mg/kg (Q2W)
|
ndDIPG <12 yr REGN2810 4.5mg/kg + Radiotherapy
n=4 Participants
Efficacy Phase (Cohort E) ndDIPG \<12 yr REGN2810 4.5mg/kg (Q2W) + Radiotherapy (pre-specified to be assessed regardless of which radiation therapy)
|
ndDIPG >=12 yr REGN2810 3mg/kg + Radiotherapy
n=12 Participants
Efficacy Phase (Cohort F) ndDIPG \>=12 yr REGN2810 3mg/kg (Q2W) + Radiotherapy (pre-specified to be assessed regardless of which radiation therapy)
|
ndHGG >=12 yr REGN2810 3mg/kg + Radiotherapy
n=7 Participants
Efficacy Phase (Cohort H) ndHGG \>=12 yr REGN2810 3mg/kg (Q2W) + Radiotherapy (pre-specified to be assessed regardless of which radiation therapy)
|
rHGG <12 yr REGN2810 4.5mg/kg + Re-Irradiation
n=6 Participants
Efficacy Phase (Cohort I) rHGG \<12 yr REGN2810 4.5mg/kg (Q2W) + Re-Irradiation
|
rHGG >= 12 yr REGN2810 3mg/kg + Re-Irradiation
n=1 Participants
Efficacy Phase (Cohort J) rHGG \>= 12 yr REGN2810 3mg/kg (Q2W) + Re-Irradiation
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Trough Concentration (Ctrough) of Functional Cemiplimab (REGN2810) in Serum
Ctrough - after 1st dose
|
16.7 mg/L
Interval 14.0 to 16.8
|
23.9 mg/L
Interval 21.1 to 27.2
|
33.8 mg/L
Interval 27.9 to 36.5
|
28.5 mg/L
Interval 19.6 to 42.2
|
48.3 mg/L
Interval 32.9 to 63.8
|
39.7 mg/L
Interval 33.9 to 41.9
|
26.0 mg/L
Interval 17.4 to 36.3
|
36.3 mg/L
Interval 25.2 to 178.0
|
35.8 mg/L
Interval 32.4 to 49.6
|
NA mg/L
Interval 38.5 to 38.5
n=1
|
|
Trough Concentration (Ctrough) of Functional Cemiplimab (REGN2810) in Serum
Ctrough - Week 16 (Cycle 4 Day 1) (4 weeks per cycle)
|
NA mg/L
Interval 39.4 to 39.4
n=1
|
NA mg/L
Interval 78.6 to 78.6
n=1
|
—
|
NA mg/L
Interval 66.1 to 66.1
n=1
|
NA mg/L
Interval 66.1 to 66.1
n=1
|
82.4 mg/L
Interval 65.7 to 104.0
|
94.3 mg/L
Interval 84.5 to 247.0
|
78.5 mg/L
Interval 57.0 to 134.0
|
122 mg/L
Interval 13.1 to 159.0
|
NA mg/L
Interval 70.0 to 70.0
n=1
|
PRIMARY outcome
Timeframe: Up to Week 16Population: Pharmacokinetic Analysis Set (PKAS): All treated participants who received any amount of study drug (SAF) and had at least 1 non-missing functional cemiplimab measurement following the first dose of cemiplimab (based on actual treatment received \[as treated\]); Cohorts used for pharmacokinetic endpoints were based on age and/or tumor type.
Cmax (peak concentration) of functional cemiplimab in serum reported.
Outcome measures
| Measure |
SOLID TUMOR < 12 yr REGN2810 3mg/kg
n=3 Participants
Phase 1 (Cohort A) SOLID TUMOR \< 12 yr REGN2810 3 milligrams/kilogram (mg/kg) every two weeks (Q2W)
|
SOLID TUMOR 12 to <18 yr REGN2810 3mg/kg
n=5 Participants
Phase 1 (Cohort B) SOLID TUMOR 12 to \<18 yr REGN2810 3mg/kg (Q2W)
|
CNS TUMOR <12 yr REGN2810 3mg/kg
n=3 Participants
Phase 1 (Cohort C1) Central Nervous System (CNS) TUMOR \<12 yr REGN2810 3mg/kg (Q2W)
|
CNS TUMOR <12 yr REGN2810 4.5mg/kg
n=5 Participants
Phase 1 (Cohort C2) CNS TUMOR \<12 yr REGN2810 4.5mg/kg (Q2W)
|
CNS TUMOR 12 to <18 yr REGN2810 3mg/kg
n=9 Participants
Phase 1 (Cohort D) CNS TUMOR 12 to \<18 yr REGN2810 3mg/kg (Q2W)
|
ndDIPG <12 yr REGN2810 4.5mg/kg + Radiotherapy
n=4 Participants
Efficacy Phase (Cohort E) ndDIPG \<12 yr REGN2810 4.5mg/kg (Q2W) + Radiotherapy (pre-specified to be assessed regardless of which radiation therapy)
|
ndDIPG >=12 yr REGN2810 3mg/kg + Radiotherapy
n=12 Participants
Efficacy Phase (Cohort F) ndDIPG \>=12 yr REGN2810 3mg/kg (Q2W) + Radiotherapy (pre-specified to be assessed regardless of which radiation therapy)
|
ndHGG >=12 yr REGN2810 3mg/kg + Radiotherapy
n=7 Participants
Efficacy Phase (Cohort H) ndHGG \>=12 yr REGN2810 3mg/kg (Q2W) + Radiotherapy (pre-specified to be assessed regardless of which radiation therapy)
|
rHGG <12 yr REGN2810 4.5mg/kg + Re-Irradiation
n=6 Participants
Efficacy Phase (Cohort I) rHGG \<12 yr REGN2810 4.5mg/kg (Q2W) + Re-Irradiation
|
rHGG >= 12 yr REGN2810 3mg/kg + Re-Irradiation
n=1 Participants
Efficacy Phase (Cohort J) rHGG \>= 12 yr REGN2810 3mg/kg (Q2W) + Re-Irradiation
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Peak Concentration (Cmax) of Functional Cemiplimab (REGN2810) in Serum
Cmax - after 1st dose
|
58.2 mg/L
Interval 52.0 to 86.9
|
73.5 mg/L
Interval 63.4 to 87.9
|
92.2 mg/L
Interval 87.9 to 101.0
|
68.3 mg/L
Interval 60.9 to 101.0
|
152 mg/L
Interval 76.0 to 202.0
|
95.1 mg/L
Interval 65.5 to 106.0
|
71.8 mg/L
Interval 6.41 to 88.0
|
88.8 mg/L
Interval 69.5 to 124.0
|
105 mg/L
Interval 93.7 to 130.0
|
NA mg/L
Interval 123.0 to 123.0
n=1
|
|
Peak Concentration (Cmax) of Functional Cemiplimab (REGN2810) in Serum
Cmax -Week 16 (Cycle 4 Day 1) (4 weeks per cycle)
|
NA mg/L
Interval 122.0 to 122.0
n=1
|
NA mg/L
Interval 136.0 to 136.0
n=1
|
NA mg/L
Interval 112.0 to 112.0
n=1
|
NA mg/L
Interval 112.0 to 112.0
n=1
|
NA mg/L
Interval 236.0 to 236.0
n=1
|
221 mg/L
Interval 164.0 to 256.0
|
165 mg/L
Interval 143.0 to 200.0
|
179 mg/L
Interval 119.0 to 234.0
|
209 mg/L
Interval 99.2 to 297.0
|
NA mg/L
Interval 225.0 to 225.0
n=1
|
PRIMARY outcome
Timeframe: Up to 24 monthsPopulation: Cohorts used for pharmacokinetic endpoints were based on age and/or tumor type; Due to sparse sampling, area under the curve could not be calculated.
Outcome measures
| Measure |
SOLID TUMOR < 12 yr REGN2810 3mg/kg
n=3 Participants
Phase 1 (Cohort A) SOLID TUMOR \< 12 yr REGN2810 3 milligrams/kilogram (mg/kg) every two weeks (Q2W)
|
SOLID TUMOR 12 to <18 yr REGN2810 3mg/kg
n=5 Participants
Phase 1 (Cohort B) SOLID TUMOR 12 to \<18 yr REGN2810 3mg/kg (Q2W)
|
CNS TUMOR <12 yr REGN2810 3mg/kg
n=3 Participants
Phase 1 (Cohort C1) Central Nervous System (CNS) TUMOR \<12 yr REGN2810 3mg/kg (Q2W)
|
CNS TUMOR <12 yr REGN2810 4.5mg/kg
n=5 Participants
Phase 1 (Cohort C2) CNS TUMOR \<12 yr REGN2810 4.5mg/kg (Q2W)
|
CNS TUMOR 12 to <18 yr REGN2810 3mg/kg
n=9 Participants
Phase 1 (Cohort D) CNS TUMOR 12 to \<18 yr REGN2810 3mg/kg (Q2W)
|
ndDIPG <12 yr REGN2810 4.5mg/kg + Radiotherapy
n=4 Participants
Efficacy Phase (Cohort E) ndDIPG \<12 yr REGN2810 4.5mg/kg (Q2W) + Radiotherapy (pre-specified to be assessed regardless of which radiation therapy)
|
ndDIPG >=12 yr REGN2810 3mg/kg + Radiotherapy
n=12 Participants
Efficacy Phase (Cohort F) ndDIPG \>=12 yr REGN2810 3mg/kg (Q2W) + Radiotherapy (pre-specified to be assessed regardless of which radiation therapy)
|
ndHGG >=12 yr REGN2810 3mg/kg + Radiotherapy
n=7 Participants
Efficacy Phase (Cohort H) ndHGG \>=12 yr REGN2810 3mg/kg (Q2W) + Radiotherapy (pre-specified to be assessed regardless of which radiation therapy)
|
rHGG <12 yr REGN2810 4.5mg/kg + Re-Irradiation
n=6 Participants
Efficacy Phase (Cohort I) rHGG \<12 yr REGN2810 4.5mg/kg (Q2W) + Re-Irradiation
|
rHGG >= 12 yr REGN2810 3mg/kg + Re-Irradiation
n=1 Participants
Efficacy Phase (Cohort J) rHGG \>= 12 yr REGN2810 3mg/kg (Q2W) + Re-Irradiation
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve (AUC) of Functional Cemiplimab (REGN2810) in Serum
|
NA mg*hr/L
Due to sparse sampling, area under the curve could not be calculated.
|
NA mg*hr/L
Due to sparse sampling, area under the curve could not be calculated.
|
NA mg*hr/L
Due to sparse sampling, area under the curve could not be calculated.
|
NA mg*hr/L
Due to sparse sampling, area under the curve could not be calculated.
|
NA mg*hr/L
Due to sparse sampling, area under the curve could not be calculated.
|
NA mg*hr/L
Due to sparse sampling, area under the curve could not be calculated.
|
NA mg*hr/L
Due to sparse sampling, area under the curve could not be calculated.
|
NA mg*hr/L
Due to sparse sampling, area under the curve could not be calculated.
|
NA mg*hr/L
Due to sparse sampling, area under the curve could not be calculated.
|
NA mg*hr/L
Due to sparse sampling, area under the curve could not be calculated.
|
PRIMARY outcome
Timeframe: At 12 monthsPopulation: Only participants with newly diagnosed HGG (ndHGG) were assessed for this endpoint.
PFS was defined as the time from randomization to the date of the first documented tumor progression, as determined per Response Assessment in Neuro-Oncology (RANO)/Immunotherapy Response Assessment in Neuro-Oncology (iRANO) criteria, or death due to any cause.
Outcome measures
| Measure |
SOLID TUMOR < 12 yr REGN2810 3mg/kg
n=12 Participants
Phase 1 (Cohort A) SOLID TUMOR \< 12 yr REGN2810 3 milligrams/kilogram (mg/kg) every two weeks (Q2W)
|
SOLID TUMOR 12 to <18 yr REGN2810 3mg/kg
Phase 1 (Cohort B) SOLID TUMOR 12 to \<18 yr REGN2810 3mg/kg (Q2W)
|
CNS TUMOR <12 yr REGN2810 3mg/kg
Phase 1 (Cohort C1) Central Nervous System (CNS) TUMOR \<12 yr REGN2810 3mg/kg (Q2W)
|
CNS TUMOR <12 yr REGN2810 4.5mg/kg
Phase 1 (Cohort C2) CNS TUMOR \<12 yr REGN2810 4.5mg/kg (Q2W)
|
CNS TUMOR 12 to <18 yr REGN2810 3mg/kg
Phase 1 (Cohort D) CNS TUMOR 12 to \<18 yr REGN2810 3mg/kg (Q2W)
|
ndDIPG <12 yr REGN2810 4.5mg/kg + Radiotherapy
Efficacy Phase (Cohort E) ndDIPG \<12 yr REGN2810 4.5mg/kg (Q2W) + Radiotherapy (pre-specified to be assessed regardless of which radiation therapy)
|
ndDIPG >=12 yr REGN2810 3mg/kg + Radiotherapy
Efficacy Phase (Cohort F) ndDIPG \>=12 yr REGN2810 3mg/kg (Q2W) + Radiotherapy (pre-specified to be assessed regardless of which radiation therapy)
|
ndHGG >=12 yr REGN2810 3mg/kg + Radiotherapy
Efficacy Phase (Cohort H) ndHGG \>=12 yr REGN2810 3mg/kg (Q2W) + Radiotherapy (pre-specified to be assessed regardless of which radiation therapy)
|
rHGG <12 yr REGN2810 4.5mg/kg + Re-Irradiation
Efficacy Phase (Cohort I) rHGG \<12 yr REGN2810 4.5mg/kg (Q2W) + Re-Irradiation
|
rHGG >= 12 yr REGN2810 3mg/kg + Re-Irradiation
Efficacy Phase (Cohort J) rHGG \>= 12 yr REGN2810 3mg/kg (Q2W) + Re-Irradiation
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Progression-free Survival (PFS) at 12 Months for Participants With Newly Diagnosed HGG (ndHGG)
|
22.2 Percentage of Participants
Interval 3.4 to 51.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 12 monthsPopulation: Only participants with ndDIPG and recurrent HGG (rHGG) were assessed for this endpoint.
OS was defined as the time from randomization to the date of death due to any cause. A participant who had not died was censored at the last date that participant was documented to be alive. 95% CI is based on Kaplan-Meier method.
Outcome measures
| Measure |
SOLID TUMOR < 12 yr REGN2810 3mg/kg
n=6 Participants
Phase 1 (Cohort A) SOLID TUMOR \< 12 yr REGN2810 3 milligrams/kilogram (mg/kg) every two weeks (Q2W)
|
SOLID TUMOR 12 to <18 yr REGN2810 3mg/kg
n=5 Participants
Phase 1 (Cohort B) SOLID TUMOR 12 to \<18 yr REGN2810 3mg/kg (Q2W)
|
CNS TUMOR <12 yr REGN2810 3mg/kg
n=1 Participants
Phase 1 (Cohort C1) Central Nervous System (CNS) TUMOR \<12 yr REGN2810 3mg/kg (Q2W)
|
CNS TUMOR <12 yr REGN2810 4.5mg/kg
n=8 Participants
Phase 1 (Cohort C2) CNS TUMOR \<12 yr REGN2810 4.5mg/kg (Q2W)
|
CNS TUMOR 12 to <18 yr REGN2810 3mg/kg
Phase 1 (Cohort D) CNS TUMOR 12 to \<18 yr REGN2810 3mg/kg (Q2W)
|
ndDIPG <12 yr REGN2810 4.5mg/kg + Radiotherapy
Efficacy Phase (Cohort E) ndDIPG \<12 yr REGN2810 4.5mg/kg (Q2W) + Radiotherapy (pre-specified to be assessed regardless of which radiation therapy)
|
ndDIPG >=12 yr REGN2810 3mg/kg + Radiotherapy
Efficacy Phase (Cohort F) ndDIPG \>=12 yr REGN2810 3mg/kg (Q2W) + Radiotherapy (pre-specified to be assessed regardless of which radiation therapy)
|
ndHGG >=12 yr REGN2810 3mg/kg + Radiotherapy
Efficacy Phase (Cohort H) ndHGG \>=12 yr REGN2810 3mg/kg (Q2W) + Radiotherapy (pre-specified to be assessed regardless of which radiation therapy)
|
rHGG <12 yr REGN2810 4.5mg/kg + Re-Irradiation
Efficacy Phase (Cohort I) rHGG \<12 yr REGN2810 4.5mg/kg (Q2W) + Re-Irradiation
|
rHGG >= 12 yr REGN2810 3mg/kg + Re-Irradiation
Efficacy Phase (Cohort J) rHGG \>= 12 yr REGN2810 3mg/kg (Q2W) + Re-Irradiation
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Overall Survival (OS) at 12 Months for Participants With ndDIPG and Recurrent HGG (rHGG)
|
0.0 Percentage of Participants
NA = Insufficient number of participants with events
|
40.0 Percentage of Participants
Interval 5.2 to 75.3
|
0.0 Percentage of Participants
NA = Insufficient number of participants with events
|
35.7 Percentage of Participants
Interval 5.2 to 69.9
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Approximately 24 monthsORR was defined as the percentage of participants who have a confirmed complete response (CR) or partial response (PR), as determined per standard criteria between the date of first study treatment and the date of the first objectively documented progression or the date of receiving another anti-cancer systemic therapy, whichever came first. Clopper-Person exact confidence interval
Outcome measures
| Measure |
SOLID TUMOR < 12 yr REGN2810 3mg/kg
n=3 Participants
Phase 1 (Cohort A) SOLID TUMOR \< 12 yr REGN2810 3 milligrams/kilogram (mg/kg) every two weeks (Q2W)
|
SOLID TUMOR 12 to <18 yr REGN2810 3mg/kg
n=5 Participants
Phase 1 (Cohort B) SOLID TUMOR 12 to \<18 yr REGN2810 3mg/kg (Q2W)
|
CNS TUMOR <12 yr REGN2810 3mg/kg
n=3 Participants
Phase 1 (Cohort C1) Central Nervous System (CNS) TUMOR \<12 yr REGN2810 3mg/kg (Q2W)
|
CNS TUMOR <12 yr REGN2810 4.5mg/kg
n=9 Participants
Phase 1 (Cohort C2) CNS TUMOR \<12 yr REGN2810 4.5mg/kg (Q2W)
|
CNS TUMOR 12 to <18 yr REGN2810 3mg/kg
n=5 Participants
Phase 1 (Cohort D) CNS TUMOR 12 to \<18 yr REGN2810 3mg/kg (Q2W)
|
ndDIPG <12 yr REGN2810 4.5mg/kg + Radiotherapy
n=6 Participants
Efficacy Phase (Cohort E) ndDIPG \<12 yr REGN2810 4.5mg/kg (Q2W) + Radiotherapy (pre-specified to be assessed regardless of which radiation therapy)
|
ndDIPG >=12 yr REGN2810 3mg/kg + Radiotherapy
n=5 Participants
Efficacy Phase (Cohort F) ndDIPG \>=12 yr REGN2810 3mg/kg (Q2W) + Radiotherapy (pre-specified to be assessed regardless of which radiation therapy)
|
ndHGG >=12 yr REGN2810 3mg/kg + Radiotherapy
n=12 Participants
Efficacy Phase (Cohort H) ndHGG \>=12 yr REGN2810 3mg/kg (Q2W) + Radiotherapy (pre-specified to be assessed regardless of which radiation therapy)
|
rHGG <12 yr REGN2810 4.5mg/kg + Re-Irradiation
n=1 Participants
Efficacy Phase (Cohort I) rHGG \<12 yr REGN2810 4.5mg/kg (Q2W) + Re-Irradiation
|
rHGG >= 12 yr REGN2810 3mg/kg + Re-Irradiation
n=8 Participants
Efficacy Phase (Cohort J) rHGG \>= 12 yr REGN2810 3mg/kg (Q2W) + Re-Irradiation
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Objective Response Rate (ORR) for Participants Who Have a Confirmed Complete Response (CR) or Partial Response (PR)
|
0 Percentage of Participants
Interval 0.0 to 70.8
|
0 Percentage of Participants
Interval 0.0 to 52.2
|
0 Percentage of Participants
Interval 0.0 to 70.8
|
0 Percentage of Participants
Interval 0.0 to 33.6
|
0 Percentage of Participants
Interval 0.0 to 52.2
|
0 Percentage of Participants
Interval 0.0 to 45.9
|
0 Percentage of Participants
Interval 0.0 to 52.2
|
8.3 Percentage of Participants
Interval 0.2 to 38.5
|
0 Percentage of Participants
Interval 0.0 to 97.5
|
0 Percentage of Participants
Interval 0.0 to 36.9
|
SECONDARY outcome
Timeframe: 1st follow-up visit, approximately 25 monthsPopulation: ADA analysis set (AAS): all treated participants who received any amount of cemiplimab (SAF) \& had ≥1 non-missing ADA result following first dose of cemiplimab (based on actual treatment received \[as treated\]). By design, the study arms were expected to be reflective of tumor type/diagnosis
ADA status classified as: Positive; Pre-existing (baseline \[BL\] sample positive \& all post BL ADA titers reported as \< 9-fold BL titer value); Negative (all samples negative); ADA positive: Treatment-boosted (positive result at BL with ≥1 post BL titer result ≥9-fold BL titer value); Treatment-emergent (TE) (negative result or missing result at BL with ≥1 positive post BL result); TE: Persistent (positive result detected in ≥2 consecutive post BL samples separated by ≥ a 12/16-week post BL period with no ADA-negative results in-between, regardless of any missing samples; Indeterminate (positive result in last collection, regardless of any missing samples); Transient (not persistent or indeterminate, regardless of any missing samples)
Outcome measures
| Measure |
SOLID TUMOR < 12 yr REGN2810 3mg/kg
n=16 Participants
Phase 1 (Cohort A) SOLID TUMOR \< 12 yr REGN2810 3 milligrams/kilogram (mg/kg) every two weeks (Q2W)
|
SOLID TUMOR 12 to <18 yr REGN2810 3mg/kg
n=5 Participants
Phase 1 (Cohort B) SOLID TUMOR 12 to \<18 yr REGN2810 3mg/kg (Q2W)
|
CNS TUMOR <12 yr REGN2810 3mg/kg
n=19 Participants
Phase 1 (Cohort C1) Central Nervous System (CNS) TUMOR \<12 yr REGN2810 3mg/kg (Q2W)
|
CNS TUMOR <12 yr REGN2810 4.5mg/kg
n=7 Participants
Phase 1 (Cohort C2) CNS TUMOR \<12 yr REGN2810 4.5mg/kg (Q2W)
|
CNS TUMOR 12 to <18 yr REGN2810 3mg/kg
Phase 1 (Cohort D) CNS TUMOR 12 to \<18 yr REGN2810 3mg/kg (Q2W)
|
ndDIPG <12 yr REGN2810 4.5mg/kg + Radiotherapy
Efficacy Phase (Cohort E) ndDIPG \<12 yr REGN2810 4.5mg/kg (Q2W) + Radiotherapy (pre-specified to be assessed regardless of which radiation therapy)
|
ndDIPG >=12 yr REGN2810 3mg/kg + Radiotherapy
Efficacy Phase (Cohort F) ndDIPG \>=12 yr REGN2810 3mg/kg (Q2W) + Radiotherapy (pre-specified to be assessed regardless of which radiation therapy)
|
ndHGG >=12 yr REGN2810 3mg/kg + Radiotherapy
Efficacy Phase (Cohort H) ndHGG \>=12 yr REGN2810 3mg/kg (Q2W) + Radiotherapy (pre-specified to be assessed regardless of which radiation therapy)
|
rHGG <12 yr REGN2810 4.5mg/kg + Re-Irradiation
Efficacy Phase (Cohort I) rHGG \<12 yr REGN2810 4.5mg/kg (Q2W) + Re-Irradiation
|
rHGG >= 12 yr REGN2810 3mg/kg + Re-Irradiation
Efficacy Phase (Cohort J) rHGG \>= 12 yr REGN2810 3mg/kg (Q2W) + Re-Irradiation
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Anti-REGN2810 Antibodies (ADA)
Negative
|
16 Participants
|
5 Participants
|
17 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Anti-REGN2810 Antibodies (ADA)
Pre-existing immunoreactivity
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Anti-REGN2810 Antibodies (ADA)
Treatment-emergent (TE) response
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
SOLID TUMOR < 12 yr REGN2810 3mg/kg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 2 deaths
SOLID TUMOR 12 to <18 yr REGN2810 3mg/kg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 4 deaths
CNS TUMOR <12 yr REGN2810 3mg/kg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 2 deaths
CNS TUMOR <12 yr REGN2810 4.5mg/kg
Serious events: 3 serious events
Other events: 8 other events
Deaths: 8 deaths
CNS TUMOR 12 to <18 yr REGN2810 3mg/kg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 3 deaths
ndDIPG <12 yr REGN2810 4.5mg/kg + Radiotherapy
Serious events: 3 serious events
Other events: 6 other events
Deaths: 6 deaths
ndDIPG >=12 yr REGN2810 3mg/kg + Radiotherapy
Serious events: 3 serious events
Other events: 5 other events
Deaths: 4 deaths
ndHGG >=12 yr REGN2810 3mg/kg + Radiotherapy
Serious events: 7 serious events
Other events: 12 other events
Deaths: 7 deaths
rHGG <12 yr REGN2810 4.5mg/kg + Re-Irradiation
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
rHGG >= 12 yr REGN2810 3mg/kg + Re-Irradiation
Serious events: 5 serious events
Other events: 8 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
SOLID TUMOR < 12 yr REGN2810 3mg/kg
n=3 participants at risk
Phase 1 (Cohort A) SOLID TUMOR \< 12 yr REGN2810 3 milligrams/kilogram (mg/kg) every two weeks (Q2W)
|
SOLID TUMOR 12 to <18 yr REGN2810 3mg/kg
n=5 participants at risk
Phase 1 SOLID TUMOR 12 to \<18 yr REGN2810 3mg/kg (Q2W)
|
CNS TUMOR <12 yr REGN2810 3mg/kg
n=3 participants at risk
Phase 1 CNS TUMOR \<12 yr REGN2810 3mg/kg (Q2W)
|
CNS TUMOR <12 yr REGN2810 4.5mg/kg
n=9 participants at risk
Phase 1 CNS TUMOR \<12 yr REGN2810 4.5mg/kg (Q2W)
|
CNS TUMOR 12 to <18 yr REGN2810 3mg/kg
n=5 participants at risk
Phase 1 CNS TUMOR 12 to \<18 yr REGN2810 3mg/kg (Q2W)
|
ndDIPG <12 yr REGN2810 4.5mg/kg + Radiotherapy
n=6 participants at risk
Efficacy Phase (Cohort E) ndDIPG \<12 yr REGN2810 4.5mg/kg (Q2W) + Radiotherapy (pre-specified to be assessed regardless of which radiation therapy)
|
ndDIPG >=12 yr REGN2810 3mg/kg + Radiotherapy
n=5 participants at risk
Efficacy Phase (Cohort F) ndDIPG \>=12 yr REGN2810 3mg/kg (Q2W) + Radiotherapy (pre-specified to be assessed regardless of which radiation therapy)
|
ndHGG >=12 yr REGN2810 3mg/kg + Radiotherapy
n=12 participants at risk
Efficacy Phase (Cohort H) ndHGG \>=12 yr REGN2810 3mg/kg (Q2W) + Radiotherapy (pre-specified to be assessed regardless of which radiation therapy)
|
rHGG <12 yr REGN2810 4.5mg/kg + Re-Irradiation
n=1 participants at risk
Efficacy Phase (Cohort I) rHGG \<12 yr REGN2810 4.5mg/kg (Q2W) + Re-Irradiation
|
rHGG >= 12 yr REGN2810 3mg/kg + Re-Irradiation
n=8 participants at risk
Efficacy Phase rHGG \>= 12 yr REGN2810 3mg/kg (Q2W) + Re-Irradiation
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
11.1%
1/9 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
11.1%
1/9 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
11.1%
1/9 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
16.7%
1/6 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
11.1%
1/9 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Infections and infestations
Device related infection
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
16.7%
1/6 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Infections and infestations
Encephalitis
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Infections and infestations
Meningitis
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
16.7%
1/6 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
General disorders
Pyrexia
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Injury, poisoning and procedural complications
Foreign body ingestion
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
16.7%
1/6 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Investigations
Weight decreased
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
16.7%
1/6 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
16.7%
1/6 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pseudoprogression
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
33.3%
2/6 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Nervous system disorders
IIIrd nerve disorder
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Nervous system disorders
Nervous system disorder
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Nervous system disorders
Seizure
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
16.7%
2/12 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
16.7%
1/6 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Skin and subcutaneous tissue disorders
Drug reaction with eosinophilia and systemic symptoms
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Social circumstances
Family stress
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
16.7%
1/6 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
Other adverse events
| Measure |
SOLID TUMOR < 12 yr REGN2810 3mg/kg
n=3 participants at risk
Phase 1 (Cohort A) SOLID TUMOR \< 12 yr REGN2810 3 milligrams/kilogram (mg/kg) every two weeks (Q2W)
|
SOLID TUMOR 12 to <18 yr REGN2810 3mg/kg
n=5 participants at risk
Phase 1 SOLID TUMOR 12 to \<18 yr REGN2810 3mg/kg (Q2W)
|
CNS TUMOR <12 yr REGN2810 3mg/kg
n=3 participants at risk
Phase 1 CNS TUMOR \<12 yr REGN2810 3mg/kg (Q2W)
|
CNS TUMOR <12 yr REGN2810 4.5mg/kg
n=9 participants at risk
Phase 1 CNS TUMOR \<12 yr REGN2810 4.5mg/kg (Q2W)
|
CNS TUMOR 12 to <18 yr REGN2810 3mg/kg
n=5 participants at risk
Phase 1 CNS TUMOR 12 to \<18 yr REGN2810 3mg/kg (Q2W)
|
ndDIPG <12 yr REGN2810 4.5mg/kg + Radiotherapy
n=6 participants at risk
Efficacy Phase (Cohort E) ndDIPG \<12 yr REGN2810 4.5mg/kg (Q2W) + Radiotherapy (pre-specified to be assessed regardless of which radiation therapy)
|
ndDIPG >=12 yr REGN2810 3mg/kg + Radiotherapy
n=5 participants at risk
Efficacy Phase (Cohort F) ndDIPG \>=12 yr REGN2810 3mg/kg (Q2W) + Radiotherapy (pre-specified to be assessed regardless of which radiation therapy)
|
ndHGG >=12 yr REGN2810 3mg/kg + Radiotherapy
n=12 participants at risk
Efficacy Phase (Cohort H) ndHGG \>=12 yr REGN2810 3mg/kg (Q2W) + Radiotherapy (pre-specified to be assessed regardless of which radiation therapy)
|
rHGG <12 yr REGN2810 4.5mg/kg + Re-Irradiation
n=1 participants at risk
Efficacy Phase (Cohort I) rHGG \<12 yr REGN2810 4.5mg/kg (Q2W) + Re-Irradiation
|
rHGG >= 12 yr REGN2810 3mg/kg + Re-Irradiation
n=8 participants at risk
Efficacy Phase rHGG \>= 12 yr REGN2810 3mg/kg (Q2W) + Re-Irradiation
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Nervous system disorders
Hypoglossal nerve disorder
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Nervous system disorders
IIIrd nerve disorder
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
16.7%
1/6 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Nervous system disorders
Lethargy
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
33.3%
2/6 • Number of events 3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
16.7%
2/12 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
100.0%
1/1 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
33.3%
1/3 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
33.3%
3/9 • Number of events 4 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
40.0%
2/5 • Number of events 3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
16.7%
2/12 • Number of events 4 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
100.0%
1/1 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
66.7%
2/3 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
66.7%
2/3 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
50.0%
3/6 • Number of events 3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
40.0%
2/5 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
8.3%
1/12 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
37.5%
3/8 • Number of events 4 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
22.2%
2/9 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
33.3%
2/6 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
33.3%
1/3 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
11.1%
1/9 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
16.7%
1/6 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
33.3%
4/12 • Number of events 6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
100.0%
1/1 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
12.5%
1/8 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
11.1%
1/9 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
12.5%
1/8 • Number of events 3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
11.1%
1/9 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Metabolism and nutrition disorders
Alkalosis
|
33.3%
1/3 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
40.0%
2/5 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
16.7%
2/12 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
100.0%
1/1 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
12.5%
1/8 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
12.5%
1/8 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
16.7%
1/6 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
25.0%
2/8 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
100.0%
1/1 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
12.5%
1/8 • Number of events 4 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
8.3%
1/12 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
100.0%
1/1 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
25.0%
2/8 • Number of events 5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
100.0%
1/1 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
16.7%
1/6 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
16.7%
2/12 • Number of events 4 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
100.0%
1/1 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
33.3%
1/3 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
11.1%
1/9 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
40.0%
2/5 • Number of events 4 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
50.0%
3/6 • Number of events 7 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
40.0%
2/5 • Number of events 3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
50.0%
6/12 • Number of events 7 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
11.1%
1/9 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
33.3%
2/6 • Number of events 3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
40.0%
2/5 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
62.5%
5/8 • Number of events 6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Gastrointestinal disorders
Nausea
|
66.7%
2/3 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
33.3%
1/3 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
60.0%
3/5 • Number of events 3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
50.0%
6/12 • Number of events 10 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
50.0%
4/8 • Number of events 6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
11.1%
1/9 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
50.0%
3/6 • Number of events 3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
12.5%
1/8 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
100.0%
1/1 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Gastrointestinal disorders
Anal incontinence
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
16.7%
1/6 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
16.7%
1/6 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
1/3 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
33.3%
2/6 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
16.7%
1/6 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
General disorders
Fatigue
|
33.3%
1/3 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
33.3%
1/3 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
22.2%
2/9 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
80.0%
4/5 • Number of events 5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
16.7%
1/6 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
40.0%
2/5 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
50.0%
6/12 • Number of events 8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
100.0%
1/1 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
75.0%
6/8 • Number of events 8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
General disorders
Pyrexia
|
33.3%
1/3 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
33.3%
1/3 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
16.7%
1/6 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
25.0%
3/12 • Number of events 4 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
100.0%
1/1 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
12.5%
1/8 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
General disorders
Catheter site pain
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
11.1%
1/9 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
General disorders
Face oedema
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
General disorders
Pain
|
33.3%
1/3 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
33.3%
1/3 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
General disorders
Asthenia
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
General disorders
Chest pain
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
16.7%
2/12 • Number of events 3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
General disorders
Chills
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
General disorders
Gait disturbance
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
25.0%
2/8 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
General disorders
Peripheral swelling
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
66.7%
2/3 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
11.1%
1/9 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
40.0%
2/5 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
33.3%
1/3 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
11.1%
1/9 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
40.0%
2/5 • Number of events 3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
33.3%
2/6 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
60.0%
3/5 • Number of events 7 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
41.7%
5/12 • Number of events 10 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
50.0%
4/8 • Number of events 4 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Nervous system disorders
Seizure
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
40.0%
2/5 • Number of events 4 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
25.0%
3/12 • Number of events 3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
25.0%
2/8 • Number of events 3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Nervous system disorders
Accessory nerve disorder
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
11.1%
1/9 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
11.1%
1/9 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
25.0%
2/8 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Nervous system disorders
Facial nerve disorder
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
16.7%
1/6 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
16.7%
2/12 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
11.1%
1/9 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
12.5%
1/8 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Nervous system disorders
Tremor
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
25.0%
2/8 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Nervous system disorders
Aphasia
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
25.0%
2/8 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Nervous system disorders
Ataxia
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
50.0%
3/6 • Number of events 3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Nervous system disorders
Auditory nerve disorder
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Nervous system disorders
Autonomic nervous system imbalance
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
16.7%
1/6 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Nervous system disorders
Central nervous system necrosis
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
16.7%
1/6 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Nervous system disorders
Dysmetria
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Nervous system disorders
Glossopharyngeal nerve disorder
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
33.3%
2/6 • Number of events 3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
16.7%
1/6 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Nervous system disorders
Muscle spasticity
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
16.7%
1/6 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Nervous system disorders
Nystagmus
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Nervous system disorders
Trigeminal nerve disorder
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
40.0%
2/5 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Nervous system disorders
VIth nerve disorder
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
16.7%
1/6 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Investigations
Lipase increased
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
22.2%
2/9 • Number of events 3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
100.0%
1/1 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
11.1%
1/9 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
16.7%
1/6 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
40.0%
2/5 • Number of events 7 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
8.3%
1/12 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
100.0%
1/1 • Number of events 3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
25.0%
2/8 • Number of events 5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
1/3 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
11.1%
1/9 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
60.0%
3/5 • Number of events 5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
100.0%
1/1 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
22.2%
2/9 • Number of events 3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
16.7%
2/12 • Number of events 4 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
12.5%
1/8 • Number of events 4 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
16.7%
1/6 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Investigations
Lymphocyte count decreased
|
33.3%
1/3 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
40.0%
2/5 • Number of events 3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
11.1%
1/9 • Number of events 3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
50.0%
3/6 • Number of events 4 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
16.7%
2/12 • Number of events 8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
100.0%
1/1 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
37.5%
3/8 • Number of events 6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Investigations
Weight decreased
|
33.3%
1/3 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
11.1%
1/9 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
16.7%
1/6 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Investigations
Weight increased
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Investigations
Amylase increased
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
16.7%
1/6 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
40.0%
2/5 • Number of events 3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
16.7%
1/6 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Investigations
Blood bicarbonate decreased
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
40.0%
2/5 • Number of events 3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
16.7%
1/6 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
25.0%
2/8 • Number of events 5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Investigations
Blood thyroid stimulating hormone decreased
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
16.7%
1/6 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
8.3%
1/12 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Investigations
C-reactive protein increased
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Investigations
Haemoglobin increased
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
16.7%
1/6 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
8.3%
1/12 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
16.7%
1/6 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
100.0%
1/1 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
25.0%
2/8 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
100.0%
1/1 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
25.0%
2/8 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Investigations
Protein total decreased
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
16.7%
2/12 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Investigations
White blood cell count decreased
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
33.3%
2/6 • Number of events 3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
33.3%
4/12 • Number of events 7 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
100.0%
1/1 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
37.5%
3/8 • Number of events 4 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
11.1%
1/9 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
40.0%
2/5 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
16.7%
2/12 • Number of events 3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
11.1%
1/9 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
16.7%
1/6 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
8.3%
1/12 • Number of events 4 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
25.0%
2/8 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
40.0%
2/5 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
11.1%
1/9 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
25.0%
2/8 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
11.1%
1/9 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
11.1%
1/9 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
60.0%
3/5 • Number of events 4 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
8.3%
1/12 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
66.7%
2/3 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
33.3%
2/6 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
11.1%
1/9 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
16.7%
1/6 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
33.3%
1/3 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
33.3%
1/3 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
33.3%
1/3 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
33.3%
1/3 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
33.3%
2/6 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
40.0%
2/5 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
16.7%
1/6 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal ulceration
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Respiratory, thoracic and mediastinal disorders
Respiration abnormal
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
100.0%
1/1 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
40.0%
2/5 • Number of events 3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
16.7%
1/6 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
60.0%
3/5 • Number of events 5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
11.1%
1/9 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
16.7%
1/6 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
25.0%
3/12 • Number of events 3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
100.0%
1/1 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
22.2%
2/9 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Blood and lymphatic system disorders
Neutrophilia
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
11.1%
1/9 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
8.3%
1/12 • Number of events 5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
33.3%
1/3 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
16.7%
2/12 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
11.1%
1/9 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Infections and infestations
Skin infection
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
33.3%
1/3 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
16.7%
1/6 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
33.3%
1/3 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
16.7%
1/6 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
16.7%
2/12 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
11.1%
1/9 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Infections and infestations
COVID-19
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
16.7%
1/6 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
16.7%
1/6 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Infections and infestations
Skin candida
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
16.7%
1/6 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
16.7%
1/6 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
40.0%
2/5 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
16.7%
1/6 • Number of events 3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
11.1%
1/9 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
33.3%
2/6 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Injury, poisoning and procedural complications
Abdominal wound dehiscence
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
16.7%
1/6 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
12.5%
1/8 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Injury, poisoning and procedural complications
Incision site erythema
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
16.7%
1/6 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
50.0%
3/6 • Number of events 4 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
100.0%
1/1 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Injury, poisoning and procedural complications
Procedural site reaction
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Injury, poisoning and procedural complications
Pseudomeningocele
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Injury, poisoning and procedural complications
Stoma site pain
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
16.7%
1/6 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
11.1%
1/9 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
66.7%
8/12 • Number of events 9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
16.7%
2/12 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
11.1%
1/9 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
16.7%
2/12 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
11.1%
1/9 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
16.7%
1/6 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
16.7%
1/6 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
16.7%
1/6 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
8.3%
1/12 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
40.0%
2/5 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
16.7%
1/6 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
16.7%
2/12 • Number of events 3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Skin and subcutaneous tissue disorders
Skin atrophy
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
16.7%
2/12 • Number of events 3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
11.1%
1/9 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
16.7%
2/12 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
33.3%
1/3 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
8.3%
1/12 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Cardiac disorders
Diastolic dysfunction
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Cardiac disorders
Palpitations
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
8.3%
1/12 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Eye disorders
Dry eye
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
11.1%
1/9 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
16.7%
1/6 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
33.3%
1/3 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Eye disorders
Optic atrophy
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
11.1%
1/9 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Eye disorders
Conjunctival hyperaemia
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Eye disorders
Diplopia
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Eye disorders
Eyelid function disorder
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
16.7%
1/6 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Eye disorders
Papilloedema
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
12.5%
1/8 • Number of events 4 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Eye disorders
Photophobia
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Eye disorders
Pupillary reflex impaired
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
16.7%
1/6 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Eye disorders
Vision blurred
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
12.5%
1/8 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Eye disorders
Visual impairment
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
33.3%
1/3 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Psychiatric disorders
Personality change
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
33.3%
1/3 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
11.1%
1/9 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
16.7%
2/12 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
25.0%
3/12 • Number of events 3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Psychiatric disorders
Irritability
|
33.3%
1/3 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
16.7%
1/6 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pseudoprogression
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
11.1%
1/9 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
16.7%
1/6 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
40.0%
2/5 • Number of events 3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
16.7%
2/12 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
100.0%
1/1 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
25.0%
2/8 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intracranial tumour haemorrhage
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
11.1%
1/9 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
16.7%
1/6 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
12.5%
1/8 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
33.3%
1/3 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Vascular disorders
Flushing
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
100.0%
1/1 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Vascular disorders
Haematoma
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
8.3%
1/12 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Ear and labyrinth disorders
External ear pain
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
16.7%
1/6 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
16.7%
1/6 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Endocrine disorders
Cushingoid
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
16.7%
2/12 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
37.5%
3/8 • Number of events 5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
20.0%
1/5 • Number of events 2 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Reproductive system and breast disorders
Heavy menstrual bleeding
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/6 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
8.3%
1/12 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
|
Social circumstances
Family stress
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/3 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/9 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
16.7%
1/6 • Number of events 1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/5 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/12 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/1 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
0.00%
0/8 • From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
|
Additional Information
Clinical Trials Administrator
Regeneron Pharmaceuticals Inc.
Phone: 844-734-6643
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator has the right to independently publish study results from the investigator's site after a multi-center publication, or a defined period after the completion of the study by all sites. The investigator must provide the sponsor a copy of any such publication derived from the study for review and comment in advance of any submission, and delay publication, if requested, to allow the Sponsor to preserve its proprietary rights.
- Publication restrictions are in place
Restriction type: OTHER