Trial Outcomes & Findings for MSB0011359C (M7824) in Metastatic or Locally Advanced Solid Tumors (NCT NCT02517398)
NCT ID: NCT02517398
Last Updated: 2024-05-03
Results Overview
Adverse event (AE): any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. Serious AE: an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAE: AE with onset after start of treatment or with onset date before the treatment start date but worsening after the treatment start date. TEAEs included both serious and non-serious TEAEs.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
600 participants
Primary outcome timeframe
From start of study drug administration up to 139 weeks
Results posted on
2024-05-03
Participant Flow
A total of 600 participants were enrolled, randomised and received treatment with M7824 (Bintrafusp alfa).Out of which, 45 participants were included in dose-escalation part at each dose level depending on the occurrence of dose-limiting toxicities and 555 participants in consecutive parallel-group dose-expansion part in selected solid tumor indications.
Participant milestones
| Measure |
Dose-escalation: M7824 0.3 - 10 mg/kg
Participants received a dose of 0.3 milligram per kilogram (mg/kg) M7824 intravenous (IV) infusion as a first dose and then switched to a 10 mg/kg as a second dose over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or investigational medicinal product (IMP) occurs.
|
Dose-escalation: M7824 1 mg/kg
Participants received a dose of 1 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 1 - 1200 mg
Participants received IV infusion of M7824 1 mg/kg over 1 hour as first dose switched to a 1200 milligram per infusion (mg/infusion) over 1 hour as second dose once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 3 mg/kg
Participants received a dose of 3 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 10 mg/kg
Participants received a dose of 10 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 20 mg/kg
Participants received a dose of 20 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 30 mg/kg
Participants received a dose of 30 mg/kg M7824 IV infusion over 2 hours once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 2400 mg/Infusion
Participants received a flat dose of 2400 mg/infusion M7824 IV infusion over 2 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: HCC-3 mg/kg
Participants with Hepatocellular carcinoma (HCC) received a dose of 3 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: HCC Ascending Dose 1200mg
Subjects with HCC received a flat ascending dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: HCC-2L
Subjects with HCC-2L received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Melanoma PD-L1 Fail
Participants with Melanoma prior programmed death ligand-1 treatment failure (Melanoma PD-L1 Fail) received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC PD-L1 Fail
Participants with Non-small Cell Lung Cancer (NSCLC) PD-L1 Fail (must have received and failed platinum-based chemotherapy and must have received anti-PD-1 or anti-PD-L1 as monotherapy and failed with disease progression) received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Pancreatic Adenocarcinoma
Participants with Pancreatic Adenocarcinoma received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Esophageal Adenocarcinoma
Participants with Esophageal Adenocarcinoma received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Colorectal Carcinoma
Participants with Colorectal Carcinoma received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Triple Negative Breast Cancer
Participants with Triple Negative Breast Cancer received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Glioblastoma
Participants with Glioblastoma received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Squamous Cell Carcinoma of Head and Neck
Participants with Squamous Cell Carcinoma of Head and Neck received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Cervical Cancer
Participants with Cervical Cancer received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC-2L 1200 mg
Participants with NSCLC second line (NSCLC-2L) received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC-2L 500 mg
Participants with NSCLC-2L received a flat dose of 500 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC Biomarker
Participants with NSCLC Biomarker (who were naïve to the anti-PD-1/anti-PD-L1 class and had relapsed, refractory, or PD following an anti-PD-1 or anti-PD-L1 agent) received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
4
|
3
|
6
|
10
|
7
|
3
|
6
|
38
|
68
|
32
|
83
|
36
|
30
|
32
|
33
|
35
|
32
|
15
|
40
|
40
|
41
|
|
Overall Study
COMPLETED
|
1
|
0
|
0
|
0
|
3
|
2
|
3
|
1
|
0
|
10
|
8
|
4
|
3
|
2
|
1
|
2
|
2
|
5
|
6
|
5
|
4
|
7
|
18
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
4
|
3
|
3
|
8
|
4
|
2
|
6
|
28
|
60
|
28
|
80
|
34
|
29
|
30
|
31
|
30
|
26
|
10
|
36
|
33
|
23
|
Reasons for withdrawal
| Measure |
Dose-escalation: M7824 0.3 - 10 mg/kg
Participants received a dose of 0.3 milligram per kilogram (mg/kg) M7824 intravenous (IV) infusion as a first dose and then switched to a 10 mg/kg as a second dose over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or investigational medicinal product (IMP) occurs.
|
Dose-escalation: M7824 1 mg/kg
Participants received a dose of 1 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 1 - 1200 mg
Participants received IV infusion of M7824 1 mg/kg over 1 hour as first dose switched to a 1200 milligram per infusion (mg/infusion) over 1 hour as second dose once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 3 mg/kg
Participants received a dose of 3 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 10 mg/kg
Participants received a dose of 10 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 20 mg/kg
Participants received a dose of 20 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 30 mg/kg
Participants received a dose of 30 mg/kg M7824 IV infusion over 2 hours once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 2400 mg/Infusion
Participants received a flat dose of 2400 mg/infusion M7824 IV infusion over 2 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: HCC-3 mg/kg
Participants with Hepatocellular carcinoma (HCC) received a dose of 3 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: HCC Ascending Dose 1200mg
Subjects with HCC received a flat ascending dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: HCC-2L
Subjects with HCC-2L received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Melanoma PD-L1 Fail
Participants with Melanoma prior programmed death ligand-1 treatment failure (Melanoma PD-L1 Fail) received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC PD-L1 Fail
Participants with Non-small Cell Lung Cancer (NSCLC) PD-L1 Fail (must have received and failed platinum-based chemotherapy and must have received anti-PD-1 or anti-PD-L1 as monotherapy and failed with disease progression) received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Pancreatic Adenocarcinoma
Participants with Pancreatic Adenocarcinoma received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Esophageal Adenocarcinoma
Participants with Esophageal Adenocarcinoma received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Colorectal Carcinoma
Participants with Colorectal Carcinoma received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Triple Negative Breast Cancer
Participants with Triple Negative Breast Cancer received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Glioblastoma
Participants with Glioblastoma received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Squamous Cell Carcinoma of Head and Neck
Participants with Squamous Cell Carcinoma of Head and Neck received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Cervical Cancer
Participants with Cervical Cancer received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC-2L 1200 mg
Participants with NSCLC second line (NSCLC-2L) received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC-2L 500 mg
Participants with NSCLC-2L received a flat dose of 500 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC Biomarker
Participants with NSCLC Biomarker (who were naïve to the anti-PD-1/anti-PD-L1 class and had relapsed, refractory, or PD following an anti-PD-1 or anti-PD-L1 agent) received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Death
|
2
|
3
|
4
|
2
|
3
|
8
|
3
|
2
|
6
|
24
|
53
|
25
|
73
|
29
|
26
|
23
|
26
|
25
|
22
|
7
|
26
|
30
|
20
|
|
Overall Study
Other
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
1
|
0
|
1
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
2
|
2
|
0
|
1
|
1
|
0
|
3
|
1
|
0
|
1
|
0
|
2
|
|
Overall Study
Withdrew Consent
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
2
|
7
|
1
|
5
|
4
|
2
|
5
|
4
|
2
|
3
|
2
|
9
|
3
|
1
|
Baseline Characteristics
MSB0011359C (M7824) in Metastatic or Locally Advanced Solid Tumors
Baseline characteristics by cohort
| Measure |
Dose-escalation: M7824 0.3 - 10 mg/kg
n=3 Participants
Participants received a dose of 0.3 milligram per kilogram (mg/kg) M7824 intravenous (IV) infusion as a first dose and then switched to a 10 mg/kg as a second dose over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or investigational medicinal product (IMP) occurs.
|
Dose-escalation: M7824 1 mg/kg
n=3 Participants
Participants received a dose of 1 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 1 - 1200 mg
n=4 Participants
Participants received IV infusion of M7824 1 mg/kg over 1 hour as first dose switched to a 1200 milligram per infusion (mg/infusion) over 1 hour as second dose once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 3 mg/kg
n=3 Participants
Participants received a dose of 3 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 10 mg/kg
n=6 Participants
Participants received a dose of 10 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 20 mg/kg
n=10 Participants
Participants received a dose of 20 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 30 mg/kg
n=7 Participants
Participants received a dose of 30 mg/kg M7824 IV infusion over 2 hours once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 2400 mg/Infusion
n=3 Participants
Participants received a flat dose of 2400 mg/infusion M7824 IV infusion over 2 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: HCC-3 mg/kg
n=6 Participants
Participants with Hepatocellular carcinoma (HCC) received a dose of 3 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: HCC Ascending Dose 1200mg
n=38 Participants
Subjects with HCC received a flat ascending dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: HCC-2L
n=68 Participants
Subjects with HCC-2L received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Melanoma PD-L1 Fail
n=32 Participants
Participants with Melanoma prior programmed death ligand-1 treatment failure (Melanoma PD-L1 Fail) received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC PD-L1 Fail
n=83 Participants
Participants with Non-small Cell Lung Cancer (NSCLC) PD-L1 Fail (must have received and failed platinum-based chemotherapy and must have received anti-PD-1 or anti-PD-L1 as monotherapy and failed with disease progression) received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Pancreatic Adenocarcinoma
n=36 Participants
Participants with Pancreatic Adenocarcinoma received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Esophageal Adenocarcinoma
n=30 Participants
Participants with Esophageal Adenocarcinoma received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Colorectal Carcinoma
n=32 Participants
Participants with Colorectal Carcinoma received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Triple Negative Breast Cancer
n=33 Participants
Participants with Triple Negative Breast Cancer received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Glioblastoma
n=35 Participants
Participants with Glioblastoma received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Squamous Cell Carcinoma of Head and Neck
n=32 Participants
Participants with Squamous Cell Carcinoma of Head and Neck received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Cervical Cancer
n=15 Participants
Participants with Cervical Cancer received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC-2L 1200 mg
n=40 Participants
Participants with NSCLC second line (NSCLC-2L) received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC-2L 500 mg
n=40 Participants
Participants with NSCLC-2L received a flat dose of 500 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC Biomarker
n=41 Participants
Participants with NSCLC Biomarker (who were naïve to the anti-PD-1/anti-PD-L1 class and had relapsed, refractory, or PD following an anti-PD-1 or anti-PD-L1 agent) received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Total
n=600 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=125 Participants
|
0 Participants
n=117 Participants
|
0 Participants
n=1256 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=600 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
23 Participants
n=42 Participants
|
28 Participants
n=42 Participants
|
16 Participants
n=42 Participants
|
46 Participants
n=36 Participants
|
23 Participants
n=36 Participants
|
19 Participants
n=24 Participants
|
21 Participants
n=135 Participants
|
31 Participants
n=136 Participants
|
30 Participants
n=44 Participants
|
22 Participants
n=667 Participants
|
13 Participants
n=125 Participants
|
25 Participants
n=117 Participants
|
19 Participants
n=1256 Participants
|
17 Participants
n=41 Participants
|
364 Participants
n=600 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
15 Participants
n=42 Participants
|
40 Participants
n=42 Participants
|
16 Participants
n=42 Participants
|
37 Participants
n=36 Participants
|
13 Participants
n=36 Participants
|
11 Participants
n=24 Participants
|
11 Participants
n=135 Participants
|
2 Participants
n=136 Participants
|
5 Participants
n=44 Participants
|
10 Participants
n=667 Participants
|
2 Participants
n=125 Participants
|
15 Participants
n=117 Participants
|
21 Participants
n=1256 Participants
|
24 Participants
n=41 Participants
|
236 Participants
n=600 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
11 Participants
n=42 Participants
|
13 Participants
n=42 Participants
|
27 Participants
n=36 Participants
|
14 Participants
n=36 Participants
|
2 Participants
n=24 Participants
|
16 Participants
n=135 Participants
|
33 Participants
n=136 Participants
|
11 Participants
n=44 Participants
|
5 Participants
n=667 Participants
|
15 Participants
n=125 Participants
|
7 Participants
n=117 Participants
|
16 Participants
n=1256 Participants
|
18 Participants
n=41 Participants
|
217 Participants
n=600 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
32 Participants
n=42 Participants
|
57 Participants
n=42 Participants
|
19 Participants
n=42 Participants
|
56 Participants
n=36 Participants
|
22 Participants
n=36 Participants
|
28 Participants
n=24 Participants
|
16 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
24 Participants
n=44 Participants
|
27 Participants
n=667 Participants
|
0 Participants
n=125 Participants
|
33 Participants
n=117 Participants
|
24 Participants
n=1256 Participants
|
23 Participants
n=41 Participants
|
383 Participants
n=600 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
2 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
1 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=125 Participants
|
1 Participants
n=117 Participants
|
1 Participants
n=1256 Participants
|
1 Participants
n=41 Participants
|
23 Participants
n=600 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
26 Participants
n=42 Participants
|
49 Participants
n=42 Participants
|
26 Participants
n=42 Participants
|
55 Participants
n=36 Participants
|
33 Participants
n=36 Participants
|
27 Participants
n=24 Participants
|
31 Participants
n=135 Participants
|
23 Participants
n=136 Participants
|
28 Participants
n=44 Participants
|
17 Participants
n=667 Participants
|
14 Participants
n=125 Participants
|
39 Participants
n=117 Participants
|
39 Participants
n=1256 Participants
|
38 Participants
n=41 Participants
|
481 Participants
n=600 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
17 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
28 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
3 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
10 Participants
n=136 Participants
|
6 Participants
n=44 Participants
|
15 Participants
n=667 Participants
|
1 Participants
n=125 Participants
|
0 Participants
n=117 Participants
|
0 Participants
n=1256 Participants
|
2 Participants
n=41 Participants
|
96 Participants
n=600 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=125 Participants
|
0 Participants
n=117 Participants
|
0 Participants
n=1256 Participants
|
0 Participants
n=41 Participants
|
2 Participants
n=600 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
11 Participants
n=42 Participants
|
26 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
11 Participants
n=36 Participants
|
2 Participants
n=36 Participants
|
2 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
1 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
5 Participants
n=667 Participants
|
2 Participants
n=125 Participants
|
25 Participants
n=117 Participants
|
15 Participants
n=1256 Participants
|
3 Participants
n=41 Participants
|
104 Participants
n=600 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=125 Participants
|
0 Participants
n=117 Participants
|
0 Participants
n=1256 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=600 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=36 Participants
|
7 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=135 Participants
|
4 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
1 Participants
n=667 Participants
|
1 Participants
n=125 Participants
|
1 Participants
n=117 Participants
|
0 Participants
n=1256 Participants
|
0 Participants
n=41 Participants
|
26 Participants
n=600 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
13 Participants
n=42 Participants
|
22 Participants
n=42 Participants
|
26 Participants
n=42 Participants
|
40 Participants
n=36 Participants
|
25 Participants
n=36 Participants
|
25 Participants
n=24 Participants
|
29 Participants
n=135 Participants
|
18 Participants
n=136 Participants
|
27 Participants
n=44 Participants
|
12 Participants
n=667 Participants
|
10 Participants
n=125 Participants
|
14 Participants
n=117 Participants
|
25 Participants
n=1256 Participants
|
30 Participants
n=41 Participants
|
350 Participants
n=600 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=36 Participants
|
2 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
3 Participants
n=136 Participants
|
2 Participants
n=44 Participants
|
3 Participants
n=667 Participants
|
1 Participants
n=125 Participants
|
0 Participants
n=117 Participants
|
0 Participants
n=1256 Participants
|
0 Participants
n=41 Participants
|
25 Participants
n=600 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
16 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
28 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
3 Participants
n=24 Participants
|
1 Participants
n=135 Participants
|
7 Participants
n=136 Participants
|
6 Participants
n=44 Participants
|
11 Participants
n=667 Participants
|
1 Participants
n=125 Participants
|
0 Participants
n=117 Participants
|
0 Participants
n=1256 Participants
|
8 Participants
n=41 Participants
|
93 Participants
n=600 Participants
|
PRIMARY outcome
Timeframe: From start of study drug administration up to 139 weeksPopulation: Safety Analysis Set (SAS) included all randomized participants who received at least 1 dose of study treatment.
Adverse event (AE): any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. Serious AE: an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAE: AE with onset after start of treatment or with onset date before the treatment start date but worsening after the treatment start date. TEAEs included both serious and non-serious TEAEs.
Outcome measures
| Measure |
Dose-escalation: M7824 0.3 - 10 mg/kg
n=3 Participants
Participants received a dose of 0.3 mg/kg M7824 IV infusion as a first dose and then switched to a 10 mg/kg as a second dose over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 1 mg/kg
n=3 Participants
Participants received a dose of 1 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs
|
Dose-escalation: M7824 1 - 1200 mg
n=4 Participants
Participants received IV infusion of M7824 1 mg/kg over 1 hour as first dose switched to a 1200 milligram per infusion (mg/infusion) over 1 hour as second dose once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 3 mg/kg
n=3 Participants
Participants received a dose of 3 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs
|
Dose-escalation: M7824 10 mg/kg
n=6 Participants
Participants received a dose of 10 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 20 mg/kg
n=10 Participants
Participants received a dose of 20 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 30 mg/kg
n=7 Participants
Participants received a dose of 30 mg/kg M7824 IV infusion over 2 hours once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 2400 mg/Infusion
n=3 Participants
Participants received a flat dose of 2400 mg/infusion M7824 IV infusion over 2 hours once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs
|
Dose-escalation: HCC-3 mg/kg
n=6 Participants
Participants with Hepatocellular carcinoma (HCC) received a dose of 3 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs
|
Dose-expansion: Squamous Cell Carcinoma of Head and Neck
Participants with Squamous Cell Carcinoma of Head and Neck received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Cervical Cancer
Participants with Cervical Cancer received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC-2L 1200 mg
Participants with NSCLC-2L received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs
|
Dose-expansion: NSCLC-2L 500 mg
Participants with NSCLC-2L received a flat dose of 500 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC Biomarker
Participants with NSCLC Biomarker (who were naïve to the anti-PD-1/anti-PD-L1 class and had relapsed, refractory, or PD following an anti-PD-1 or anti-PD-L1 agent) received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Esophageal Adenocarcinoma
Participants with Esophageal Adenocarcinoma received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Colorectal Carcinoma
Participants with Colorectal Carcinoma received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Triple Negative Breast Cancer
Participants with Triple Negative Breast Cancer received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Glioblastoma
Participants with Glioblastoma received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Squamous Cell Carcinoma of Head and Neck
Participants with Squamous Cell Carcinoma of Head and Neck received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Cervical Cancer
Participants with Cervical Cancer received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC-2L 1200 mg
Participants with NSCLC-2L received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC-2L 500 mg
Participants with NSCLC-2L received a flat dose of 500 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC Biomarker
Participants with NSCLC Biomarker (who were naïve to the anti-PD-1/anti-PD-L1 class and had relapsed, refractory, or PD following an anti-PD-1 or anti-PD-L1 agent) received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose-escalation: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
Participants with TEAEs
|
3 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
6 Participants
|
10 Participants
|
7 Participants
|
3 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose-escalation: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
Participants with Serious TEAEs
|
2 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
8 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From start of study drug administration up to 139 weeksPopulation: SAS included all randomized participants who received at least 1 dose of study treatment.
Treatment-related TEAEs are any untoward medical occurrence in a participant who received study drug with causal relationship with the investigational product as assessed by the investigator. Related TEAEs were events with relationship missing, unknown or yes. Number of participants With treatment-related TEAEs, treatment-related serious TEAEs and treatment-related TEAE leading to death were reported.
Outcome measures
| Measure |
Dose-escalation: M7824 0.3 - 10 mg/kg
n=3 Participants
Participants received a dose of 0.3 mg/kg M7824 IV infusion as a first dose and then switched to a 10 mg/kg as a second dose over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 1 mg/kg
n=3 Participants
Participants received a dose of 1 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs
|
Dose-escalation: M7824 1 - 1200 mg
n=4 Participants
Participants received IV infusion of M7824 1 mg/kg over 1 hour as first dose switched to a 1200 milligram per infusion (mg/infusion) over 1 hour as second dose once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 3 mg/kg
n=3 Participants
Participants received a dose of 3 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs
|
Dose-escalation: M7824 10 mg/kg
n=6 Participants
Participants received a dose of 10 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 20 mg/kg
n=10 Participants
Participants received a dose of 20 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 30 mg/kg
n=7 Participants
Participants received a dose of 30 mg/kg M7824 IV infusion over 2 hours once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 2400 mg/Infusion
n=3 Participants
Participants received a flat dose of 2400 mg/infusion M7824 IV infusion over 2 hours once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs
|
Dose-escalation: HCC-3 mg/kg
n=6 Participants
Participants with Hepatocellular carcinoma (HCC) received a dose of 3 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs
|
Dose-expansion: Squamous Cell Carcinoma of Head and Neck
Participants with Squamous Cell Carcinoma of Head and Neck received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Cervical Cancer
Participants with Cervical Cancer received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC-2L 1200 mg
Participants with NSCLC-2L received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs
|
Dose-expansion: NSCLC-2L 500 mg
Participants with NSCLC-2L received a flat dose of 500 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC Biomarker
Participants with NSCLC Biomarker (who were naïve to the anti-PD-1/anti-PD-L1 class and had relapsed, refractory, or PD following an anti-PD-1 or anti-PD-L1 agent) received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Esophageal Adenocarcinoma
Participants with Esophageal Adenocarcinoma received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Colorectal Carcinoma
Participants with Colorectal Carcinoma received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Triple Negative Breast Cancer
Participants with Triple Negative Breast Cancer received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Glioblastoma
Participants with Glioblastoma received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Squamous Cell Carcinoma of Head and Neck
Participants with Squamous Cell Carcinoma of Head and Neck received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Cervical Cancer
Participants with Cervical Cancer received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC-2L 1200 mg
Participants with NSCLC-2L received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC-2L 500 mg
Participants with NSCLC-2L received a flat dose of 500 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC Biomarker
Participants with NSCLC Biomarker (who were naïve to the anti-PD-1/anti-PD-L1 class and had relapsed, refractory, or PD following an anti-PD-1 or anti-PD-L1 agent) received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose-escalation: Number of Participants With Treatment-Related TEAEs, Treatment-Related Serious TEAEs and Treatment-related TEAEs Leading to Death
Treatment-related TEAE leading to death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose-escalation: Number of Participants With Treatment-Related TEAEs, Treatment-Related Serious TEAEs and Treatment-related TEAEs Leading to Death
Treatment-related TEAEs
|
2 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
5 Participants
|
6 Participants
|
7 Participants
|
2 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose-escalation: Number of Participants With Treatment-Related TEAEs, Treatment-Related Serious TEAEs and Treatment-related TEAEs Leading to Death
Treatment-related serious TEAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From start of study drug administration up to 139 weeksPopulation: SAS included all randomized participants who received at least 1 dose of study treatment.
AEs were graded according to severity using NCI-CTCAE Version 4.03. Severity of TEAEs were graded as Grade 1: mild (not causing any significant problem, dose adjustment not required), Grade 2: moderate (caused problem that does not interfere significantly with usual activities or the clinical status, dose adjustment needed due to adverse event), Grade 3: Severe (caused problem that interferes significantly with usual activities or the clinical status, study drug stopped due to adverse event), Grade 4: Life-threatening, Grade 5: Death. Number of Participants with TEAEs and Related TEAEs Based on Severity having Grade greater than or equal to (\>=) 3 and Grade \>=4 were reported.
Outcome measures
| Measure |
Dose-escalation: M7824 0.3 - 10 mg/kg
n=3 Participants
Participants received a dose of 0.3 mg/kg M7824 IV infusion as a first dose and then switched to a 10 mg/kg as a second dose over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 1 mg/kg
n=3 Participants
Participants received a dose of 1 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs
|
Dose-escalation: M7824 1 - 1200 mg
n=4 Participants
Participants received IV infusion of M7824 1 mg/kg over 1 hour as first dose switched to a 1200 milligram per infusion (mg/infusion) over 1 hour as second dose once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 3 mg/kg
n=3 Participants
Participants received a dose of 3 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs
|
Dose-escalation: M7824 10 mg/kg
n=6 Participants
Participants received a dose of 10 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 20 mg/kg
n=10 Participants
Participants received a dose of 20 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 30 mg/kg
n=7 Participants
Participants received a dose of 30 mg/kg M7824 IV infusion over 2 hours once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 2400 mg/Infusion
n=3 Participants
Participants received a flat dose of 2400 mg/infusion M7824 IV infusion over 2 hours once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs
|
Dose-escalation: HCC-3 mg/kg
n=6 Participants
Participants with Hepatocellular carcinoma (HCC) received a dose of 3 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs
|
Dose-expansion: Squamous Cell Carcinoma of Head and Neck
Participants with Squamous Cell Carcinoma of Head and Neck received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Cervical Cancer
Participants with Cervical Cancer received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC-2L 1200 mg
Participants with NSCLC-2L received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs
|
Dose-expansion: NSCLC-2L 500 mg
Participants with NSCLC-2L received a flat dose of 500 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC Biomarker
Participants with NSCLC Biomarker (who were naïve to the anti-PD-1/anti-PD-L1 class and had relapsed, refractory, or PD following an anti-PD-1 or anti-PD-L1 agent) received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Esophageal Adenocarcinoma
Participants with Esophageal Adenocarcinoma received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Colorectal Carcinoma
Participants with Colorectal Carcinoma received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Triple Negative Breast Cancer
Participants with Triple Negative Breast Cancer received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Glioblastoma
Participants with Glioblastoma received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Squamous Cell Carcinoma of Head and Neck
Participants with Squamous Cell Carcinoma of Head and Neck received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Cervical Cancer
Participants with Cervical Cancer received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC-2L 1200 mg
Participants with NSCLC-2L received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC-2L 500 mg
Participants with NSCLC-2L received a flat dose of 500 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC Biomarker
Participants with NSCLC Biomarker (who were naïve to the anti-PD-1/anti-PD-L1 class and had relapsed, refractory, or PD following an anti-PD-1 or anti-PD-L1 agent) received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With TEAEs and Related TEAEs Based on Severity According to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE) Version 4.03
Grade >= 3 TEAE
|
3 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
7 Participants
|
5 Participants
|
2 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With TEAEs and Related TEAEs Based on Severity According to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE) Version 4.03
Grade >= 4 TEAE
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With TEAEs and Related TEAEs Based on Severity According to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE) Version 4.03
Treatment-related Grade >= 3 TEAE
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With TEAEs and Related TEAEs Based on Severity According to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE) Version 4.03
Treatment-related Grade >= 4 TEAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From start of study drug administration up to 21 daysPopulation: DLT Analysis Set included all participants who received all study treatment administrations in the DLT-evaluation period or stopped treatment because of DLTs in the DLT-evaluation period. Data was planned not to be collected and analyzed for the arms: Dose-escalation: M7824 0.3 - 10 mg/kg, Dose-escalation: M7824 1 - 1200 mg and Dose-escalation: HCC-3 mg/kg.
A DLT was defined as any grade \>= 3 Adverse Event (AE) suspected to be related to IMP by the Investigator and / or Sponsor occurring in the DLT evaluation period confirmed by the Safety Monitoring Committee (SMC) to be relevant for the IMP treatment. According to the NCI-CTCAE, v4.03, occurring in the DLT evaluation period and assessed to be related to study treatment by the Investigator and / or Sponsor confirmed by the safety monitoring committee to be relevant for the study treatment.
Outcome measures
| Measure |
Dose-escalation: M7824 0.3 - 10 mg/kg
n=3 Participants
Participants received a dose of 0.3 mg/kg M7824 IV infusion as a first dose and then switched to a 10 mg/kg as a second dose over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 1 mg/kg
n=3 Participants
Participants received a dose of 1 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs
|
Dose-escalation: M7824 1 - 1200 mg
n=3 Participants
Participants received IV infusion of M7824 1 mg/kg over 1 hour as first dose switched to a 1200 milligram per infusion (mg/infusion) over 1 hour as second dose once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 3 mg/kg
n=7 Participants
Participants received a dose of 3 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs
|
Dose-escalation: M7824 10 mg/kg
n=7 Participants
Participants received a dose of 10 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 20 mg/kg
n=2 Participants
Participants received a dose of 20 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 30 mg/kg
Participants received a dose of 30 mg/kg M7824 IV infusion over 2 hours once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 2400 mg/Infusion
Participants received a flat dose of 2400 mg/infusion M7824 IV infusion over 2 hours once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs
|
Dose-escalation: HCC-3 mg/kg
Participants with Hepatocellular carcinoma (HCC) received a dose of 3 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs
|
Dose-expansion: Squamous Cell Carcinoma of Head and Neck
Participants with Squamous Cell Carcinoma of Head and Neck received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Cervical Cancer
Participants with Cervical Cancer received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC-2L 1200 mg
Participants with NSCLC-2L received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs
|
Dose-expansion: NSCLC-2L 500 mg
Participants with NSCLC-2L received a flat dose of 500 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC Biomarker
Participants with NSCLC Biomarker (who were naïve to the anti-PD-1/anti-PD-L1 class and had relapsed, refractory, or PD following an anti-PD-1 or anti-PD-L1 agent) received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Esophageal Adenocarcinoma
Participants with Esophageal Adenocarcinoma received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Colorectal Carcinoma
Participants with Colorectal Carcinoma received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Triple Negative Breast Cancer
Participants with Triple Negative Breast Cancer received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Glioblastoma
Participants with Glioblastoma received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Squamous Cell Carcinoma of Head and Neck
Participants with Squamous Cell Carcinoma of Head and Neck received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Cervical Cancer
Participants with Cervical Cancer received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC-2L 1200 mg
Participants with NSCLC-2L received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC-2L 500 mg
Participants with NSCLC-2L received a flat dose of 500 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC Biomarker
Participants with NSCLC Biomarker (who were naïve to the anti-PD-1/anti-PD-L1 class and had relapsed, refractory, or PD following an anti-PD-1 or anti-PD-L1 agent) received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose-escalation: Number of Participants With Dose-Limiting Toxicities According to the National Cancer Institute Common Terminology Criteria For Adverse Events(NCI-CTCAE), v4.03
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From date of randomization up to Week 66Population: FAS included all participants who received at least 1 dose of study treatment.
BOR according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 and as adjudicated by the Independent Endpoint Review Committee (IRC). BOR is defined as sum of complete response and partial response (CR+PR). For target lesions (TLs), CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the sum of largest diameter (SLD) of the TLs, taking as a reference the baseline SLD.
Outcome measures
| Measure |
Dose-escalation: M7824 0.3 - 10 mg/kg
n=38 Participants
Participants received a dose of 0.3 mg/kg M7824 IV infusion as a first dose and then switched to a 10 mg/kg as a second dose over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 1 mg/kg
n=68 Participants
Participants received a dose of 1 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs
|
Dose-escalation: M7824 1 - 1200 mg
n=32 Participants
Participants received IV infusion of M7824 1 mg/kg over 1 hour as first dose switched to a 1200 milligram per infusion (mg/infusion) over 1 hour as second dose once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 3 mg/kg
n=83 Participants
Participants received a dose of 3 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs
|
Dose-escalation: M7824 10 mg/kg
n=36 Participants
Participants received a dose of 10 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 20 mg/kg
n=30 Participants
Participants received a dose of 20 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 30 mg/kg
n=32 Participants
Participants received a dose of 30 mg/kg M7824 IV infusion over 2 hours once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 2400 mg/Infusion
n=33 Participants
Participants received a flat dose of 2400 mg/infusion M7824 IV infusion over 2 hours once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs
|
Dose-escalation: HCC-3 mg/kg
n=35 Participants
Participants with Hepatocellular carcinoma (HCC) received a dose of 3 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs
|
Dose-expansion: Squamous Cell Carcinoma of Head and Neck
n=32 Participants
Participants with Squamous Cell Carcinoma of Head and Neck received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Cervical Cancer
n=15 Participants
Participants with Cervical Cancer received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC-2L 1200 mg
n=40 Participants
Participants with NSCLC-2L received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs
|
Dose-expansion: NSCLC-2L 500 mg
n=40 Participants
Participants with NSCLC-2L received a flat dose of 500 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC Biomarker
n=41 Participants
Participants with NSCLC Biomarker (who were naïve to the anti-PD-1/anti-PD-L1 class and had relapsed, refractory, or PD following an anti-PD-1 or anti-PD-L1 agent) received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Esophageal Adenocarcinoma
Participants with Esophageal Adenocarcinoma received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Colorectal Carcinoma
Participants with Colorectal Carcinoma received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Triple Negative Breast Cancer
Participants with Triple Negative Breast Cancer received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Glioblastoma
Participants with Glioblastoma received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Squamous Cell Carcinoma of Head and Neck
Participants with Squamous Cell Carcinoma of Head and Neck received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Cervical Cancer
Participants with Cervical Cancer received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC-2L 1200 mg
Participants with NSCLC-2L received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC-2L 500 mg
Participants with NSCLC-2L received a flat dose of 500 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC Biomarker
Participants with NSCLC Biomarker (who were naïve to the anti-PD-1/anti-PD-L1 class and had relapsed, refractory, or PD following an anti-PD-1 or anti-PD-L1 agent) received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose-expansion: Number of Participants With Best Overall Response (BOR) as Assessed by Independent Endpoint Review Committee (IRC)
Complete response (CR)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose-expansion: Number of Participants With Best Overall Response (BOR) as Assessed by Independent Endpoint Review Committee (IRC)
Partial response (PR)
|
4 Participants
|
6 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
6 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
7 Participants
|
9 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From date of randomization up to Week 66Population: FAS included all participants who received at least 1 dose of study treatment. Data was planned, collected and analyzed only for participants with glioblastoma.
DCR is defined as the percentage of participants with a confirmed CR+PR+SD+ Non-CR/non-PD at any time as per RANO criteria. A responder is a participant with a Complete Response (CR) or Partial Response (PR), and a non-responder is a participant with Stable Disease (SD) or Progressive Disease (PD) assessed by the RANO criteria. CR is no T1 gadolinium enhancing disease, no new lesions, or corticosteroids, and stable or decreasing T2-weighted-Fluid-Attenuated Inversion Recovery (T2/FLAIR). PR is ≥50% decrease in T1 gadolinium enhancing disease, no new lesions, stable or decreasing T2/FLAIR or corticosteroids, and stable or increasing clinical status. SD is \<50% decrease in T1 gadolinium enhancing disease but \< 25% increase, no new lesions, stable or decreasing T2/FLAIR or corticosteroids, and stable or increase in clinical status. PD is ≥25% increase in T1 gadolinium enhancing disease.
Outcome measures
| Measure |
Dose-escalation: M7824 0.3 - 10 mg/kg
n=35 Participants
Participants received a dose of 0.3 mg/kg M7824 IV infusion as a first dose and then switched to a 10 mg/kg as a second dose over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 1 mg/kg
Participants received a dose of 1 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs
|
Dose-escalation: M7824 1 - 1200 mg
Participants received IV infusion of M7824 1 mg/kg over 1 hour as first dose switched to a 1200 milligram per infusion (mg/infusion) over 1 hour as second dose once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 3 mg/kg
Participants received a dose of 3 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs
|
Dose-escalation: M7824 10 mg/kg
Participants received a dose of 10 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 20 mg/kg
Participants received a dose of 20 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 30 mg/kg
Participants received a dose of 30 mg/kg M7824 IV infusion over 2 hours once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 2400 mg/Infusion
Participants received a flat dose of 2400 mg/infusion M7824 IV infusion over 2 hours once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs
|
Dose-escalation: HCC-3 mg/kg
Participants with Hepatocellular carcinoma (HCC) received a dose of 3 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs
|
Dose-expansion: Squamous Cell Carcinoma of Head and Neck
Participants with Squamous Cell Carcinoma of Head and Neck received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Cervical Cancer
Participants with Cervical Cancer received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC-2L 1200 mg
Participants with NSCLC-2L received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs
|
Dose-expansion: NSCLC-2L 500 mg
Participants with NSCLC-2L received a flat dose of 500 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC Biomarker
Participants with NSCLC Biomarker (who were naïve to the anti-PD-1/anti-PD-L1 class and had relapsed, refractory, or PD following an anti-PD-1 or anti-PD-L1 agent) received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Esophageal Adenocarcinoma
Participants with Esophageal Adenocarcinoma received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Colorectal Carcinoma
Participants with Colorectal Carcinoma received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Triple Negative Breast Cancer
Participants with Triple Negative Breast Cancer received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Glioblastoma
Participants with Glioblastoma received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Squamous Cell Carcinoma of Head and Neck
Participants with Squamous Cell Carcinoma of Head and Neck received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Cervical Cancer
Participants with Cervical Cancer received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC-2L 1200 mg
Participants with NSCLC-2L received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC-2L 500 mg
Participants with NSCLC-2L received a flat dose of 500 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC Biomarker
Participants with NSCLC Biomarker (who were naïve to the anti-PD-1/anti-PD-L1 class and had relapsed, refractory, or PD following an anti-PD-1 or anti-PD-L1 agent) received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose-expansion: Disease Control Rate According to Response Assessment in Neuro-Oncology (RANO) as Adjudicated by the IRC for Participants With Glioblastoma
|
22.9 Percentage of participants
Interval 10.4 to 40.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0 hours (pre-dose), 1, 4, 10, 25, 72, 168, 240, 336 hours post-dosePopulation: PK Analysis Set included all who received at least 1 dose of study treatment, and who provided at least 1 post-baseline sample with a measurable concentration. Here, 'Overall number of participants analyzed' signifies participants who were evaluable for this outcome measure. As per planned analysis combined PK data was collected for the dose cohorts (\[1 mg/kg +1-1200 mg/kg and 3 mg/kg +HCC-3 mg/kg\]) in dose escalation and 1200mg of all solid tumors in dose expansion.
Cmax was obtained directly from the concentration versus time curve.
Outcome measures
| Measure |
Dose-escalation: M7824 0.3 - 10 mg/kg
n=3 Participants
Participants received a dose of 0.3 mg/kg M7824 IV infusion as a first dose and then switched to a 10 mg/kg as a second dose over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 1 mg/kg
n=7 Participants
Participants received a dose of 1 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs
|
Dose-escalation: M7824 1 - 1200 mg
n=9 Participants
Participants received IV infusion of M7824 1 mg/kg over 1 hour as first dose switched to a 1200 milligram per infusion (mg/infusion) over 1 hour as second dose once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 3 mg/kg
n=6 Participants
Participants received a dose of 3 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs
|
Dose-escalation: M7824 10 mg/kg
n=10 Participants
Participants received a dose of 10 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 20 mg/kg
n=7 Participants
Participants received a dose of 20 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 30 mg/kg
n=3 Participants
Participants received a dose of 30 mg/kg M7824 IV infusion over 2 hours once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 2400 mg/Infusion
n=507 Participants
Participants received a flat dose of 2400 mg/infusion M7824 IV infusion over 2 hours once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs
|
Dose-escalation: HCC-3 mg/kg
n=40 Participants
Participants with Hepatocellular carcinoma (HCC) received a dose of 3 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs
|
Dose-expansion: Squamous Cell Carcinoma of Head and Neck
Participants with Squamous Cell Carcinoma of Head and Neck received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Cervical Cancer
Participants with Cervical Cancer received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC-2L 1200 mg
Participants with NSCLC-2L received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs
|
Dose-expansion: NSCLC-2L 500 mg
Participants with NSCLC-2L received a flat dose of 500 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC Biomarker
Participants with NSCLC Biomarker (who were naïve to the anti-PD-1/anti-PD-L1 class and had relapsed, refractory, or PD following an anti-PD-1 or anti-PD-L1 agent) received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Esophageal Adenocarcinoma
Participants with Esophageal Adenocarcinoma received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Colorectal Carcinoma
Participants with Colorectal Carcinoma received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Triple Negative Breast Cancer
Participants with Triple Negative Breast Cancer received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Glioblastoma
Participants with Glioblastoma received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Squamous Cell Carcinoma of Head and Neck
Participants with Squamous Cell Carcinoma of Head and Neck received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Cervical Cancer
Participants with Cervical Cancer received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC-2L 1200 mg
Participants with NSCLC-2L received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC-2L 500 mg
Participants with NSCLC-2L received a flat dose of 500 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC Biomarker
Participants with NSCLC Biomarker (who were naïve to the anti-PD-1/anti-PD-L1 class and had relapsed, refractory, or PD following an anti-PD-1 or anti-PD-L1 agent) received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Concentration (Cmax) of M7824 in Plasma
|
7.08 micrograms per milliliter (mcg/ml)
Geometric Coefficient of Variation 9.1
|
22.5 micrograms per milliliter (mcg/ml)
Geometric Coefficient of Variation 44.2
|
92.8 micrograms per milliliter (mcg/ml)
Geometric Coefficient of Variation 74.8
|
233 micrograms per milliliter (mcg/ml)
Geometric Coefficient of Variation 9.1
|
503 micrograms per milliliter (mcg/ml)
Geometric Coefficient of Variation 15.7
|
766 micrograms per milliliter (mcg/ml)
Geometric Coefficient of Variation 8.0
|
943 micrograms per milliliter (mcg/ml)
Geometric Coefficient of Variation 19.7
|
411 micrograms per milliliter (mcg/ml)
Geometric Coefficient of Variation 28.5
|
185 micrograms per milliliter (mcg/ml)
Geometric Coefficient of Variation 39.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0 hours (pre-dose), 1, 4, 10, 25, 72, 168, 240, 336 hours post-dose post-dosePopulation: Pharmacokinetic Analysis Set included all participants who received at least 1 dose of IMP, and who provided at least 1 post-baseline sample with a measurable concentration of IMP. Here, 'Overall number of participants analyzed' signifies participants who were evaluable for this outcome measure. As per planned analysis combined PK data was collected for the dose cohorts (\[1 mg/kg +1-1200 mg/kg and 3 mg/kg +HCC-3 mg/kg\]) in dose escalation and 1200mg of all solid tumors in dose expansion.
Area under the concentration-time curve from time zero up to time Tau, where Tau is the dosing interval (336 hours).
Outcome measures
| Measure |
Dose-escalation: M7824 0.3 - 10 mg/kg
n=3 Participants
Participants received a dose of 0.3 mg/kg M7824 IV infusion as a first dose and then switched to a 10 mg/kg as a second dose over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 1 mg/kg
n=6 Participants
Participants received a dose of 1 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs
|
Dose-escalation: M7824 1 - 1200 mg
n=6 Participants
Participants received IV infusion of M7824 1 mg/kg over 1 hour as first dose switched to a 1200 milligram per infusion (mg/infusion) over 1 hour as second dose once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 3 mg/kg
n=5 Participants
Participants received a dose of 3 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs
|
Dose-escalation: M7824 10 mg/kg
n=9 Participants
Participants received a dose of 10 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 20 mg/kg
n=7 Participants
Participants received a dose of 20 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 30 mg/kg
n=3 Participants
Participants received a dose of 30 mg/kg M7824 IV infusion over 2 hours once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 2400 mg/Infusion
n=408 Participants
Participants received a flat dose of 2400 mg/infusion M7824 IV infusion over 2 hours once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs
|
Dose-escalation: HCC-3 mg/kg
n=31 Participants
Participants with Hepatocellular carcinoma (HCC) received a dose of 3 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs
|
Dose-expansion: Squamous Cell Carcinoma of Head and Neck
Participants with Squamous Cell Carcinoma of Head and Neck received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Cervical Cancer
Participants with Cervical Cancer received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC-2L 1200 mg
Participants with NSCLC-2L received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs
|
Dose-expansion: NSCLC-2L 500 mg
Participants with NSCLC-2L received a flat dose of 500 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC Biomarker
Participants with NSCLC Biomarker (who were naïve to the anti-PD-1/anti-PD-L1 class and had relapsed, refractory, or PD following an anti-PD-1 or anti-PD-L1 agent) received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Esophageal Adenocarcinoma
Participants with Esophageal Adenocarcinoma received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Colorectal Carcinoma
Participants with Colorectal Carcinoma received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Triple Negative Breast Cancer
Participants with Triple Negative Breast Cancer received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Glioblastoma
Participants with Glioblastoma received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Squamous Cell Carcinoma of Head and Neck
Participants with Squamous Cell Carcinoma of Head and Neck received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Cervical Cancer
Participants with Cervical Cancer received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC-2L 1200 mg
Participants with NSCLC-2L received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC-2L 500 mg
Participants with NSCLC-2L received a flat dose of 500 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC Biomarker
Participants with NSCLC Biomarker (who were naïve to the anti-PD-1/anti-PD-L1 class and had relapsed, refractory, or PD following an anti-PD-1 or anti-PD-L1 agent) received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-Time Curve From Time Zero up to Time Tau (AUCtau) of M7824
|
747 hour*microgram per milliliter (h*mcg/ml)
Geometric Coefficient of Variation 25.0
|
3170 hour*microgram per milliliter (h*mcg/ml)
Geometric Coefficient of Variation 38.6
|
11000 hour*microgram per milliliter (h*mcg/ml)
Geometric Coefficient of Variation 33.6
|
32600 hour*microgram per milliliter (h*mcg/ml)
Geometric Coefficient of Variation 10.1
|
62200 hour*microgram per milliliter (h*mcg/ml)
Geometric Coefficient of Variation 31.2
|
114000 hour*microgram per milliliter (h*mcg/ml)
Geometric Coefficient of Variation 9.1
|
144000 hour*microgram per milliliter (h*mcg/ml)
Geometric Coefficient of Variation 14.3
|
60300 hour*microgram per milliliter (h*mcg/ml)
Geometric Coefficient of Variation 27.6
|
24900 hour*microgram per milliliter (h*mcg/ml)
Geometric Coefficient of Variation 33.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0, 1, 4, 10, 25, 72, 168, 240, 336 hours post-dosePopulation: Pharmacokinetic Analysis Set included all participants who received at least 1 dose of IMP, and who provided at least 1 post-baseline sample with a measurable concentration of IMP. Here, 'Overall number of participants analyzed' signifies participants who were evaluable for this outcome measure. As per planned analysis combined PK data was collected for the dose cohorts (\[1 mg/kg +1-1200 mg/kg and 3 mg/kg +HCC-3 mg/kg\]) in dose escalation and 1200mg of all solid tumors in dose expansion.
Terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life is calculated by dividing the natural logarithm to the base e (Log e) multiplied by (\*) 2/ λz, where 'λz' is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Outcome measures
| Measure |
Dose-escalation: M7824 0.3 - 10 mg/kg
n=3 Participants
Participants received a dose of 0.3 mg/kg M7824 IV infusion as a first dose and then switched to a 10 mg/kg as a second dose over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 1 mg/kg
n=6 Participants
Participants received a dose of 1 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs
|
Dose-escalation: M7824 1 - 1200 mg
n=5 Participants
Participants received IV infusion of M7824 1 mg/kg over 1 hour as first dose switched to a 1200 milligram per infusion (mg/infusion) over 1 hour as second dose once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 3 mg/kg
n=5 Participants
Participants received a dose of 3 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs
|
Dose-escalation: M7824 10 mg/kg
n=9 Participants
Participants received a dose of 10 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 20 mg/kg
n=7 Participants
Participants received a dose of 20 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 30 mg/kg
n=3 Participants
Participants received a dose of 30 mg/kg M7824 IV infusion over 2 hours once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 2400 mg/Infusion
n=355 Participants
Participants received a flat dose of 2400 mg/infusion M7824 IV infusion over 2 hours once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs
|
Dose-escalation: HCC-3 mg/kg
n=31 Participants
Participants with Hepatocellular carcinoma (HCC) received a dose of 3 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs
|
Dose-expansion: Squamous Cell Carcinoma of Head and Neck
Participants with Squamous Cell Carcinoma of Head and Neck received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Cervical Cancer
Participants with Cervical Cancer received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC-2L 1200 mg
Participants with NSCLC-2L received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs
|
Dose-expansion: NSCLC-2L 500 mg
Participants with NSCLC-2L received a flat dose of 500 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC Biomarker
Participants with NSCLC Biomarker (who were naïve to the anti-PD-1/anti-PD-L1 class and had relapsed, refractory, or PD following an anti-PD-1 or anti-PD-L1 agent) received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Esophageal Adenocarcinoma
Participants with Esophageal Adenocarcinoma received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Colorectal Carcinoma
Participants with Colorectal Carcinoma received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Triple Negative Breast Cancer
Participants with Triple Negative Breast Cancer received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Glioblastoma
Participants with Glioblastoma received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Squamous Cell Carcinoma of Head and Neck
Participants with Squamous Cell Carcinoma of Head and Neck received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Cervical Cancer
Participants with Cervical Cancer received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC-2L 1200 mg
Participants with NSCLC-2L received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC-2L 500 mg
Participants with NSCLC-2L received a flat dose of 500 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC Biomarker
Participants with NSCLC Biomarker (who were naïve to the anti-PD-1/anti-PD-L1 class and had relapsed, refractory, or PD following an anti-PD-1 or anti-PD-L1 agent) received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Terminal Half Life (t1/2) of M7824
|
74.0 Hour
Geometric Coefficient of Variation 20.9
|
120 Hour
Geometric Coefficient of Variation 16.9
|
125 Hour
Geometric Coefficient of Variation 22.6
|
160 Hour
Geometric Coefficient of Variation 23.0
|
172 Hour
Geometric Coefficient of Variation 30.3
|
171 Hour
Geometric Coefficient of Variation 31.5
|
177 Hour
Geometric Coefficient of Variation 15.8
|
152 Hour
Geometric Coefficient of Variation 23.3
|
145 Hour
Geometric Coefficient of Variation 23.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0 hours (Pre-dose), 1, 4, 10, 25, 72, 168, 240, 336 hours post-dosePopulation: Pharmacokinetic Analysis Set included all participants who received at least 1 dose of IMP, and who provided at least 1 post-baseline sample with a measurable concentration of IMP. Here, 'Overall number of participants analyzed' signifies participants who were evaluable for this outcome measure. As per planned analysis combined PK data was collected for the dose cohorts (\[1 mg/kg +1-1200 mg/kg and 3 mg/kg +HCC-3 mg/kg\]) in dose escalation and 1200mg of all solid tumors in dose expansion.
Ctrough is the plasma concentration of a drug prior to administration.
Outcome measures
| Measure |
Dose-escalation: M7824 0.3 - 10 mg/kg
n=1 Participants
Participants received a dose of 0.3 mg/kg M7824 IV infusion as a first dose and then switched to a 10 mg/kg as a second dose over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 1 mg/kg
n=7 Participants
Participants received a dose of 1 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs
|
Dose-escalation: M7824 1 - 1200 mg
n=8 Participants
Participants received IV infusion of M7824 1 mg/kg over 1 hour as first dose switched to a 1200 milligram per infusion (mg/infusion) over 1 hour as second dose once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 3 mg/kg
n=6 Participants
Participants received a dose of 3 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs
|
Dose-escalation: M7824 10 mg/kg
n=10 Participants
Participants received a dose of 10 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 20 mg/kg
n=7 Participants
Participants received a dose of 20 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 30 mg/kg
n=3 Participants
Participants received a dose of 30 mg/kg M7824 IV infusion over 2 hours once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 2400 mg/Infusion
n=450 Participants
Participants received a flat dose of 2400 mg/infusion M7824 IV infusion over 2 hours once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs
|
Dose-escalation: HCC-3 mg/kg
n=38 Participants
Participants with Hepatocellular carcinoma (HCC) received a dose of 3 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs
|
Dose-expansion: Squamous Cell Carcinoma of Head and Neck
Participants with Squamous Cell Carcinoma of Head and Neck received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Cervical Cancer
Participants with Cervical Cancer received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC-2L 1200 mg
Participants with NSCLC-2L received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs
|
Dose-expansion: NSCLC-2L 500 mg
Participants with NSCLC-2L received a flat dose of 500 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC Biomarker
Participants with NSCLC Biomarker (who were naïve to the anti-PD-1/anti-PD-L1 class and had relapsed, refractory, or PD following an anti-PD-1 or anti-PD-L1 agent) received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Esophageal Adenocarcinoma
Participants with Esophageal Adenocarcinoma received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Colorectal Carcinoma
Participants with Colorectal Carcinoma received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Triple Negative Breast Cancer
Participants with Triple Negative Breast Cancer received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Glioblastoma
Participants with Glioblastoma received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Squamous Cell Carcinoma of Head and Neck
Participants with Squamous Cell Carcinoma of Head and Neck received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Cervical Cancer
Participants with Cervical Cancer received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC-2L 1200 mg
Participants with NSCLC-2L received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC-2L 500 mg
Participants with NSCLC-2L received a flat dose of 500 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC Biomarker
Participants with NSCLC Biomarker (who were naïve to the anti-PD-1/anti-PD-L1 class and had relapsed, refractory, or PD following an anti-PD-1 or anti-PD-L1 agent) received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Trough Plasma Concentration (Ctrough) of M7824
|
NA mcg/mL
Geometric Coefficient of Variation NA
Geometric mean and geometric CV was not estimable.
|
2.92 mcg/mL
Geometric Coefficient of Variation 49.8
|
10.8 mcg/mL
Geometric Coefficient of Variation 32.6
|
44.0 mcg/mL
Geometric Coefficient of Variation 20.8
|
92.8 mcg/mL
Geometric Coefficient of Variation 33.3
|
164 mcg/mL
Geometric Coefficient of Variation 31.2
|
219 mcg/mL
Geometric Coefficient of Variation 33.9
|
75.0 mcg/mL
Geometric Coefficient of Variation 42.0
|
34.8 mcg/mL
Geometric Coefficient of Variation 82.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0 hours (Pre-dose), 1, 4, 10, 25, 72, 168, 240, 336 hours post-dosePopulation: Pharmacokinetic Analysis Set included all participants who received at least 1 dose of IMP, and who provided at least 1 post-baseline sample with a measurable concentration of IMP. Here, 'Overall number of participants analyzed' signifies participants who were evaluable for this outcome measure. As per planned analysis combined PK data was collected for the dose cohorts (\[1 mg/kg +1-1200 mg/kg and 3 mg/kg +HCC-3 mg/kg\]) in dose escalation and 1200mg of all solid tumors in dose expansion.
CL is defined as the time it takes for the study drug to be completely removed from the body's plasma.
Outcome measures
| Measure |
Dose-escalation: M7824 0.3 - 10 mg/kg
n=3 Participants
Participants received a dose of 0.3 mg/kg M7824 IV infusion as a first dose and then switched to a 10 mg/kg as a second dose over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 1 mg/kg
n=6 Participants
Participants received a dose of 1 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs
|
Dose-escalation: M7824 1 - 1200 mg
n=5 Participants
Participants received IV infusion of M7824 1 mg/kg over 1 hour as first dose switched to a 1200 milligram per infusion (mg/infusion) over 1 hour as second dose once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 3 mg/kg
n=5 Participants
Participants received a dose of 3 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs
|
Dose-escalation: M7824 10 mg/kg
n=9 Participants
Participants received a dose of 10 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 20 mg/kg
n=7 Participants
Participants received a dose of 20 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 30 mg/kg
n=3 Participants
Participants received a dose of 30 mg/kg M7824 IV infusion over 2 hours once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 2400 mg/Infusion
n=355 Participants
Participants received a flat dose of 2400 mg/infusion M7824 IV infusion over 2 hours once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs
|
Dose-escalation: HCC-3 mg/kg
n=31 Participants
Participants with Hepatocellular carcinoma (HCC) received a dose of 3 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs
|
Dose-expansion: Squamous Cell Carcinoma of Head and Neck
Participants with Squamous Cell Carcinoma of Head and Neck received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Cervical Cancer
Participants with Cervical Cancer received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC-2L 1200 mg
Participants with NSCLC-2L received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs
|
Dose-expansion: NSCLC-2L 500 mg
Participants with NSCLC-2L received a flat dose of 500 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC Biomarker
Participants with NSCLC Biomarker (who were naïve to the anti-PD-1/anti-PD-L1 class and had relapsed, refractory, or PD following an anti-PD-1 or anti-PD-L1 agent) received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Esophageal Adenocarcinoma
Participants with Esophageal Adenocarcinoma received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Colorectal Carcinoma
Participants with Colorectal Carcinoma received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Triple Negative Breast Cancer
Participants with Triple Negative Breast Cancer received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Glioblastoma
Participants with Glioblastoma received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Squamous Cell Carcinoma of Head and Neck
Participants with Squamous Cell Carcinoma of Head and Neck received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Cervical Cancer
Participants with Cervical Cancer received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC-2L 1200 mg
Participants with NSCLC-2L received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC-2L 500 mg
Participants with NSCLC-2L received a flat dose of 500 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC Biomarker
Participants with NSCLC Biomarker (who were naïve to the anti-PD-1/anti-PD-L1 class and had relapsed, refractory, or PD following an anti-PD-1 or anti-PD-L1 agent) received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Plasma Clearance (CL) of M7824
|
0.388 milliliter per hour per kg(mL/h/kg)
Geometric Coefficient of Variation 30.1
|
0.270 milliliter per hour per kg(mL/h/kg)
Geometric Coefficient of Variation 37.4
|
0.222 milliliter per hour per kg(mL/h/kg)
Geometric Coefficient of Variation 35.2
|
0.235 milliliter per hour per kg(mL/h/kg)
Geometric Coefficient of Variation 11.0
|
0.242 milliliter per hour per kg(mL/h/kg)
Geometric Coefficient of Variation 28.7
|
0.194 milliliter per hour per kg(mL/h/kg)
Geometric Coefficient of Variation 22.6
|
0.201 milliliter per hour per kg(mL/h/kg)
Geometric Coefficient of Variation 14.3
|
0.219 milliliter per hour per kg(mL/h/kg)
Geometric Coefficient of Variation 30.6
|
0.229 milliliter per hour per kg(mL/h/kg)
Geometric Coefficient of Variation 38.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, up to Week 52Population: Immunogenicity Analysis Set included all participants who received at least 1 dose of IMP and who had at least one valid ADA result at any time point.
The detection of antibodies to M7824 was performed using a validated immunoassay method with tiered testing of screening, confirmatory and titration. Number of participants with positive ADA of M7824 were reported.
Outcome measures
| Measure |
Dose-escalation: M7824 0.3 - 10 mg/kg
n=3 Participants
Participants received a dose of 0.3 mg/kg M7824 IV infusion as a first dose and then switched to a 10 mg/kg as a second dose over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 1 mg/kg
n=3 Participants
Participants received a dose of 1 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs
|
Dose-escalation: M7824 1 - 1200 mg
n=4 Participants
Participants received IV infusion of M7824 1 mg/kg over 1 hour as first dose switched to a 1200 milligram per infusion (mg/infusion) over 1 hour as second dose once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 3 mg/kg
n=3 Participants
Participants received a dose of 3 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs
|
Dose-escalation: M7824 10 mg/kg
n=6 Participants
Participants received a dose of 10 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 20 mg/kg
n=10 Participants
Participants received a dose of 20 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 30 mg/kg
n=7 Participants
Participants received a dose of 30 mg/kg M7824 IV infusion over 2 hours once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 2400 mg/Infusion
n=3 Participants
Participants received a flat dose of 2400 mg/infusion M7824 IV infusion over 2 hours once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs
|
Dose-escalation: HCC-3 mg/kg
n=6 Participants
Participants with Hepatocellular carcinoma (HCC) received a dose of 3 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs
|
Dose-expansion: Squamous Cell Carcinoma of Head and Neck
n=38 Participants
Participants with Squamous Cell Carcinoma of Head and Neck received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Cervical Cancer
n=68 Participants
Participants with Cervical Cancer received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC-2L 1200 mg
n=32 Participants
Participants with NSCLC-2L received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs
|
Dose-expansion: NSCLC-2L 500 mg
n=82 Participants
Participants with NSCLC-2L received a flat dose of 500 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC Biomarker
n=36 Participants
Participants with NSCLC Biomarker (who were naïve to the anti-PD-1/anti-PD-L1 class and had relapsed, refractory, or PD following an anti-PD-1 or anti-PD-L1 agent) received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Esophageal Adenocarcinoma
n=30 Participants
Participants with Esophageal Adenocarcinoma received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Colorectal Carcinoma
n=32 Participants
Participants with Colorectal Carcinoma received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Triple Negative Breast Cancer
n=33 Participants
Participants with Triple Negative Breast Cancer received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Glioblastoma
n=35 Participants
Participants with Glioblastoma received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Squamous Cell Carcinoma of Head and Neck
n=32 Participants
Participants with Squamous Cell Carcinoma of Head and Neck received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Cervical Cancer
n=15 Participants
Participants with Cervical Cancer received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC-2L 1200 mg
n=40 Participants
Participants with NSCLC-2L received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC-2L 500 mg
n=40 Participants
Participants with NSCLC-2L received a flat dose of 500 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC Biomarker
n=40 Participants
Participants with NSCLC Biomarker (who were naïve to the anti-PD-1/anti-PD-L1 class and had relapsed, refractory, or PD following an anti-PD-1 or anti-PD-L1 agent) received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Positive Anti-Drug Antibody (ADA) of M7824
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
5 Participants
|
8 Participants
|
24 Participants
|
8 Participants
|
21 Participants
|
10 Participants
|
4 Participants
|
5 Participants
|
7 Participants
|
7 Participants
|
5 Participants
|
3 Participants
|
9 Participants
|
18 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: From date of randomization up to Week 66Population: FAS included all participants who received at least 1 dose of study treatment.
BOR according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 and as adjudicated by the Investigator. BOR is defined as sum of complete response and partial response (CR+PR). For target lesions (TLs), CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the sum of largest diameter (SLD) of the TLs, taking as a reference the baseline SLD.
Outcome measures
| Measure |
Dose-escalation: M7824 0.3 - 10 mg/kg
n=3 Participants
Participants received a dose of 0.3 mg/kg M7824 IV infusion as a first dose and then switched to a 10 mg/kg as a second dose over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 1 mg/kg
n=3 Participants
Participants received a dose of 1 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs
|
Dose-escalation: M7824 1 - 1200 mg
n=4 Participants
Participants received IV infusion of M7824 1 mg/kg over 1 hour as first dose switched to a 1200 milligram per infusion (mg/infusion) over 1 hour as second dose once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 3 mg/kg
n=3 Participants
Participants received a dose of 3 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs
|
Dose-escalation: M7824 10 mg/kg
n=6 Participants
Participants received a dose of 10 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 20 mg/kg
n=10 Participants
Participants received a dose of 20 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 30 mg/kg
n=7 Participants
Participants received a dose of 30 mg/kg M7824 IV infusion over 2 hours once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 2400 mg/Infusion
n=3 Participants
Participants received a flat dose of 2400 mg/infusion M7824 IV infusion over 2 hours once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs
|
Dose-escalation: HCC-3 mg/kg
n=6 Participants
Participants with Hepatocellular carcinoma (HCC) received a dose of 3 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs
|
Dose-expansion: Squamous Cell Carcinoma of Head and Neck
n=38 Participants
Participants with Squamous Cell Carcinoma of Head and Neck received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Cervical Cancer
n=68 Participants
Participants with Cervical Cancer received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC-2L 1200 mg
n=32 Participants
Participants with NSCLC-2L received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs
|
Dose-expansion: NSCLC-2L 500 mg
n=83 Participants
Participants with NSCLC-2L received a flat dose of 500 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC Biomarker
n=36 Participants
Participants with NSCLC Biomarker (who were naïve to the anti-PD-1/anti-PD-L1 class and had relapsed, refractory, or PD following an anti-PD-1 or anti-PD-L1 agent) received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Esophageal Adenocarcinoma
n=30 Participants
Participants with Esophageal Adenocarcinoma received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Colorectal Carcinoma
n=32 Participants
Participants with Colorectal Carcinoma received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Triple Negative Breast Cancer
n=33 Participants
Participants with Triple Negative Breast Cancer received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Glioblastoma
n=35 Participants
Participants with Glioblastoma received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Squamous Cell Carcinoma of Head and Neck
n=32 Participants
Participants with Squamous Cell Carcinoma of Head and Neck received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Cervical Cancer
n=15 Participants
Participants with Cervical Cancer received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC-2L 1200 mg
n=40 Participants
Participants with NSCLC-2L received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC-2L 500 mg
n=40 Participants
Participants with NSCLC-2L received a flat dose of 500 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC Biomarker
n=41 Participants
Participants with NSCLC Biomarker (who were naïve to the anti-PD-1/anti-PD-L1 class and had relapsed, refractory, or PD following an anti-PD-1 or anti-PD-L1 agent) received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Best Overall Response (BOR) as Assessed by Investigator
Complete response
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Best Overall Response (BOR) as Assessed by Investigator
Partial response
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
5 Participants
|
9 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
5 Participants
|
4 Participants
|
10 Participants
|
8 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: From start of study drug administration up to 200 weeksPopulation: SAS included all randomized participants who received at least 1 dose of IMP.
An Adverse Event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. TEAEs were defined as events with onset date or worsening during the on-treatment period. Serious Adverse Event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. Any TEAE included participants with both serious and non-serious AEs.
Outcome measures
| Measure |
Dose-escalation: M7824 0.3 - 10 mg/kg
n=38 Participants
Participants received a dose of 0.3 mg/kg M7824 IV infusion as a first dose and then switched to a 10 mg/kg as a second dose over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 1 mg/kg
n=68 Participants
Participants received a dose of 1 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs
|
Dose-escalation: M7824 1 - 1200 mg
n=32 Participants
Participants received IV infusion of M7824 1 mg/kg over 1 hour as first dose switched to a 1200 milligram per infusion (mg/infusion) over 1 hour as second dose once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 3 mg/kg
n=83 Participants
Participants received a dose of 3 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs
|
Dose-escalation: M7824 10 mg/kg
n=36 Participants
Participants received a dose of 10 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 20 mg/kg
n=30 Participants
Participants received a dose of 20 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 30 mg/kg
n=32 Participants
Participants received a dose of 30 mg/kg M7824 IV infusion over 2 hours once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 2400 mg/Infusion
n=33 Participants
Participants received a flat dose of 2400 mg/infusion M7824 IV infusion over 2 hours once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs
|
Dose-escalation: HCC-3 mg/kg
n=35 Participants
Participants with Hepatocellular carcinoma (HCC) received a dose of 3 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs
|
Dose-expansion: Squamous Cell Carcinoma of Head and Neck
n=32 Participants
Participants with Squamous Cell Carcinoma of Head and Neck received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Cervical Cancer
n=15 Participants
Participants with Cervical Cancer received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC-2L 1200 mg
n=40 Participants
Participants with NSCLC-2L received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs
|
Dose-expansion: NSCLC-2L 500 mg
n=40 Participants
Participants with NSCLC-2L received a flat dose of 500 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC Biomarker
n=41 Participants
Participants with NSCLC Biomarker (who were naïve to the anti-PD-1/anti-PD-L1 class and had relapsed, refractory, or PD following an anti-PD-1 or anti-PD-L1 agent) received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Esophageal Adenocarcinoma
Participants with Esophageal Adenocarcinoma received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Colorectal Carcinoma
Participants with Colorectal Carcinoma received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Triple Negative Breast Cancer
Participants with Triple Negative Breast Cancer received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Glioblastoma
Participants with Glioblastoma received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Squamous Cell Carcinoma of Head and Neck
Participants with Squamous Cell Carcinoma of Head and Neck received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Cervical Cancer
Participants with Cervical Cancer received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC-2L 1200 mg
Participants with NSCLC-2L received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC-2L 500 mg
Participants with NSCLC-2L received a flat dose of 500 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC Biomarker
Participants with NSCLC Biomarker (who were naïve to the anti-PD-1/anti-PD-L1 class and had relapsed, refractory, or PD following an anti-PD-1 or anti-PD-L1 agent) received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Expansion: Number of Participants With TEAEs and Serious TEAEs
Participants with TEAEs
|
38 Participants
|
66 Participants
|
31 Participants
|
82 Participants
|
36 Participants
|
30 Participants
|
32 Participants
|
33 Participants
|
34 Participants
|
31 Participants
|
15 Participants
|
38 Participants
|
37 Participants
|
41 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion: Number of Participants With TEAEs and Serious TEAEs
Participants with Serious TEAEs
|
28 Participants
|
40 Participants
|
14 Participants
|
49 Participants
|
29 Participants
|
21 Participants
|
21 Participants
|
19 Participants
|
19 Participants
|
23 Participants
|
12 Participants
|
21 Participants
|
17 Participants
|
22 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From start of study drug administration up to 200 weeksPopulation: SAS included all randomized participants who received at least 1 dose of study treatment..
Treatment-related TEAEs are any untoward medical occurrence in a participant who received study drug with causal relationship with the investigational product as assessed by the investigator. Related TEAEs were events with relationship missing, unknown or yes. Number of participants with treatment-related TEAEs, treatment-related serious TEAEs and treatment-related TEAE leading to death were reported.
Outcome measures
| Measure |
Dose-escalation: M7824 0.3 - 10 mg/kg
n=38 Participants
Participants received a dose of 0.3 mg/kg M7824 IV infusion as a first dose and then switched to a 10 mg/kg as a second dose over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 1 mg/kg
n=68 Participants
Participants received a dose of 1 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs
|
Dose-escalation: M7824 1 - 1200 mg
n=32 Participants
Participants received IV infusion of M7824 1 mg/kg over 1 hour as first dose switched to a 1200 milligram per infusion (mg/infusion) over 1 hour as second dose once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 3 mg/kg
n=83 Participants
Participants received a dose of 3 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs
|
Dose-escalation: M7824 10 mg/kg
n=36 Participants
Participants received a dose of 10 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 20 mg/kg
n=30 Participants
Participants received a dose of 20 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 30 mg/kg
n=32 Participants
Participants received a dose of 30 mg/kg M7824 IV infusion over 2 hours once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 2400 mg/Infusion
n=33 Participants
Participants received a flat dose of 2400 mg/infusion M7824 IV infusion over 2 hours once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs
|
Dose-escalation: HCC-3 mg/kg
n=35 Participants
Participants with Hepatocellular carcinoma (HCC) received a dose of 3 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs
|
Dose-expansion: Squamous Cell Carcinoma of Head and Neck
n=32 Participants
Participants with Squamous Cell Carcinoma of Head and Neck received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Cervical Cancer
n=15 Participants
Participants with Cervical Cancer received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC-2L 1200 mg
n=40 Participants
Participants with NSCLC-2L received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs
|
Dose-expansion: NSCLC-2L 500 mg
n=40 Participants
Participants with NSCLC-2L received a flat dose of 500 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC Biomarker
n=41 Participants
Participants with NSCLC Biomarker (who were naïve to the anti-PD-1/anti-PD-L1 class and had relapsed, refractory, or PD following an anti-PD-1 or anti-PD-L1 agent) received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Esophageal Adenocarcinoma
Participants with Esophageal Adenocarcinoma received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Colorectal Carcinoma
Participants with Colorectal Carcinoma received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Triple Negative Breast Cancer
Participants with Triple Negative Breast Cancer received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Glioblastoma
Participants with Glioblastoma received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Squamous Cell Carcinoma of Head and Neck
Participants with Squamous Cell Carcinoma of Head and Neck received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Cervical Cancer
Participants with Cervical Cancer received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC-2L 1200 mg
Participants with NSCLC-2L received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC-2L 500 mg
Participants with NSCLC-2L received a flat dose of 500 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC Biomarker
Participants with NSCLC Biomarker (who were naïve to the anti-PD-1/anti-PD-L1 class and had relapsed, refractory, or PD following an anti-PD-1 or anti-PD-L1 agent) received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Expansion: Number of Participants With Treatment-Related TEAEs, Treatment-Related Serious TEAEs and Treatment-related TEAE Leading to Death
Treatment-related TEAEs
|
30 Participants
|
44 Participants
|
24 Participants
|
61 Participants
|
15 Participants
|
20 Participants
|
22 Participants
|
25 Participants
|
25 Participants
|
22 Participants
|
12 Participants
|
28 Participants
|
27 Participants
|
31 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion: Number of Participants With Treatment-Related TEAEs, Treatment-Related Serious TEAEs and Treatment-related TEAE Leading to Death
Treatment-related Serious TEAEs
|
5 Participants
|
10 Participants
|
4 Participants
|
11 Participants
|
2 Participants
|
4 Participants
|
4 Participants
|
8 Participants
|
5 Participants
|
9 Participants
|
3 Participants
|
3 Participants
|
6 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion: Number of Participants With Treatment-Related TEAEs, Treatment-Related Serious TEAEs and Treatment-related TEAE Leading to Death
Treatment-related TEAE leading to death
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From start of study drug administration up to 200 weeksPopulation: SAS included all randomized participants who received at least 1 dose of study treatment.
AEs were graded according to severity using NCI-CTCAE Version 4.03. Severity of TEAEs were graded as Grade 1: mild (not causing any significant problem, dose adjustment not required), Grade 2: moderate (caused problem that does not interfere significantly with usual activities or the clinical status, dose adjustment needed due to adverse event), Grade 3: Severe (caused problem that interferes significantly with usual activities or the clinical status, study drug stopped due to adverse event), Grade 4: Life-threatening, Grade 5: Death. Number of Participants with TEAEs and Related TEAEs Based on Severity having Grade \>= 3 and Grade \>=4 TEAEs were reported.
Outcome measures
| Measure |
Dose-escalation: M7824 0.3 - 10 mg/kg
n=38 Participants
Participants received a dose of 0.3 mg/kg M7824 IV infusion as a first dose and then switched to a 10 mg/kg as a second dose over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 1 mg/kg
n=68 Participants
Participants received a dose of 1 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs
|
Dose-escalation: M7824 1 - 1200 mg
n=32 Participants
Participants received IV infusion of M7824 1 mg/kg over 1 hour as first dose switched to a 1200 milligram per infusion (mg/infusion) over 1 hour as second dose once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 3 mg/kg
n=83 Participants
Participants received a dose of 3 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs
|
Dose-escalation: M7824 10 mg/kg
n=36 Participants
Participants received a dose of 10 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 20 mg/kg
n=30 Participants
Participants received a dose of 20 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 30 mg/kg
n=32 Participants
Participants received a dose of 30 mg/kg M7824 IV infusion over 2 hours once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 2400 mg/Infusion
n=33 Participants
Participants received a flat dose of 2400 mg/infusion M7824 IV infusion over 2 hours once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs
|
Dose-escalation: HCC-3 mg/kg
n=35 Participants
Participants with Hepatocellular carcinoma (HCC) received a dose of 3 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs
|
Dose-expansion: Squamous Cell Carcinoma of Head and Neck
n=32 Participants
Participants with Squamous Cell Carcinoma of Head and Neck received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Cervical Cancer
n=15 Participants
Participants with Cervical Cancer received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC-2L 1200 mg
n=40 Participants
Participants with NSCLC-2L received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs
|
Dose-expansion: NSCLC-2L 500 mg
n=40 Participants
Participants with NSCLC-2L received a flat dose of 500 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC Biomarker
n=41 Participants
Participants with NSCLC Biomarker (who were naïve to the anti-PD-1/anti-PD-L1 class and had relapsed, refractory, or PD following an anti-PD-1 or anti-PD-L1 agent) received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Esophageal Adenocarcinoma
Participants with Esophageal Adenocarcinoma received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Colorectal Carcinoma
Participants with Colorectal Carcinoma received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Triple Negative Breast Cancer
Participants with Triple Negative Breast Cancer received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Glioblastoma
Participants with Glioblastoma received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Squamous Cell Carcinoma of Head and Neck
Participants with Squamous Cell Carcinoma of Head and Neck received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Cervical Cancer
Participants with Cervical Cancer received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC-2L 1200 mg
Participants with NSCLC-2L received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC-2L 500 mg
Participants with NSCLC-2L received a flat dose of 500 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC Biomarker
Participants with NSCLC Biomarker (who were naïve to the anti-PD-1/anti-PD-L1 class and had relapsed, refractory, or PD following an anti-PD-1 or anti-PD-L1 agent) received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Expansion: Number of Participants With TEAEs and Related TEAEs Based on Severity According to NCI-CTCAE Version 4.03
Treatment-related Grade >= 4 TEAE
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion: Number of Participants With TEAEs and Related TEAEs Based on Severity According to NCI-CTCAE Version 4.03
Grade >= 3 TEAE
|
29 Participants
|
52 Participants
|
15 Participants
|
62 Participants
|
31 Participants
|
26 Participants
|
22 Participants
|
20 Participants
|
20 Participants
|
24 Participants
|
14 Participants
|
26 Participants
|
24 Participants
|
27 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion: Number of Participants With TEAEs and Related TEAEs Based on Severity According to NCI-CTCAE Version 4.03
Grade >= 4 TEAE
|
11 Participants
|
13 Participants
|
2 Participants
|
24 Participants
|
9 Participants
|
10 Participants
|
9 Participants
|
11 Participants
|
6 Participants
|
10 Participants
|
1 Participants
|
6 Participants
|
7 Participants
|
10 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion: Number of Participants With TEAEs and Related TEAEs Based on Severity According to NCI-CTCAE Version 4.03
Treatment-related Grade >= 3 TEAE
|
7 Participants
|
17 Participants
|
4 Participants
|
19 Participants
|
6 Participants
|
7 Participants
|
4 Participants
|
6 Participants
|
6 Participants
|
11 Participants
|
3 Participants
|
10 Participants
|
13 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Dose-escalation: M7824 0.3 - 10 mg/kg
Serious events: 2 serious events
Other events: 3 other events
Deaths: 2 deaths
Dose-escalation: M7824 1 mg/kg
Serious events: 2 serious events
Other events: 3 other events
Deaths: 3 deaths
Dose-escalation: M7824 1 - 1200 mg
Serious events: 2 serious events
Other events: 4 other events
Deaths: 4 deaths
Dose-escalation: M7824 10 mg/kg
Serious events: 1 serious events
Other events: 6 other events
Deaths: 3 deaths
Dose-escalation: M7824 20 mg/kg
Serious events: 8 serious events
Other events: 10 other events
Deaths: 8 deaths
Dose-escalation: M7824 2400 mg/Infusion
Serious events: 2 serious events
Other events: 3 other events
Deaths: 2 deaths
Dose-escalation: M7824 3 mg/kg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 3 deaths
Dose-escalation: M7824 30 mg/kg
Serious events: 3 serious events
Other events: 7 other events
Deaths: 3 deaths
Dose-expansion: Cervical Cancer
Serious events: 12 serious events
Other events: 15 other events
Deaths: 8 deaths
Dose-expansion: Colorectal Carcinoma
Serious events: 21 serious events
Other events: 32 other events
Deaths: 23 deaths
Dose-expansion: Esophageal Adenocarcinoma
Serious events: 21 serious events
Other events: 30 other events
Deaths: 26 deaths
Dose-expansion: Glioblastoma
Serious events: 19 serious events
Other events: 34 other events
Deaths: 27 deaths
Dose-expansion: HCC-2L
Serious events: 40 serious events
Other events: 66 other events
Deaths: 53 deaths
Dose-escalation: HCC-3 mg/kg
Serious events: 1 serious events
Other events: 6 other events
Deaths: 6 deaths
Dose-expansion: HCC Ascending Dose 1200mg
Serious events: 28 serious events
Other events: 38 other events
Deaths: 25 deaths
Dose-expansion: Melanoma PD-L1 Fail
Serious events: 14 serious events
Other events: 31 other events
Deaths: 25 deaths
Dose-expansion: NSCLC-2L 1200 mg
Serious events: 21 serious events
Other events: 38 other events
Deaths: 26 deaths
Dose-expansion: NSCLC-2L 500 mg
Serious events: 17 serious events
Other events: 37 other events
Deaths: 30 deaths
Dose-expansion: NSCLC Biomarker
Serious events: 22 serious events
Other events: 41 other events
Deaths: 20 deaths
Dose-expansion: NSCLC PD-L1 Fail
Serious events: 49 serious events
Other events: 82 other events
Deaths: 73 deaths
Dose-expansion: Pancreatic Adenocarcinoma
Serious events: 29 serious events
Other events: 36 other events
Deaths: 29 deaths
Dose-expansion: Squamous Cell Carcinoma of Head and Neck
Serious events: 23 serious events
Other events: 31 other events
Deaths: 22 deaths
Dose-expansion: Triple Negative Breast Cancer
Serious events: 19 serious events
Other events: 33 other events
Deaths: 26 deaths
Serious adverse events
| Measure |
Dose-escalation: M7824 0.3 - 10 mg/kg
n=3 participants at risk
Participants received a dose of 0.3 milligram per kilogram (mg/kg) M7824 intravenous (IV) infusion as a first dose and then switched to a 10 mg/kg as a second dose over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or investigational medicinal product (IMP) occurs.
|
Dose-escalation: M7824 1 mg/kg
n=3 participants at risk
Participants received a dose of 1 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 1 - 1200 mg
n=4 participants at risk
Participants received IV infusion of M7824 1 mg/kg over 1 hour as first dose switched to a 1200 milligram per infusion (mg/infusion) over 1 hour as second dose once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 10 mg/kg
n=6 participants at risk
Participants received a dose of 10 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 20 mg/kg
n=10 participants at risk
Participants received a dose of 20 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 2400 mg/Infusion
n=3 participants at risk
Participants received a flat dose of 2400 mg/infusion M7824 IV infusion over 2 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 3 mg/kg
n=3 participants at risk
Participants received a dose of 3 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 30 mg/kg
n=7 participants at risk
Participants received a dose of 30 mg/kg M7824 IV infusion over 2 hours once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Cervical Cancer
n=15 participants at risk
Participants with Cervical Cancer received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Colorectal Carcinoma
n=32 participants at risk
Participants with Colorectal Carcinoma received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Esophageal Adenocarcinoma
n=30 participants at risk
Participants with Esophageal Adenocarcinoma received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Glioblastoma
n=35 participants at risk
Participants with Glioblastoma received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: HCC-2L
n=68 participants at risk
Subjects with HCC-2L received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: HCC-3 mg/kg
n=6 participants at risk
Participants with Hepatocellular carcinoma (HCC) received a dose of 3 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: HCC Ascending Dose 1200mg
n=38 participants at risk
Subjects with HCC received a flat ascending dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Melanoma PD-L1 Fail
n=32 participants at risk
Participants with Melanoma prior programmed death ligand-1 treatment failure (Melanoma PD-L1 Fail) received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC-2L 1200 mg
n=40 participants at risk
Participants with NSCLC second line (NSCLC-2L) received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC-2L 500 mg
n=40 participants at risk
Participants with NSCLC-2L received a flat dose of 500 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC Biomarker
n=41 participants at risk
Participants with NSCLC Biomarker (who were naïve to the anti-PD-1/anti-PD-L1 class and had relapsed, refractory, or PD following an anti-PD-1 or anti-PD-L1 agent) received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC PD-L1 Fail
n=83 participants at risk
Participants with Non-small Cell Lung Cancer (NSCLC) PD-L1 Fail (must have received and failed platinum-based chemotherapy and must have received anti-PD-1 or anti-PD-L1 as monotherapy and failed with disease progression) received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Pancreatic Adenocarcinoma
n=36 participants at risk
Participants with Pancreatic Adenocarcinoma received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Squamous Cell Carcinoma of Head and Neck
n=32 participants at risk
Participants with Squamous Cell Carcinoma of Head and Neck received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Triple Negative Breast Cancer
n=33 participants at risk
Participants with Triple Negative Breast Cancer received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Haemolysis
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.0%
1/33 • Number of events 1 • From start of study drug administration up to 200 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Infected neoplasm
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intracranial tumour haemorrhage
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
2.9%
1/35 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
30.0%
3/10 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
33.3%
1/3 • Number of events 2 • From start of study drug administration up to 200 weeks
|
14.3%
1/7 • Number of events 2 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 1 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 3 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
4.4%
3/68 • Number of events 3 • From start of study drug administration up to 200 weeks
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
4.9%
2/41 • Number of events 3 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 2 • From start of study drug administration up to 200 weeks
|
8.3%
3/36 • Number of events 3 • From start of study drug administration up to 200 weeks
|
12.5%
4/32 • Number of events 4 • From start of study drug administration up to 200 weeks
|
6.1%
2/33 • Number of events 3 • From start of study drug administration up to 200 weeks
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
5.6%
2/36 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.0%
1/33 • Number of events 1 • From start of study drug administration up to 200 weeks
|
|
Blood and lymphatic system disorders
Thrombotic microangiopathy
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.0%
1/33 • Number of events 2 • From start of study drug administration up to 200 weeks
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.0%
1/33 • Number of events 1 • From start of study drug administration up to 200 weeks
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
2.4%
1/41 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.0%
1/33 • Number of events 1 • From start of study drug administration up to 200 weeks
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.4%
1/41 • Number of events 1 • From start of study drug administration up to 200 weeks
|
2.4%
2/83 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Endocrine disorders
Basedow's disease
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Endocrine disorders
Hypercalcaemia of malignancy
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Endocrine disorders
Hypophysitis
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.0%
1/33 • Number of events 1 • From start of study drug administration up to 200 weeks
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Eye disorders
Blepharospasm
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
2.9%
1/35 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Eye disorders
Vision blurred
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
2.9%
2/68 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
2.8%
1/36 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
33.3%
1/3 • Number of events 1 • From start of study drug administration up to 200 weeks
|
25.0%
1/4 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
20.0%
2/10 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
14.3%
1/7 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
8.3%
3/36 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
2.8%
1/36 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Gastrointestinal disorders
Autoimmune colitis
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
10.0%
1/10 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
2.8%
1/36 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.0%
1/33 • Number of events 1 • From start of study drug administration up to 200 weeks
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 1 • From start of study drug administration up to 200 weeks
|
5.6%
2/36 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
33.3%
1/3 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
10.0%
1/10 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
2.9%
1/35 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
2.8%
1/36 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
2.8%
1/36 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Gastrointestinal disorders
Gastroduodenal haemorrhage
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.4%
1/41 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
5.3%
2/38 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
8.3%
3/36 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Gastrointestinal disorders
Haemorrhagic ascites
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
2.8%
1/36 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Gastrointestinal disorders
Incarcerated inguinal hernia
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Gastrointestinal disorders
Intra-abdominal haematoma
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Gastrointestinal disorders
Intra-abdominal haemorrhage
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
33.3%
1/3 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
33.3%
1/3 • Number of events 6 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 200 weeks
|
10.0%
1/10 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
14.3%
1/7 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
5.3%
2/38 • Number of events 2 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
2.8%
1/36 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
5.3%
2/38 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
10.0%
1/10 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
14.3%
1/7 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
5.6%
2/36 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
33.3%
1/3 • Number of events 6 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 200 weeks
|
10.0%
1/10 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
14.3%
1/7 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
2.9%
1/35 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
5.3%
2/38 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
2.8%
1/36 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.0%
1/33 • Number of events 1 • From start of study drug administration up to 200 weeks
|
|
General disorders
Asthenia
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
2.4%
2/83 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
6.1%
2/33 • Number of events 4 • From start of study drug administration up to 200 weeks
|
|
General disorders
Chest pain
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
2.9%
1/35 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
General disorders
Death
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.4%
1/41 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
General disorders
Disease progression
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
10.0%
1/10 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
12.5%
4/32 • Number of events 5 • From start of study drug administration up to 200 weeks
|
10.0%
3/30 • Number of events 3 • From start of study drug administration up to 200 weeks
|
5.7%
2/35 • Number of events 4 • From start of study drug administration up to 200 weeks
|
2.9%
2/68 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
12.5%
5/40 • Number of events 6 • From start of study drug administration up to 200 weeks
|
10.0%
4/40 • Number of events 4 • From start of study drug administration up to 200 weeks
|
7.3%
3/41 • Number of events 3 • From start of study drug administration up to 200 weeks
|
9.6%
8/83 • Number of events 9 • From start of study drug administration up to 200 weeks
|
5.6%
2/36 • Number of events 2 • From start of study drug administration up to 200 weeks
|
9.4%
3/32 • Number of events 4 • From start of study drug administration up to 200 weeks
|
15.2%
5/33 • Number of events 7 • From start of study drug administration up to 200 weeks
|
|
General disorders
Euthanasia
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
General disorders
Fatigue
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.4%
1/41 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
2.8%
1/36 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
General disorders
General physical health deterioration
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
2.9%
2/68 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
2.4%
2/83 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.0%
1/33 • Number of events 1 • From start of study drug administration up to 200 weeks
|
|
General disorders
Localised oedema
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
33.3%
1/3 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
10.0%
1/10 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
General disorders
Malaise
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
2.9%
1/35 • Number of events 1 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
2.8%
1/36 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.0%
1/33 • Number of events 1 • From start of study drug administration up to 200 weeks
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.4%
1/41 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
2.8%
1/36 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
General disorders
Peripheral swelling
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.0%
1/33 • Number of events 1 • From start of study drug administration up to 200 weeks
|
|
General disorders
Pyrexia
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
10.0%
1/10 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
2.9%
1/35 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.4%
1/41 • Number of events 1 • From start of study drug administration up to 200 weeks
|
2.4%
2/83 • Number of events 2 • From start of study drug administration up to 200 weeks
|
2.8%
1/36 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.0%
1/33 • Number of events 1 • From start of study drug administration up to 200 weeks
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
2.8%
1/36 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
2.8%
1/36 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Hepatobiliary disorders
Hepatic haemorrhage
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Immune system disorders
Anaphylactic shock
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Infections and infestations
Abdominal wall abscess
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Infections and infestations
Appendicitis
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Infections and infestations
Arthritis infective
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
10.0%
1/10 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Infections and infestations
Biliary tract infection
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
2.8%
1/36 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Keratoacanthoma
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
13.3%
2/15 • Number of events 4 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
5.3%
2/38 • Number of events 2 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
2.4%
2/83 • Number of events 5 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 4 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Infections and infestations
Bronchitis
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Infections and infestations
Cystitis
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 1 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Infections and infestations
Device related infection
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
25.0%
1/4 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Infections and infestations
Empyema
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Infections and infestations
Endocarditis staphylococcal
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Infections and infestations
Epiglottitis
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Infections and infestations
Escherichia infection
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Infections and infestations
Fascial infection
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Infections and infestations
Hepatitis A
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Infections and infestations
Implant site infection
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Infections and infestations
Infection
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.4%
1/41 • Number of events 1 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Infections and infestations
Klebsiella infection
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Infections and infestations
Metapneumovirus infection
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
2.9%
1/35 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Infections and infestations
Peritonitis
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Infections and infestations
Pleural infection bacterial
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
25.0%
1/4 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
10.0%
4/40 • Number of events 5 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
2.4%
1/41 • Number of events 1 • From start of study drug administration up to 200 weeks
|
7.2%
6/83 • Number of events 6 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Infections and infestations
Pulmonary sepsis
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.4%
1/41 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
2.4%
2/83 • Number of events 2 • From start of study drug administration up to 200 weeks
|
2.8%
1/36 • Number of events 1 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Infections and infestations
Skin infection
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
33.3%
1/3 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
33.3%
1/3 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
2.9%
1/35 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Infections and infestations
Streptococcal sepsis
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
2.8%
1/36 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Infections and infestations
Viral infection
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
14.3%
1/7 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Injury, poisoning and procedural complications
Extradural haematoma
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
2.9%
1/35 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.4%
1/41 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.0%
1/33 • Number of events 1 • From start of study drug administration up to 200 weeks
|
|
Injury, poisoning and procedural complications
Postoperative respiratory distress
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
25.0%
1/4 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Injury, poisoning and procedural complications
Tracheostomy malfunction
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
5.0%
2/40 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
5.3%
2/38 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
10.0%
1/10 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
3.6%
3/83 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.0%
1/33 • Number of events 1 • From start of study drug administration up to 200 weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
33.3%
1/3 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
10.0%
1/10 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.4%
1/41 • Number of events 2 • From start of study drug administration up to 200 weeks
|
3.6%
3/83 • Number of events 4 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 200 weeks
|
10.0%
1/10 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
2.4%
2/83 • Number of events 2 • From start of study drug administration up to 200 weeks
|
2.8%
1/36 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.4%
1/41 • Number of events 1 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Musculoskeletal and connective tissue disorders
Head deformity
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Musculoskeletal and connective tissue disorders
Hypertrophic osteoarthropathy
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.0%
1/33 • Number of events 1 • From start of study drug administration up to 200 weeks
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
2.9%
1/35 • Number of events 1 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
2.8%
1/36 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Eyelid tumour
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.4%
1/41 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip squamous cell carcinoma
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Liver carcinoma ruptured
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
8.3%
3/36 • Number of events 4 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.4%
1/41 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
25.0%
1/4 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.0%
1/33 • Number of events 1 • From start of study drug administration up to 200 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.0%
1/33 • Number of events 1 • From start of study drug administration up to 200 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to peritoneum
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
2.8%
1/36 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelofibrosis
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
2.8%
1/36 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 1 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 2 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 4 • From start of study drug administration up to 200 weeks
|
2.9%
1/35 • Number of events 1 • From start of study drug administration up to 200 weeks
|
5.9%
4/68 • Number of events 5 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 2 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
2.4%
1/41 • Number of events 1 • From start of study drug administration up to 200 weeks
|
3.6%
3/83 • Number of events 3 • From start of study drug administration up to 200 weeks
|
5.6%
2/36 • Number of events 2 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 2 • From start of study drug administration up to 200 weeks
|
6.1%
2/33 • Number of events 2 • From start of study drug administration up to 200 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the tongue
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
10.0%
3/30 • Number of events 4 • From start of study drug administration up to 200 weeks
|
2.9%
1/35 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
9.4%
3/32 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.4%
1/41 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 2 • From start of study drug administration up to 200 weeks
|
3.0%
1/33 • Number of events 1 • From start of study drug administration up to 200 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour rupture
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
5.7%
2/35 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Nervous system disorders
Central nervous system lesion
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
25.0%
1/4 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Nervous system disorders
Cerebellar haemorrhage
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.4%
1/41 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
10.0%
1/10 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
2.4%
2/83 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.0%
1/33 • Number of events 1 • From start of study drug administration up to 200 weeks
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
10.0%
1/10 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Nervous system disorders
Embolic stroke
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
2.8%
1/36 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
5.7%
2/35 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Nervous system disorders
Haemorrhagic transformation stroke
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
2.8%
1/36 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
2.9%
1/35 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.0%
1/33 • Number of events 1 • From start of study drug administration up to 200 weeks
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
5.7%
2/35 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
2.9%
1/35 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Nervous system disorders
Intracranial pressure increased
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
2.9%
1/35 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Nervous system disorders
Neurological decompensation
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
2.8%
1/36 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Nervous system disorders
Seizure
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
25.0%
1/4 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
2.9%
1/35 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.4%
1/41 • Number of events 1 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
2.9%
1/35 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Nervous system disorders
Vasogenic cerebral oedema
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
2.9%
1/35 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Product Issues
Device occlusion
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
10.0%
1/10 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
5.3%
2/38 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
2.9%
1/35 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 2 • From start of study drug administration up to 200 weeks
|
9.4%
3/32 • Number of events 4 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
5.0%
2/40 • Number of events 2 • From start of study drug administration up to 200 weeks
|
2.4%
1/41 • Number of events 1 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Renal and urinary disorders
Cystitis noninfective
|
33.3%
1/3 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
14.3%
1/7 • Number of events 1 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Renal and urinary disorders
Haematuria
|
33.3%
1/3 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
14.3%
1/7 • Number of events 2 • From start of study drug administration up to 200 weeks
|
20.0%
3/15 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Reproductive system and breast disorders
Breast haemorrhage
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.0%
1/33 • Number of events 1 • From start of study drug administration up to 200 weeks
|
|
Reproductive system and breast disorders
Prostatism
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
2.8%
1/36 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.4%
1/41 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 1 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 3 • From start of study drug administration up to 200 weeks
|
6.7%
2/30 • Number of events 2 • From start of study drug administration up to 200 weeks
|
2.9%
1/35 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
5.3%
2/38 • Number of events 2 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
7.5%
3/40 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
4.9%
2/41 • Number of events 2 • From start of study drug administration up to 200 weeks
|
9.6%
8/83 • Number of events 13 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 3 • From start of study drug administration up to 200 weeks
|
9.1%
3/33 • Number of events 5 • From start of study drug administration up to 200 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
4.9%
2/41 • Number of events 2 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
10.0%
1/10 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Hepatic hydrothorax
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
10.0%
1/10 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
4.9%
2/41 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
2.8%
1/36 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
6.7%
2/30 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
4.4%
3/68 • Number of events 4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
5.0%
2/40 • Number of events 2 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
2.9%
1/35 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
5.0%
2/40 • Number of events 2 • From start of study drug administration up to 200 weeks
|
2.4%
1/41 • Number of events 1 • From start of study drug administration up to 200 weeks
|
4.8%
4/83 • Number of events 4 • From start of study drug administration up to 200 weeks
|
2.8%
1/36 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
25.0%
1/4 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
33.3%
1/3 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
4.9%
2/41 • Number of events 2 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 1 • From start of study drug administration up to 200 weeks
|
2.8%
1/36 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
33.3%
1/3 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Skin and subcutaneous tissue disorders
Lichen planus
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.4%
1/41 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.0%
1/33 • Number of events 1 • From start of study drug administration up to 200 weeks
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
2.8%
1/36 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Surgical and medical procedures
Pain management
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Vascular disorders
Embolism
|
33.3%
1/3 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
25.0%
1/4 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Vascular disorders
Haematoma
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
10.0%
1/10 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
10.0%
1/10 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Vascular disorders
Jugular vein thrombosis
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.0%
1/33 • Number of events 1 • From start of study drug administration up to 200 weeks
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Vascular disorders
Shock
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Vascular disorders
Superior vena cava syndrome
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.4%
1/41 • Number of events 1 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.0%
1/33 • Number of events 1 • From start of study drug administration up to 200 weeks
|
Other adverse events
| Measure |
Dose-escalation: M7824 0.3 - 10 mg/kg
n=3 participants at risk
Participants received a dose of 0.3 milligram per kilogram (mg/kg) M7824 intravenous (IV) infusion as a first dose and then switched to a 10 mg/kg as a second dose over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or investigational medicinal product (IMP) occurs.
|
Dose-escalation: M7824 1 mg/kg
n=3 participants at risk
Participants received a dose of 1 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 1 - 1200 mg
n=4 participants at risk
Participants received IV infusion of M7824 1 mg/kg over 1 hour as first dose switched to a 1200 milligram per infusion (mg/infusion) over 1 hour as second dose once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 10 mg/kg
n=6 participants at risk
Participants received a dose of 10 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 20 mg/kg
n=10 participants at risk
Participants received a dose of 20 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 2400 mg/Infusion
n=3 participants at risk
Participants received a flat dose of 2400 mg/infusion M7824 IV infusion over 2 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 3 mg/kg
n=3 participants at risk
Participants received a dose of 3 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: M7824 30 mg/kg
n=7 participants at risk
Participants received a dose of 30 mg/kg M7824 IV infusion over 2 hours once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Cervical Cancer
n=15 participants at risk
Participants with Cervical Cancer received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Colorectal Carcinoma
n=32 participants at risk
Participants with Colorectal Carcinoma received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Esophageal Adenocarcinoma
n=30 participants at risk
Participants with Esophageal Adenocarcinoma received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Glioblastoma
n=35 participants at risk
Participants with Glioblastoma received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: HCC-2L
n=68 participants at risk
Subjects with HCC-2L received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-escalation: HCC-3 mg/kg
n=6 participants at risk
Participants with Hepatocellular carcinoma (HCC) received a dose of 3 mg/kg M7824 IV infusion over 1 hour once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: HCC Ascending Dose 1200mg
n=38 participants at risk
Subjects with HCC received a flat ascending dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Melanoma PD-L1 Fail
n=32 participants at risk
Participants with Melanoma prior programmed death ligand-1 treatment failure (Melanoma PD-L1 Fail) received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC-2L 1200 mg
n=40 participants at risk
Participants with NSCLC second line (NSCLC-2L) received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC-2L 500 mg
n=40 participants at risk
Participants with NSCLC-2L received a flat dose of 500 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC Biomarker
n=41 participants at risk
Participants with NSCLC Biomarker (who were naïve to the anti-PD-1/anti-PD-L1 class and had relapsed, refractory, or PD following an anti-PD-1 or anti-PD-L1 agent) received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: NSCLC PD-L1 Fail
n=83 participants at risk
Participants with Non-small Cell Lung Cancer (NSCLC) PD-L1 Fail (must have received and failed platinum-based chemotherapy and must have received anti-PD-1 or anti-PD-L1 as monotherapy and failed with disease progression) received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Pancreatic Adenocarcinoma
n=36 participants at risk
Participants with Pancreatic Adenocarcinoma received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Squamous Cell Carcinoma of Head and Neck
n=32 participants at risk
Participants with Squamous Cell Carcinoma of Head and Neck received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
Dose-expansion: Triple Negative Breast Cancer
n=33 participants at risk
Participants with Triple Negative Breast Cancer received a flat dose of 1200 mg M7824 IV infusion once every 2 weeks until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or IMP occurs.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
33.3%
1/3 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
50.0%
2/4 • Number of events 2 • From start of study drug administration up to 200 weeks
|
50.0%
3/6 • Number of events 4 • From start of study drug administration up to 200 weeks
|
20.0%
2/10 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
33.3%
1/3 • Number of events 3 • From start of study drug administration up to 200 weeks
|
28.6%
2/7 • Number of events 2 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 1 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
11.4%
4/35 • Number of events 10 • From start of study drug administration up to 200 weeks
|
11.8%
8/68 • Number of events 25 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
10.5%
4/38 • Number of events 8 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 6 • From start of study drug administration up to 200 weeks
|
30.0%
12/40 • Number of events 29 • From start of study drug administration up to 200 weeks
|
12.5%
5/40 • Number of events 14 • From start of study drug administration up to 200 weeks
|
12.2%
5/41 • Number of events 5 • From start of study drug administration up to 200 weeks
|
7.2%
6/83 • Number of events 12 • From start of study drug administration up to 200 weeks
|
5.6%
2/36 • Number of events 3 • From start of study drug administration up to 200 weeks
|
15.6%
5/32 • Number of events 18 • From start of study drug administration up to 200 weeks
|
3.0%
1/33 • Number of events 1 • From start of study drug administration up to 200 weeks
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
8.6%
3/35 • Number of events 4 • From start of study drug administration up to 200 weeks
|
2.9%
2/68 • Number of events 2 • From start of study drug administration up to 200 weeks
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 200 weeks
|
5.3%
2/38 • Number of events 2 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
2.4%
2/83 • Number of events 5 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.0%
1/33 • Number of events 1 • From start of study drug administration up to 200 weeks
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
13.3%
2/15 • Number of events 3 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 8 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 2 • From start of study drug administration up to 200 weeks
|
16.7%
1/6 • Number of events 2 • From start of study drug administration up to 200 weeks
|
5.3%
2/38 • Number of events 5 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
5.0%
2/40 • Number of events 4 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
3.6%
3/83 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
2.9%
1/35 • Number of events 1 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
5.3%
2/38 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
3.6%
3/83 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
3.0%
1/33 • Number of events 1 • From start of study drug administration up to 200 weeks
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
6.7%
2/30 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 1 • From start of study drug administration up to 200 weeks
|
2.8%
1/36 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.0%
1/33 • Number of events 1 • From start of study drug administration up to 200 weeks
|
|
Skin and subcutaneous tissue disorders
Solar lentigo
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Skin and subcutaneous tissue disorders
Telangiectasia
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
2.4%
2/83 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.0%
1/33 • Number of events 1 • From start of study drug administration up to 200 weeks
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Vascular disorders
Embolism
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
25.0%
1/4 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
10.0%
1/10 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.4%
1/41 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.0%
1/33 • Number of events 1 • From start of study drug administration up to 200 weeks
|
|
Vascular disorders
Flushing
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 3 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Vascular disorders
Hot flush
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
10.0%
1/10 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
14.3%
1/7 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.4%
1/41 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.0%
1/33 • Number of events 2 • From start of study drug administration up to 200 weeks
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
33.3%
1/3 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
10.0%
1/10 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 1 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 2 • From start of study drug administration up to 200 weeks
|
5.7%
2/35 • Number of events 2 • From start of study drug administration up to 200 weeks
|
2.9%
2/68 • Number of events 4 • From start of study drug administration up to 200 weeks
|
33.3%
2/6 • Number of events 2 • From start of study drug administration up to 200 weeks
|
5.3%
2/38 • Number of events 3 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 3 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 2 • From start of study drug administration up to 200 weeks
|
5.0%
2/40 • Number of events 4 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
4.8%
4/83 • Number of events 4 • From start of study drug administration up to 200 weeks
|
5.6%
2/36 • Number of events 4 • From start of study drug administration up to 200 weeks
|
9.4%
3/32 • Number of events 4 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
10.0%
1/10 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 1 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
20.0%
6/30 • Number of events 6 • From start of study drug administration up to 200 weeks
|
2.9%
1/35 • Number of events 1 • From start of study drug administration up to 200 weeks
|
8.8%
6/68 • Number of events 7 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
10.5%
4/38 • Number of events 9 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
5.0%
2/40 • Number of events 2 • From start of study drug administration up to 200 weeks
|
9.8%
4/41 • Number of events 4 • From start of study drug administration up to 200 weeks
|
4.8%
4/83 • Number of events 5 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
3.0%
1/33 • Number of events 1 • From start of study drug administration up to 200 weeks
|
|
Vascular disorders
Pallor
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 1 • From start of study drug administration up to 200 weeks
|
2.8%
1/36 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
5.3%
2/38 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.4%
1/41 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
9.4%
3/32 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
10.3%
7/68 • Number of events 8 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
5.3%
2/38 • Number of events 2 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
4.9%
2/41 • Number of events 2 • From start of study drug administration up to 200 weeks
|
2.4%
2/83 • Number of events 2 • From start of study drug administration up to 200 weeks
|
11.1%
4/36 • Number of events 5 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.0%
1/33 • Number of events 1 • From start of study drug administration up to 200 weeks
|
|
Infections and infestations
Skin infection
|
33.3%
1/3 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
10.0%
1/10 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.0%
1/33 • Number of events 1 • From start of study drug administration up to 200 weeks
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
2.9%
1/35 • Number of events 1 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
5.3%
2/38 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
5.0%
2/40 • Number of events 15 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Infections and infestations
Rhinitis
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
2.8%
1/36 • Number of events 1 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
10.0%
1/10 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
2.9%
1/35 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.4%
1/41 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
2.8%
1/36 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
1/3 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
25.0%
1/4 • Number of events 1 • From start of study drug administration up to 200 weeks
|
33.3%
2/6 • Number of events 2 • From start of study drug administration up to 200 weeks
|
50.0%
5/10 • Number of events 13 • From start of study drug administration up to 200 weeks
|
66.7%
2/3 • Number of events 2 • From start of study drug administration up to 200 weeks
|
33.3%
1/3 • Number of events 5 • From start of study drug administration up to 200 weeks
|
57.1%
4/7 • Number of events 12 • From start of study drug administration up to 200 weeks
|
46.7%
7/15 • Number of events 18 • From start of study drug administration up to 200 weeks
|
31.2%
10/32 • Number of events 32 • From start of study drug administration up to 200 weeks
|
36.7%
11/30 • Number of events 28 • From start of study drug administration up to 200 weeks
|
8.6%
3/35 • Number of events 9 • From start of study drug administration up to 200 weeks
|
35.3%
24/68 • Number of events 58 • From start of study drug administration up to 200 weeks
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 200 weeks
|
23.7%
9/38 • Number of events 16 • From start of study drug administration up to 200 weeks
|
18.8%
6/32 • Number of events 12 • From start of study drug administration up to 200 weeks
|
15.0%
6/40 • Number of events 10 • From start of study drug administration up to 200 weeks
|
22.5%
9/40 • Number of events 19 • From start of study drug administration up to 200 weeks
|
31.7%
13/41 • Number of events 23 • From start of study drug administration up to 200 weeks
|
30.1%
25/83 • Number of events 51 • From start of study drug administration up to 200 weeks
|
33.3%
12/36 • Number of events 29 • From start of study drug administration up to 200 weeks
|
34.4%
11/32 • Number of events 42 • From start of study drug administration up to 200 weeks
|
27.3%
9/33 • Number of events 10 • From start of study drug administration up to 200 weeks
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
4.4%
3/68 • Number of events 11 • From start of study drug administration up to 200 weeks
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
4.4%
3/68 • Number of events 5 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
7.2%
6/83 • Number of events 15 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 1 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
4.4%
3/68 • Number of events 4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.0%
1/33 • Number of events 1 • From start of study drug administration up to 200 weeks
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
10.0%
4/40 • Number of events 4 • From start of study drug administration up to 200 weeks
|
2.4%
1/41 • Number of events 1 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Cardiac disorders
Palpitations
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
4.9%
2/41 • Number of events 2 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 1 • From start of study drug administration up to 200 weeks
|
2.8%
1/36 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.0%
1/33 • Number of events 1 • From start of study drug administration up to 200 weeks
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
10.0%
1/10 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
13.3%
2/15 • Number of events 2 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 2 • From start of study drug administration up to 200 weeks
|
6.7%
2/30 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
5.3%
2/38 • Number of events 6 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
2.4%
1/41 • Number of events 1 • From start of study drug administration up to 200 weeks
|
2.4%
2/83 • Number of events 2 • From start of study drug administration up to 200 weeks
|
2.8%
1/36 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
9.1%
3/33 • Number of events 3 • From start of study drug administration up to 200 weeks
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
2.9%
1/35 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 4 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
14.3%
1/7 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
5.6%
2/36 • Number of events 2 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
10.0%
1/10 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
4.9%
2/41 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Endocrine disorders
Hyperthyroidism
|
33.3%
1/3 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
10.0%
1/10 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
6.7%
2/30 • Number of events 2 • From start of study drug administration up to 200 weeks
|
2.9%
1/35 • Number of events 1 • From start of study drug administration up to 200 weeks
|
4.4%
3/68 • Number of events 5 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
5.3%
2/38 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
9.4%
3/32 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Endocrine disorders
Hypothyroidism
|
33.3%
1/3 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
25.0%
1/4 • Number of events 2 • From start of study drug administration up to 200 weeks
|
33.3%
2/6 • Number of events 3 • From start of study drug administration up to 200 weeks
|
10.0%
1/10 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
14.3%
1/7 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
5.7%
2/35 • Number of events 3 • From start of study drug administration up to 200 weeks
|
5.9%
4/68 • Number of events 4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
13.2%
5/38 • Number of events 5 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
10.0%
4/40 • Number of events 5 • From start of study drug administration up to 200 weeks
|
5.0%
2/40 • Number of events 2 • From start of study drug administration up to 200 weeks
|
4.9%
2/41 • Number of events 2 • From start of study drug administration up to 200 weeks
|
2.4%
2/83 • Number of events 2 • From start of study drug administration up to 200 weeks
|
2.8%
1/36 • Number of events 1 • From start of study drug administration up to 200 weeks
|
21.9%
7/32 • Number of events 9 • From start of study drug administration up to 200 weeks
|
6.1%
2/33 • Number of events 2 • From start of study drug administration up to 200 weeks
|
|
Eye disorders
Cataract
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Eye disorders
Dry eye
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 1 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
2.9%
1/35 • Number of events 1 • From start of study drug administration up to 200 weeks
|
2.9%
2/68 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
5.0%
2/40 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 2 • From start of study drug administration up to 200 weeks
|
3.0%
1/33 • Number of events 1 • From start of study drug administration up to 200 weeks
|
|
Eye disorders
Eye pruritus
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
33.3%
1/3 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
6.7%
2/30 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Eye disorders
Myopia
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Eye disorders
Vision blurred
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
10.0%
3/30 • Number of events 5 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
7.9%
3/38 • Number of events 3 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
3.6%
3/83 • Number of events 3 • From start of study drug administration up to 200 weeks
|
2.8%
1/36 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.0%
1/33 • Number of events 1 • From start of study drug administration up to 200 weeks
|
|
Eye disorders
Vitreous degeneration
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
10.0%
1/10 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
26.7%
4/15 • Number of events 6 • From start of study drug administration up to 200 weeks
|
34.4%
11/32 • Number of events 17 • From start of study drug administration up to 200 weeks
|
16.7%
5/30 • Number of events 6 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
19.1%
13/68 • Number of events 21 • From start of study drug administration up to 200 weeks
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 200 weeks
|
15.8%
6/38 • Number of events 14 • From start of study drug administration up to 200 weeks
|
9.4%
3/32 • Number of events 3 • From start of study drug administration up to 200 weeks
|
15.0%
6/40 • Number of events 6 • From start of study drug administration up to 200 weeks
|
5.0%
2/40 • Number of events 7 • From start of study drug administration up to 200 weeks
|
12.2%
5/41 • Number of events 6 • From start of study drug administration up to 200 weeks
|
7.2%
6/83 • Number of events 8 • From start of study drug administration up to 200 weeks
|
30.6%
11/36 • Number of events 13 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
15.2%
5/33 • Number of events 5 • From start of study drug administration up to 200 weeks
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
2.4%
2/83 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
33.3%
1/3 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
14.3%
1/7 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
6.7%
2/30 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
5.9%
4/68 • Number of events 6 • From start of study drug administration up to 200 weeks
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 200 weeks
|
7.9%
3/38 • Number of events 4 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
7.5%
3/40 • Number of events 3 • From start of study drug administration up to 200 weeks
|
7.3%
3/41 • Number of events 3 • From start of study drug administration up to 200 weeks
|
4.8%
4/83 • Number of events 5 • From start of study drug administration up to 200 weeks
|
5.6%
2/36 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.0%
1/33 • Number of events 1 • From start of study drug administration up to 200 weeks
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
14.3%
1/7 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
5.9%
4/68 • Number of events 5 • From start of study drug administration up to 200 weeks
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 200 weeks
|
5.3%
2/38 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.4%
1/41 • Number of events 1 • From start of study drug administration up to 200 weeks
|
2.4%
2/83 • Number of events 2 • From start of study drug administration up to 200 weeks
|
11.1%
4/36 • Number of events 5 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
14.3%
1/7 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
10.0%
1/10 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
2.9%
1/35 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 2 • From start of study drug administration up to 200 weeks
|
2.4%
1/41 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Number of events 1 • From start of study drug administration up to 200 weeks
|
66.7%
2/3 • Number of events 3 • From start of study drug administration up to 200 weeks
|
25.0%
1/4 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
33.3%
1/3 • Number of events 1 • From start of study drug administration up to 200 weeks
|
42.9%
3/7 • Number of events 3 • From start of study drug administration up to 200 weeks
|
40.0%
6/15 • Number of events 7 • From start of study drug administration up to 200 weeks
|
37.5%
12/32 • Number of events 12 • From start of study drug administration up to 200 weeks
|
26.7%
8/30 • Number of events 9 • From start of study drug administration up to 200 weeks
|
14.3%
5/35 • Number of events 5 • From start of study drug administration up to 200 weeks
|
10.3%
7/68 • Number of events 8 • From start of study drug administration up to 200 weeks
|
66.7%
4/6 • Number of events 4 • From start of study drug administration up to 200 weeks
|
28.9%
11/38 • Number of events 14 • From start of study drug administration up to 200 weeks
|
9.4%
3/32 • Number of events 3 • From start of study drug administration up to 200 weeks
|
5.0%
2/40 • Number of events 5 • From start of study drug administration up to 200 weeks
|
15.0%
6/40 • Number of events 7 • From start of study drug administration up to 200 weeks
|
14.6%
6/41 • Number of events 6 • From start of study drug administration up to 200 weeks
|
18.1%
15/83 • Number of events 20 • From start of study drug administration up to 200 weeks
|
27.8%
10/36 • Number of events 14 • From start of study drug administration up to 200 weeks
|
18.8%
6/32 • Number of events 7 • From start of study drug administration up to 200 weeks
|
18.2%
6/33 • Number of events 7 • From start of study drug administration up to 200 weeks
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
2.9%
1/35 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.4%
1/41 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
33.3%
1/3 • Number of events 4 • From start of study drug administration up to 200 weeks
|
25.0%
1/4 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
10.0%
1/10 • Number of events 2 • From start of study drug administration up to 200 weeks
|
66.7%
2/3 • Number of events 2 • From start of study drug administration up to 200 weeks
|
33.3%
1/3 • Number of events 1 • From start of study drug administration up to 200 weeks
|
28.6%
2/7 • Number of events 2 • From start of study drug administration up to 200 weeks
|
26.7%
4/15 • Number of events 6 • From start of study drug administration up to 200 weeks
|
25.0%
8/32 • Number of events 10 • From start of study drug administration up to 200 weeks
|
16.7%
5/30 • Number of events 5 • From start of study drug administration up to 200 weeks
|
14.3%
5/35 • Number of events 9 • From start of study drug administration up to 200 weeks
|
16.2%
11/68 • Number of events 13 • From start of study drug administration up to 200 weeks
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 200 weeks
|
23.7%
9/38 • Number of events 21 • From start of study drug administration up to 200 weeks
|
15.6%
5/32 • Number of events 6 • From start of study drug administration up to 200 weeks
|
7.5%
3/40 • Number of events 9 • From start of study drug administration up to 200 weeks
|
22.5%
9/40 • Number of events 43 • From start of study drug administration up to 200 weeks
|
22.0%
9/41 • Number of events 16 • From start of study drug administration up to 200 weeks
|
16.9%
14/83 • Number of events 21 • From start of study drug administration up to 200 weeks
|
16.7%
6/36 • Number of events 8 • From start of study drug administration up to 200 weeks
|
12.5%
4/32 • Number of events 8 • From start of study drug administration up to 200 weeks
|
24.2%
8/33 • Number of events 10 • From start of study drug administration up to 200 weeks
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
10.0%
1/10 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
5.7%
2/35 • Number of events 2 • From start of study drug administration up to 200 weeks
|
2.9%
2/68 • Number of events 3 • From start of study drug administration up to 200 weeks
|
33.3%
2/6 • Number of events 2 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
5.0%
2/40 • Number of events 2 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
2.4%
1/41 • Number of events 1 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 1 • From start of study drug administration up to 200 weeks
|
2.8%
1/36 • Number of events 1 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 2 • From start of study drug administration up to 200 weeks
|
6.1%
2/33 • Number of events 2 • From start of study drug administration up to 200 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
10.3%
7/68 • Number of events 7 • From start of study drug administration up to 200 weeks
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 200 weeks
|
5.3%
2/38 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
4.9%
2/41 • Number of events 2 • From start of study drug administration up to 200 weeks
|
3.6%
3/83 • Number of events 4 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.0%
1/33 • Number of events 1 • From start of study drug administration up to 200 weeks
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
33.3%
1/3 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
13.3%
4/30 • Number of events 4 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
2.9%
2/68 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
7.3%
3/41 • Number of events 3 • From start of study drug administration up to 200 weeks
|
2.4%
2/83 • Number of events 2 • From start of study drug administration up to 200 weeks
|
5.6%
2/36 • Number of events 2 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 2 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 2 • From start of study drug administration up to 200 weeks
|
10.0%
3/30 • Number of events 3 • From start of study drug administration up to 200 weeks
|
2.9%
1/35 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.4%
1/41 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
2.8%
1/36 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.4%
1/41 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
5.6%
2/36 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
14.3%
1/7 • Number of events 1 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 1 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 3 • From start of study drug administration up to 200 weeks
|
6.7%
2/30 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
2.9%
2/68 • Number of events 2 • From start of study drug administration up to 200 weeks
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
2.4%
1/41 • Number of events 1 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
33.3%
1/3 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
22.9%
8/35 • Number of events 9 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 200 weeks
|
7.9%
3/38 • Number of events 3 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
2.4%
1/41 • Number of events 1 • From start of study drug administration up to 200 weeks
|
7.2%
6/83 • Number of events 8 • From start of study drug administration up to 200 weeks
|
5.6%
2/36 • Number of events 2 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 2 • From start of study drug administration up to 200 weeks
|
6.1%
2/33 • Number of events 2 • From start of study drug administration up to 200 weeks
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
13.3%
2/15 • Number of events 3 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Gastrointestinal disorders
Haemoperitoneum
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
10.0%
1/10 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
14.3%
1/7 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
2.9%
1/35 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
7.3%
3/41 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
33.3%
1/3 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 2 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
2.9%
1/35 • Number of events 1 • From start of study drug administration up to 200 weeks
|
4.4%
3/68 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Gastrointestinal disorders
Large intestinal haemorrhage
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
20.0%
2/10 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
33.3%
1/3 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
2.8%
1/36 • Number of events 1 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
6.7%
2/30 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
7.4%
5/68 • Number of events 5 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
2.8%
1/36 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
25.0%
1/4 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
30.0%
3/10 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
7.3%
3/41 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Number of events 1 • From start of study drug administration up to 200 weeks
|
66.7%
2/3 • Number of events 2 • From start of study drug administration up to 200 weeks
|
25.0%
1/4 • Number of events 2 • From start of study drug administration up to 200 weeks
|
16.7%
1/6 • Number of events 2 • From start of study drug administration up to 200 weeks
|
30.0%
3/10 • Number of events 4 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
66.7%
2/3 • Number of events 3 • From start of study drug administration up to 200 weeks
|
14.3%
1/7 • Number of events 2 • From start of study drug administration up to 200 weeks
|
20.0%
3/15 • Number of events 6 • From start of study drug administration up to 200 weeks
|
37.5%
12/32 • Number of events 14 • From start of study drug administration up to 200 weeks
|
20.0%
6/30 • Number of events 14 • From start of study drug administration up to 200 weeks
|
11.4%
4/35 • Number of events 6 • From start of study drug administration up to 200 weeks
|
22.1%
15/68 • Number of events 18 • From start of study drug administration up to 200 weeks
|
16.7%
1/6 • Number of events 3 • From start of study drug administration up to 200 weeks
|
31.6%
12/38 • Number of events 29 • From start of study drug administration up to 200 weeks
|
21.9%
7/32 • Number of events 10 • From start of study drug administration up to 200 weeks
|
10.0%
4/40 • Number of events 7 • From start of study drug administration up to 200 weeks
|
25.0%
10/40 • Number of events 16 • From start of study drug administration up to 200 weeks
|
22.0%
9/41 • Number of events 11 • From start of study drug administration up to 200 weeks
|
13.3%
11/83 • Number of events 15 • From start of study drug administration up to 200 weeks
|
27.8%
10/36 • Number of events 15 • From start of study drug administration up to 200 weeks
|
12.5%
4/32 • Number of events 6 • From start of study drug administration up to 200 weeks
|
15.2%
5/33 • Number of events 6 • From start of study drug administration up to 200 weeks
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
2.9%
1/35 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.0%
1/33 • Number of events 1 • From start of study drug administration up to 200 weeks
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.4%
1/41 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 6 • From start of study drug administration up to 200 weeks
|
3.0%
1/33 • Number of events 1 • From start of study drug administration up to 200 weeks
|
|
Gastrointestinal disorders
Periodontal disease
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
7.5%
3/40 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
14.3%
1/7 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
33.3%
1/3 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
33.3%
1/3 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 2 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
5.0%
2/40 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.0%
1/33 • Number of events 1 • From start of study drug administration up to 200 weeks
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
20.0%
2/10 • Number of events 6 • From start of study drug administration up to 200 weeks
|
33.3%
1/3 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
2.9%
1/35 • Number of events 1 • From start of study drug administration up to 200 weeks
|
4.4%
3/68 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 3 • From start of study drug administration up to 200 weeks
|
7.5%
3/40 • Number of events 7 • From start of study drug administration up to 200 weeks
|
10.0%
4/40 • Number of events 4 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
3.6%
3/83 • Number of events 4 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
15.6%
5/32 • Number of events 7 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Gastrointestinal disorders
Tongue ulceration
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
14.3%
1/7 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.4%
1/41 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
2.8%
1/36 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Number of events 1 • From start of study drug administration up to 200 weeks
|
66.7%
2/3 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 200 weeks
|
10.0%
1/10 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
66.7%
2/3 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
26.7%
4/15 • Number of events 5 • From start of study drug administration up to 200 weeks
|
21.9%
7/32 • Number of events 7 • From start of study drug administration up to 200 weeks
|
23.3%
7/30 • Number of events 10 • From start of study drug administration up to 200 weeks
|
11.4%
4/35 • Number of events 5 • From start of study drug administration up to 200 weeks
|
13.2%
9/68 • Number of events 11 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
21.1%
8/38 • Number of events 23 • From start of study drug administration up to 200 weeks
|
9.4%
3/32 • Number of events 3 • From start of study drug administration up to 200 weeks
|
7.5%
3/40 • Number of events 4 • From start of study drug administration up to 200 weeks
|
15.0%
6/40 • Number of events 7 • From start of study drug administration up to 200 weeks
|
19.5%
8/41 • Number of events 11 • From start of study drug administration up to 200 weeks
|
9.6%
8/83 • Number of events 11 • From start of study drug administration up to 200 weeks
|
22.2%
8/36 • Number of events 10 • From start of study drug administration up to 200 weeks
|
9.4%
3/32 • Number of events 9 • From start of study drug administration up to 200 weeks
|
12.1%
4/33 • Number of events 5 • From start of study drug administration up to 200 weeks
|
|
General disorders
Asthenia
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
13.3%
2/15 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
20.0%
6/30 • Number of events 10 • From start of study drug administration up to 200 weeks
|
20.0%
7/35 • Number of events 8 • From start of study drug administration up to 200 weeks
|
19.1%
13/68 • Number of events 21 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
15.8%
6/38 • Number of events 8 • From start of study drug administration up to 200 weeks
|
15.6%
5/32 • Number of events 9 • From start of study drug administration up to 200 weeks
|
15.0%
6/40 • Number of events 7 • From start of study drug administration up to 200 weeks
|
20.0%
8/40 • Number of events 13 • From start of study drug administration up to 200 weeks
|
9.8%
4/41 • Number of events 5 • From start of study drug administration up to 200 weeks
|
38.6%
32/83 • Number of events 79 • From start of study drug administration up to 200 weeks
|
5.6%
2/36 • Number of events 5 • From start of study drug administration up to 200 weeks
|
31.2%
10/32 • Number of events 16 • From start of study drug administration up to 200 weeks
|
21.2%
7/33 • Number of events 13 • From start of study drug administration up to 200 weeks
|
|
General disorders
Chest pain
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 1 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
2.9%
1/35 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
5.0%
2/40 • Number of events 2 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
2.4%
2/83 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
6.1%
2/33 • Number of events 2 • From start of study drug administration up to 200 weeks
|
|
General disorders
Chills
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
14.3%
1/7 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
2.9%
1/35 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
7.9%
3/38 • Number of events 6 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
4.9%
2/41 • Number of events 2 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 2 • From start of study drug administration up to 200 weeks
|
8.3%
3/36 • Number of events 4 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
General disorders
Cyst
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
5.7%
2/35 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.4%
1/41 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
General disorders
Face oedema
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.4%
1/41 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
General disorders
Facial pain
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
General disorders
Fatigue
|
33.3%
1/3 • Number of events 1 • From start of study drug administration up to 200 weeks
|
100.0%
3/3 • Number of events 4 • From start of study drug administration up to 200 weeks
|
100.0%
4/4 • Number of events 6 • From start of study drug administration up to 200 weeks
|
33.3%
2/6 • Number of events 3 • From start of study drug administration up to 200 weeks
|
60.0%
6/10 • Number of events 9 • From start of study drug administration up to 200 weeks
|
66.7%
2/3 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
57.1%
4/7 • Number of events 4 • From start of study drug administration up to 200 weeks
|
33.3%
5/15 • Number of events 8 • From start of study drug administration up to 200 weeks
|
37.5%
12/32 • Number of events 14 • From start of study drug administration up to 200 weeks
|
30.0%
9/30 • Number of events 14 • From start of study drug administration up to 200 weeks
|
14.3%
5/35 • Number of events 7 • From start of study drug administration up to 200 weeks
|
23.5%
16/68 • Number of events 20 • From start of study drug administration up to 200 weeks
|
50.0%
3/6 • Number of events 7 • From start of study drug administration up to 200 weeks
|
50.0%
19/38 • Number of events 39 • From start of study drug administration up to 200 weeks
|
31.2%
10/32 • Number of events 10 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 3 • From start of study drug administration up to 200 weeks
|
15.0%
6/40 • Number of events 11 • From start of study drug administration up to 200 weeks
|
24.4%
10/41 • Number of events 17 • From start of study drug administration up to 200 weeks
|
19.3%
16/83 • Number of events 45 • From start of study drug administration up to 200 weeks
|
33.3%
12/36 • Number of events 15 • From start of study drug administration up to 200 weeks
|
12.5%
4/32 • Number of events 4 • From start of study drug administration up to 200 weeks
|
9.1%
3/33 • Number of events 4 • From start of study drug administration up to 200 weeks
|
|
General disorders
Gait disturbance
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
5.7%
2/35 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
2.4%
1/41 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
General disorders
General physical health deterioration
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
6.7%
2/30 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
2.9%
2/68 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
5.0%
2/40 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
3.6%
3/83 • Number of events 4 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
9.1%
3/33 • Number of events 3 • From start of study drug administration up to 200 weeks
|
|
General disorders
Generalised oedema
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
General disorders
Influenza like illness
|
33.3%
1/3 • Number of events 1 • From start of study drug administration up to 200 weeks
|
33.3%
1/3 • Number of events 1 • From start of study drug administration up to 200 weeks
|
50.0%
2/4 • Number of events 2 • From start of study drug administration up to 200 weeks
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
4.4%
3/68 • Number of events 5 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
5.3%
2/38 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 2 • From start of study drug administration up to 200 weeks
|
4.9%
2/41 • Number of events 3 • From start of study drug administration up to 200 weeks
|
3.6%
3/83 • Number of events 3 • From start of study drug administration up to 200 weeks
|
2.8%
1/36 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.0%
1/33 • Number of events 1 • From start of study drug administration up to 200 weeks
|
|
General disorders
Infusion site irritation
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
10.0%
1/10 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
General disorders
Localised oedema
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
33.3%
1/3 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
33.3%
1/3 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 1 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
General disorders
Malaise
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 1 • From start of study drug administration up to 200 weeks
|
9.4%
3/32 • Number of events 3 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
2.9%
1/35 • Number of events 1 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
5.3%
2/38 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
3.6%
3/83 • Number of events 5 • From start of study drug administration up to 200 weeks
|
5.6%
2/36 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.0%
1/33 • Number of events 1 • From start of study drug administration up to 200 weeks
|
|
General disorders
Mucosal inflammation
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
4.4%
3/68 • Number of events 6 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
5.3%
2/38 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 1 • From start of study drug administration up to 200 weeks
|
2.8%
1/36 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.0%
1/33 • Number of events 1 • From start of study drug administration up to 200 weeks
|
|
General disorders
Nodule
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
2.8%
1/36 • Number of events 1 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
33.3%
1/3 • Number of events 1 • From start of study drug administration up to 200 weeks
|
50.0%
2/4 • Number of events 2 • From start of study drug administration up to 200 weeks
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 200 weeks
|
10.0%
1/10 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
7.5%
3/40 • Number of events 5 • From start of study drug administration up to 200 weeks
|
12.2%
5/41 • Number of events 6 • From start of study drug administration up to 200 weeks
|
9.6%
8/83 • Number of events 8 • From start of study drug administration up to 200 weeks
|
2.8%
1/36 • Number of events 1 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
3.0%
1/33 • Number of events 1 • From start of study drug administration up to 200 weeks
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
10.0%
1/10 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
13.3%
2/15 • Number of events 3 • From start of study drug administration up to 200 weeks
|
9.4%
3/32 • Number of events 4 • From start of study drug administration up to 200 weeks
|
26.7%
8/30 • Number of events 8 • From start of study drug administration up to 200 weeks
|
11.4%
4/35 • Number of events 4 • From start of study drug administration up to 200 weeks
|
13.2%
9/68 • Number of events 13 • From start of study drug administration up to 200 weeks
|
33.3%
2/6 • Number of events 3 • From start of study drug administration up to 200 weeks
|
23.7%
9/38 • Number of events 11 • From start of study drug administration up to 200 weeks
|
9.4%
3/32 • Number of events 5 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
9.8%
4/41 • Number of events 4 • From start of study drug administration up to 200 weeks
|
7.2%
6/83 • Number of events 8 • From start of study drug administration up to 200 weeks
|
19.4%
7/36 • Number of events 7 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 3 • From start of study drug administration up to 200 weeks
|
9.1%
3/33 • Number of events 4 • From start of study drug administration up to 200 weeks
|
|
General disorders
Pain
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 2 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
2.9%
2/68 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 2 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
5.0%
2/40 • Number of events 2 • From start of study drug administration up to 200 weeks
|
2.4%
1/41 • Number of events 1 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 1 • From start of study drug administration up to 200 weeks
|
2.8%
1/36 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
General disorders
Peripheral swelling
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.4%
1/41 • Number of events 1 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
6.1%
2/33 • Number of events 3 • From start of study drug administration up to 200 weeks
|
|
General disorders
Pyrexia
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
66.7%
2/3 • Number of events 2 • From start of study drug administration up to 200 weeks
|
25.0%
1/4 • Number of events 1 • From start of study drug administration up to 200 weeks
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 200 weeks
|
20.0%
2/10 • Number of events 2 • From start of study drug administration up to 200 weeks
|
33.3%
1/3 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
14.3%
1/7 • Number of events 1 • From start of study drug administration up to 200 weeks
|
13.3%
2/15 • Number of events 2 • From start of study drug administration up to 200 weeks
|
21.9%
7/32 • Number of events 9 • From start of study drug administration up to 200 weeks
|
6.7%
2/30 • Number of events 3 • From start of study drug administration up to 200 weeks
|
2.9%
1/35 • Number of events 1 • From start of study drug administration up to 200 weeks
|
8.8%
6/68 • Number of events 8 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
36.8%
14/38 • Number of events 21 • From start of study drug administration up to 200 weeks
|
9.4%
3/32 • Number of events 6 • From start of study drug administration up to 200 weeks
|
22.5%
9/40 • Number of events 11 • From start of study drug administration up to 200 weeks
|
17.5%
7/40 • Number of events 10 • From start of study drug administration up to 200 weeks
|
14.6%
6/41 • Number of events 7 • From start of study drug administration up to 200 weeks
|
12.0%
10/83 • Number of events 10 • From start of study drug administration up to 200 weeks
|
22.2%
8/36 • Number of events 15 • From start of study drug administration up to 200 weeks
|
25.0%
8/32 • Number of events 15 • From start of study drug administration up to 200 weeks
|
24.2%
8/33 • Number of events 11 • From start of study drug administration up to 200 weeks
|
|
General disorders
Suprapubic pain
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
2.9%
2/68 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
5.3%
2/38 • Number of events 2 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 3 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
4.4%
3/68 • Number of events 5 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
7.9%
3/38 • Number of events 4 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Immune system disorders
Contrast media allergy
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Infections and infestations
Anorectal infection
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
25.0%
1/4 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Infections and infestations
Arthritis infective
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
10.0%
1/10 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Infections and infestations
Bronchitis
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 2 • From start of study drug administration up to 200 weeks
|
6.7%
2/30 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 200 weeks
|
5.3%
2/38 • Number of events 2 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
7.5%
3/40 • Number of events 3 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 2 • From start of study drug administration up to 200 weeks
|
2.4%
1/41 • Number of events 1 • From start of study drug administration up to 200 weeks
|
2.4%
2/83 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
9.4%
3/32 • Number of events 4 • From start of study drug administration up to 200 weeks
|
3.0%
1/33 • Number of events 1 • From start of study drug administration up to 200 weeks
|
|
Infections and infestations
Candida infection
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.4%
1/41 • Number of events 1 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 1 • From start of study drug administration up to 200 weeks
|
2.8%
1/36 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
33.3%
1/3 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
4.4%
3/68 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
4.9%
2/41 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Infections and infestations
Device related infection
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
10.0%
3/30 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.4%
1/41 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Infections and infestations
Eye infection
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Infections and infestations
Folliculitis
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
8.6%
3/35 • Number of events 3 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
5.3%
2/38 • Number of events 7 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
5.0%
2/40 • Number of events 2 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 5 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
3.6%
3/83 • Number of events 5 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
9.4%
3/32 • Number of events 4 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Infections and infestations
Gingivitis
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Infections and infestations
Influenza
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
2.9%
1/35 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
7.9%
3/38 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
3.6%
3/83 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Infections and infestations
Lip infection
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
10.0%
1/10 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Infections and infestations
Nail infection
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
10.0%
1/10 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 2 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
4.9%
2/41 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
6.1%
2/33 • Number of events 2 • From start of study drug administration up to 200 weeks
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
5.3%
2/38 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Infections and infestations
Oral fungal infection
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
6.1%
2/33 • Number of events 2 • From start of study drug administration up to 200 weeks
|
|
Infections and infestations
Oral herpes
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
2.9%
2/68 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
6.1%
2/33 • Number of events 2 • From start of study drug administration up to 200 weeks
|
|
Infections and infestations
Paronychia
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
10.0%
1/10 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
33.3%
1/3 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 2 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
2.9%
2/68 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
5.3%
2/38 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
5.0%
2/40 • Number of events 2 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 2 • From start of study drug administration up to 200 weeks
|
4.9%
2/41 • Number of events 2 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 1 • From start of study drug administration up to 200 weeks
|
5.6%
2/36 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
5.3%
2/38 • Number of events 6 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
2.9%
1/35 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
6.1%
2/33 • Number of events 2 • From start of study drug administration up to 200 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
33.3%
1/3 • Number of events 1 • From start of study drug administration up to 200 weeks
|
25.0%
1/4 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
13.3%
2/15 • Number of events 2 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 2 • From start of study drug administration up to 200 weeks
|
6.7%
2/30 • Number of events 2 • From start of study drug administration up to 200 weeks
|
5.7%
2/35 • Number of events 2 • From start of study drug administration up to 200 weeks
|
2.9%
2/68 • Number of events 2 • From start of study drug administration up to 200 weeks
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 200 weeks
|
7.9%
3/38 • Number of events 3 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
5.0%
2/40 • Number of events 2 • From start of study drug administration up to 200 weeks
|
7.5%
3/40 • Number of events 4 • From start of study drug administration up to 200 weeks
|
4.9%
2/41 • Number of events 2 • From start of study drug administration up to 200 weeks
|
2.4%
2/83 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
12.1%
4/33 • Number of events 4 • From start of study drug administration up to 200 weeks
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
10.0%
1/10 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
13.3%
2/15 • Number of events 3 • From start of study drug administration up to 200 weeks
|
21.9%
7/32 • Number of events 9 • From start of study drug administration up to 200 weeks
|
6.7%
2/30 • Number of events 3 • From start of study drug administration up to 200 weeks
|
2.9%
1/35 • Number of events 1 • From start of study drug administration up to 200 weeks
|
4.4%
3/68 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
10.5%
4/38 • Number of events 4 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
5.0%
2/40 • Number of events 2 • From start of study drug administration up to 200 weeks
|
5.0%
2/40 • Number of events 3 • From start of study drug administration up to 200 weeks
|
2.4%
1/41 • Number of events 1 • From start of study drug administration up to 200 weeks
|
9.6%
8/83 • Number of events 8 • From start of study drug administration up to 200 weeks
|
8.3%
3/36 • Number of events 3 • From start of study drug administration up to 200 weeks
|
9.4%
3/32 • Number of events 3 • From start of study drug administration up to 200 weeks
|
3.0%
1/33 • Number of events 1 • From start of study drug administration up to 200 weeks
|
|
Infections and infestations
Viral infection
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
13.3%
2/15 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Infections and infestations
Wound infection
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
10.0%
1/10 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
20.0%
3/15 • Number of events 8 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
6.7%
2/30 • Number of events 3 • From start of study drug administration up to 200 weeks
|
5.7%
2/35 • Number of events 5 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 8 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
3.6%
3/83 • Number of events 10 • From start of study drug administration up to 200 weeks
|
2.8%
1/36 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Injury, poisoning and procedural complications
Arterial injury
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
10.0%
1/10 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
25.0%
1/4 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
5.7%
2/35 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
5.3%
2/38 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 1 • From start of study drug administration up to 200 weeks
|
2.8%
1/36 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.0%
1/33 • Number of events 3 • From start of study drug administration up to 200 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 200 weeks
|
10.0%
1/10 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
6.7%
2/30 • Number of events 2 • From start of study drug administration up to 200 weeks
|
8.6%
3/35 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
5.0%
2/40 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 1 • From start of study drug administration up to 200 weeks
|
2.8%
1/36 • Number of events 3 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 200 weeks
|
10.0%
1/10 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
42.9%
3/7 • Number of events 4 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
15.6%
5/32 • Number of events 6 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
2.9%
1/35 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.4%
1/41 • Number of events 1 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 1 • From start of study drug administration up to 200 weeks
|
5.6%
2/36 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
6.1%
2/33 • Number of events 3 • From start of study drug administration up to 200 weeks
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
2.9%
1/35 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.4%
1/41 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Injury, poisoning and procedural complications
Stoma site haemorrhage
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
33.3%
1/3 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
14.3%
1/7 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
2.9%
1/35 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
10.0%
1/10 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
33.3%
1/3 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.4%
1/41 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
33.3%
1/3 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
13.3%
2/15 • Number of events 2 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
13.3%
4/30 • Number of events 4 • From start of study drug administration up to 200 weeks
|
5.7%
2/35 • Number of events 3 • From start of study drug administration up to 200 weeks
|
16.2%
11/68 • Number of events 20 • From start of study drug administration up to 200 weeks
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 200 weeks
|
7.9%
3/38 • Number of events 6 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
7.5%
3/40 • Number of events 13 • From start of study drug administration up to 200 weeks
|
7.5%
3/40 • Number of events 12 • From start of study drug administration up to 200 weeks
|
2.4%
1/41 • Number of events 1 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 2 • From start of study drug administration up to 200 weeks
|
11.1%
4/36 • Number of events 4 • From start of study drug administration up to 200 weeks
|
12.5%
4/32 • Number of events 8 • From start of study drug administration up to 200 weeks
|
9.1%
3/33 • Number of events 3 • From start of study drug administration up to 200 weeks
|
|
Investigations
Alpha 1 foetoprotein increased
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Investigations
Amylase increased
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
25.0%
1/4 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
10.0%
1/10 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
14.3%
1/7 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
2.9%
1/35 • Number of events 4 • From start of study drug administration up to 200 weeks
|
2.9%
2/68 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 4 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
7.5%
3/40 • Number of events 11 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
2.4%
1/41 • Number of events 1 • From start of study drug administration up to 200 weeks
|
3.6%
3/83 • Number of events 4 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.0%
1/33 • Number of events 1 • From start of study drug administration up to 200 weeks
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
25.0%
1/4 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
12.5%
4/32 • Number of events 6 • From start of study drug administration up to 200 weeks
|
10.0%
3/30 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
25.0%
17/68 • Number of events 27 • From start of study drug administration up to 200 weeks
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 200 weeks
|
21.1%
8/38 • Number of events 12 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
7.5%
3/40 • Number of events 11 • From start of study drug administration up to 200 weeks
|
7.5%
3/40 • Number of events 9 • From start of study drug administration up to 200 weeks
|
4.9%
2/41 • Number of events 2 • From start of study drug administration up to 200 weeks
|
3.6%
3/83 • Number of events 4 • From start of study drug administration up to 200 weeks
|
19.4%
7/36 • Number of events 7 • From start of study drug administration up to 200 weeks
|
15.6%
5/32 • Number of events 10 • From start of study drug administration up to 200 weeks
|
18.2%
6/33 • Number of events 7 • From start of study drug administration up to 200 weeks
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
33.3%
1/3 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
9.4%
3/32 • Number of events 3 • From start of study drug administration up to 200 weeks
|
6.7%
2/30 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
7.4%
5/68 • Number of events 5 • From start of study drug administration up to 200 weeks
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 200 weeks
|
15.8%
6/38 • Number of events 9 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
5.0%
2/40 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
9.8%
4/41 • Number of events 6 • From start of study drug administration up to 200 weeks
|
8.4%
7/83 • Number of events 10 • From start of study drug administration up to 200 weeks
|
2.8%
1/36 • Number of events 1 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 4 • From start of study drug administration up to 200 weeks
|
6.1%
2/33 • Number of events 3 • From start of study drug administration up to 200 weeks
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 2 • From start of study drug administration up to 200 weeks
|
10.0%
3/30 • Number of events 4 • From start of study drug administration up to 200 weeks
|
5.7%
2/35 • Number of events 4 • From start of study drug administration up to 200 weeks
|
10.3%
7/68 • Number of events 11 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
7.9%
3/38 • Number of events 5 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.4%
1/41 • Number of events 1 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 1 • From start of study drug administration up to 200 weeks
|
8.3%
3/36 • Number of events 6 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 2 • From start of study drug administration up to 200 weeks
|
6.1%
2/33 • Number of events 2 • From start of study drug administration up to 200 weeks
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
2.9%
2/68 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
5.3%
2/38 • Number of events 9 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
4.9%
2/41 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
9.4%
3/32 • Number of events 4 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Investigations
Blood creatinine increased
|
33.3%
1/3 • Number of events 1 • From start of study drug administration up to 200 weeks
|
66.7%
2/3 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
20.0%
2/10 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
14.3%
1/7 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
4.4%
3/68 • Number of events 4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
7.9%
3/38 • Number of events 5 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
7.3%
3/41 • Number of events 5 • From start of study drug administration up to 200 weeks
|
4.8%
4/83 • Number of events 10 • From start of study drug administration up to 200 weeks
|
2.8%
1/36 • Number of events 2 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
3.0%
1/33 • Number of events 1 • From start of study drug administration up to 200 weeks
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
5.3%
2/38 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Investigations
CD4 lymphocytes decreased
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 200 weeks
|
10.0%
1/10 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
25.0%
1/4 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
28.6%
2/7 • Number of events 2 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 2 • From start of study drug administration up to 200 weeks
|
9.4%
3/32 • Number of events 3 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
14.7%
10/68 • Number of events 14 • From start of study drug administration up to 200 weeks
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 200 weeks
|
7.9%
3/38 • Number of events 4 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 2 • From start of study drug administration up to 200 weeks
|
5.0%
2/40 • Number of events 10 • From start of study drug administration up to 200 weeks
|
5.0%
2/40 • Number of events 3 • From start of study drug administration up to 200 weeks
|
12.2%
5/41 • Number of events 5 • From start of study drug administration up to 200 weeks
|
12.0%
10/83 • Number of events 18 • From start of study drug administration up to 200 weeks
|
5.6%
2/36 • Number of events 2 • From start of study drug administration up to 200 weeks
|
12.5%
4/32 • Number of events 19 • From start of study drug administration up to 200 weeks
|
3.0%
1/33 • Number of events 1 • From start of study drug administration up to 200 weeks
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.0%
1/33 • Number of events 5 • From start of study drug administration up to 200 weeks
|
|
Investigations
Lipase increased
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
20.0%
2/10 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
14.3%
1/7 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
2.9%
1/35 • Number of events 15 • From start of study drug administration up to 200 weeks
|
5.9%
4/68 • Number of events 6 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
13.2%
5/38 • Number of events 22 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
10.0%
4/40 • Number of events 8 • From start of study drug administration up to 200 weeks
|
7.5%
3/40 • Number of events 7 • From start of study drug administration up to 200 weeks
|
4.9%
2/41 • Number of events 4 • From start of study drug administration up to 200 weeks
|
2.4%
2/83 • Number of events 5 • From start of study drug administration up to 200 weeks
|
2.8%
1/36 • Number of events 2 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Investigations
Liver function test abnormal
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Investigations
Lymphocyte count decreased
|
66.7%
2/3 • Number of events 4 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
50.0%
2/4 • Number of events 4 • From start of study drug administration up to 200 weeks
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 200 weeks
|
30.0%
3/10 • Number of events 8 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
5.7%
2/35 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
9.8%
4/41 • Number of events 22 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 1 • From start of study drug administration up to 200 weeks
|
2.8%
1/36 • Number of events 2 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 2 • From start of study drug administration up to 200 weeks
|
3.0%
1/33 • Number of events 1 • From start of study drug administration up to 200 weeks
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
25.0%
1/4 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.4%
1/41 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.0%
1/33 • Number of events 2 • From start of study drug administration up to 200 weeks
|
|
Investigations
Weight decreased
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
33.3%
2/6 • Number of events 3 • From start of study drug administration up to 200 weeks
|
20.0%
2/10 • Number of events 2 • From start of study drug administration up to 200 weeks
|
33.3%
1/3 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
28.6%
2/7 • Number of events 4 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
15.6%
5/32 • Number of events 6 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
2.9%
1/35 • Number of events 5 • From start of study drug administration up to 200 weeks
|
2.9%
2/68 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 8 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
10.0%
4/40 • Number of events 4 • From start of study drug administration up to 200 weeks
|
12.2%
5/41 • Number of events 9 • From start of study drug administration up to 200 weeks
|
12.0%
10/83 • Number of events 16 • From start of study drug administration up to 200 weeks
|
8.3%
3/36 • Number of events 5 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 2 • From start of study drug administration up to 200 weeks
|
3.0%
1/33 • Number of events 1 • From start of study drug administration up to 200 weeks
|
|
Investigations
Weight increased
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
33.3%
1/3 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
14.3%
1/7 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
13.3%
4/30 • Number of events 13 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
4.9%
2/41 • Number of events 4 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.0%
1/33 • Number of events 1 • From start of study drug administration up to 200 weeks
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
10.0%
1/10 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
66.7%
2/3 • Number of events 2 • From start of study drug administration up to 200 weeks
|
25.0%
1/4 • Number of events 1 • From start of study drug administration up to 200 weeks
|
16.7%
1/6 • Number of events 2 • From start of study drug administration up to 200 weeks
|
40.0%
4/10 • Number of events 4 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
14.3%
1/7 • Number of events 1 • From start of study drug administration up to 200 weeks
|
20.0%
3/15 • Number of events 3 • From start of study drug administration up to 200 weeks
|
31.2%
10/32 • Number of events 11 • From start of study drug administration up to 200 weeks
|
20.0%
6/30 • Number of events 7 • From start of study drug administration up to 200 weeks
|
17.1%
6/35 • Number of events 7 • From start of study drug administration up to 200 weeks
|
26.5%
18/68 • Number of events 20 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
18.4%
7/38 • Number of events 10 • From start of study drug administration up to 200 weeks
|
21.9%
7/32 • Number of events 8 • From start of study drug administration up to 200 weeks
|
22.5%
9/40 • Number of events 14 • From start of study drug administration up to 200 weeks
|
30.0%
12/40 • Number of events 16 • From start of study drug administration up to 200 weeks
|
29.3%
12/41 • Number of events 18 • From start of study drug administration up to 200 weeks
|
34.9%
29/83 • Number of events 51 • From start of study drug administration up to 200 weeks
|
27.8%
10/36 • Number of events 11 • From start of study drug administration up to 200 weeks
|
18.8%
6/32 • Number of events 7 • From start of study drug administration up to 200 weeks
|
24.2%
8/33 • Number of events 8 • From start of study drug administration up to 200 weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
14.3%
1/7 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
12.5%
4/32 • Number of events 4 • From start of study drug administration up to 200 weeks
|
20.0%
6/30 • Number of events 7 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
4.4%
3/68 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
10.5%
4/38 • Number of events 5 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
5.0%
2/40 • Number of events 2 • From start of study drug administration up to 200 weeks
|
2.4%
1/41 • Number of events 1 • From start of study drug administration up to 200 weeks
|
2.4%
2/83 • Number of events 2 • From start of study drug administration up to 200 weeks
|
5.6%
2/36 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
13.3%
2/15 • Number of events 2 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
5.3%
2/38 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 4 • From start of study drug administration up to 200 weeks
|
7.3%
3/41 • Number of events 4 • From start of study drug administration up to 200 weeks
|
9.6%
8/83 • Number of events 11 • From start of study drug administration up to 200 weeks
|
2.8%
1/36 • Number of events 1 • From start of study drug administration up to 200 weeks
|
9.4%
3/32 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
10.0%
1/10 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
33.3%
1/3 • Number of events 1 • From start of study drug administration up to 200 weeks
|
14.3%
1/7 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
12.5%
4/32 • Number of events 4 • From start of study drug administration up to 200 weeks
|
10.0%
3/30 • Number of events 5 • From start of study drug administration up to 200 weeks
|
8.6%
3/35 • Number of events 4 • From start of study drug administration up to 200 weeks
|
4.4%
3/68 • Number of events 3 • From start of study drug administration up to 200 weeks
|
33.3%
2/6 • Number of events 2 • From start of study drug administration up to 200 weeks
|
7.9%
3/38 • Number of events 3 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
12.2%
5/41 • Number of events 11 • From start of study drug administration up to 200 weeks
|
10.8%
9/83 • Number of events 12 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 5 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
10.0%
1/10 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
14.3%
1/7 • Number of events 3 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
6.7%
2/30 • Number of events 4 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
5.3%
2/38 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
12.0%
10/83 • Number of events 12 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
9.4%
3/32 • Number of events 3 • From start of study drug administration up to 200 weeks
|
6.1%
2/33 • Number of events 3 • From start of study drug administration up to 200 weeks
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
25.0%
1/4 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
2.9%
1/35 • Number of events 2 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.4%
1/41 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 200 weeks
|
20.0%
2/10 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
14.3%
1/7 • Number of events 1 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 1 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
6.7%
2/30 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
4.4%
3/68 • Number of events 4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
5.3%
2/38 • Number of events 2 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 2 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
4.9%
2/41 • Number of events 9 • From start of study drug administration up to 200 weeks
|
4.8%
4/83 • Number of events 4 • From start of study drug administration up to 200 weeks
|
5.6%
2/36 • Number of events 2 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
6.1%
2/33 • Number of events 2 • From start of study drug administration up to 200 weeks
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
33.3%
1/3 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
10.0%
1/10 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
14.3%
1/7 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 3 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
7.3%
3/41 • Number of events 7 • From start of study drug administration up to 200 weeks
|
2.4%
2/83 • Number of events 2 • From start of study drug administration up to 200 weeks
|
2.8%
1/36 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
6.1%
2/33 • Number of events 2 • From start of study drug administration up to 200 weeks
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
10.0%
1/10 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
5.3%
2/38 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
4.9%
2/41 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
16.7%
1/6 • Number of events 3 • From start of study drug administration up to 200 weeks
|
20.0%
2/10 • Number of events 3 • From start of study drug administration up to 200 weeks
|
66.7%
2/3 • Number of events 6 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
14.3%
1/7 • Number of events 3 • From start of study drug administration up to 200 weeks
|
20.0%
3/15 • Number of events 3 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 2 • From start of study drug administration up to 200 weeks
|
6.7%
2/30 • Number of events 5 • From start of study drug administration up to 200 weeks
|
17.1%
6/35 • Number of events 10 • From start of study drug administration up to 200 weeks
|
7.4%
5/68 • Number of events 5 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
7.9%
3/38 • Number of events 3 • From start of study drug administration up to 200 weeks
|
9.4%
3/32 • Number of events 3 • From start of study drug administration up to 200 weeks
|
10.0%
4/40 • Number of events 6 • From start of study drug administration up to 200 weeks
|
7.5%
3/40 • Number of events 3 • From start of study drug administration up to 200 weeks
|
9.8%
4/41 • Number of events 4 • From start of study drug administration up to 200 weeks
|
9.6%
8/83 • Number of events 10 • From start of study drug administration up to 200 weeks
|
11.1%
4/36 • Number of events 4 • From start of study drug administration up to 200 weeks
|
12.5%
4/32 • Number of events 5 • From start of study drug administration up to 200 weeks
|
12.1%
4/33 • Number of events 4 • From start of study drug administration up to 200 weeks
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 4 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
5.3%
2/38 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
5.0%
2/40 • Number of events 2 • From start of study drug administration up to 200 weeks
|
5.0%
2/40 • Number of events 2 • From start of study drug administration up to 200 weeks
|
7.3%
3/41 • Number of events 6 • From start of study drug administration up to 200 weeks
|
3.6%
3/83 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 6 • From start of study drug administration up to 200 weeks
|
3.0%
1/33 • Number of events 3 • From start of study drug administration up to 200 weeks
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
10.0%
1/10 • Number of events 5 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 1 • From start of study drug administration up to 200 weeks
|
18.8%
6/32 • Number of events 6 • From start of study drug administration up to 200 weeks
|
13.3%
4/30 • Number of events 6 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
5.9%
4/68 • Number of events 4 • From start of study drug administration up to 200 weeks
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
7.5%
3/40 • Number of events 4 • From start of study drug administration up to 200 weeks
|
9.8%
4/41 • Number of events 4 • From start of study drug administration up to 200 weeks
|
7.2%
6/83 • Number of events 9 • From start of study drug administration up to 200 weeks
|
2.8%
1/36 • Number of events 1 • From start of study drug administration up to 200 weeks
|
9.4%
3/32 • Number of events 6 • From start of study drug administration up to 200 weeks
|
3.0%
1/33 • Number of events 2 • From start of study drug administration up to 200 weeks
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
66.7%
2/3 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
20.0%
2/10 • Number of events 3 • From start of study drug administration up to 200 weeks
|
33.3%
1/3 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
28.6%
2/7 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
5.7%
2/35 • Number of events 2 • From start of study drug administration up to 200 weeks
|
4.4%
3/68 • Number of events 5 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
5.3%
2/38 • Number of events 3 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 2 • From start of study drug administration up to 200 weeks
|
5.0%
2/40 • Number of events 3 • From start of study drug administration up to 200 weeks
|
10.0%
4/40 • Number of events 10 • From start of study drug administration up to 200 weeks
|
7.3%
3/41 • Number of events 7 • From start of study drug administration up to 200 weeks
|
14.5%
12/83 • Number of events 25 • From start of study drug administration up to 200 weeks
|
2.8%
1/36 • Number of events 1 • From start of study drug administration up to 200 weeks
|
15.6%
5/32 • Number of events 11 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
2.9%
1/35 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
2.8%
1/36 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
13.3%
2/15 • Number of events 3 • From start of study drug administration up to 200 weeks
|
9.4%
3/32 • Number of events 4 • From start of study drug administration up to 200 weeks
|
6.7%
2/30 • Number of events 2 • From start of study drug administration up to 200 weeks
|
11.4%
4/35 • Number of events 10 • From start of study drug administration up to 200 weeks
|
5.9%
4/68 • Number of events 9 • From start of study drug administration up to 200 weeks
|
50.0%
3/6 • Number of events 3 • From start of study drug administration up to 200 weeks
|
7.9%
3/38 • Number of events 3 • From start of study drug administration up to 200 weeks
|
15.6%
5/32 • Number of events 5 • From start of study drug administration up to 200 weeks
|
7.5%
3/40 • Number of events 6 • From start of study drug administration up to 200 weeks
|
5.0%
2/40 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
10.8%
9/83 • Number of events 15 • From start of study drug administration up to 200 weeks
|
5.6%
2/36 • Number of events 2 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 2 • From start of study drug administration up to 200 weeks
|
6.1%
2/33 • Number of events 2 • From start of study drug administration up to 200 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
10.0%
1/10 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
2.9%
1/35 • Number of events 3 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
33.3%
1/3 • Number of events 1 • From start of study drug administration up to 200 weeks
|
25.0%
1/4 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
13.3%
2/15 • Number of events 5 • From start of study drug administration up to 200 weeks
|
25.0%
8/32 • Number of events 10 • From start of study drug administration up to 200 weeks
|
13.3%
4/30 • Number of events 4 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
4.4%
3/68 • Number of events 4 • From start of study drug administration up to 200 weeks
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 200 weeks
|
10.5%
4/38 • Number of events 5 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
15.0%
6/40 • Number of events 9 • From start of study drug administration up to 200 weeks
|
19.5%
8/41 • Number of events 8 • From start of study drug administration up to 200 weeks
|
8.4%
7/83 • Number of events 13 • From start of study drug administration up to 200 weeks
|
5.6%
2/36 • Number of events 3 • From start of study drug administration up to 200 weeks
|
9.4%
3/32 • Number of events 3 • From start of study drug administration up to 200 weeks
|
3.0%
1/33 • Number of events 1 • From start of study drug administration up to 200 weeks
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
5.7%
2/35 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
14.3%
1/7 • Number of events 1 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 2 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
5.3%
2/38 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.4%
1/41 • Number of events 1 • From start of study drug administration up to 200 weeks
|
2.4%
2/83 • Number of events 3 • From start of study drug administration up to 200 weeks
|
2.8%
1/36 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
33.3%
1/3 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
5.7%
2/35 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
7.9%
3/38 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
5.0%
2/40 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 2 • From start of study drug administration up to 200 weeks
|
6.1%
2/33 • Number of events 2 • From start of study drug administration up to 200 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
25.0%
1/4 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 4 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 2 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
11.4%
4/35 • Number of events 5 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
5.3%
2/38 • Number of events 4 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.4%
1/41 • Number of events 1 • From start of study drug administration up to 200 weeks
|
3.6%
3/83 • Number of events 3 • From start of study drug administration up to 200 weeks
|
2.8%
1/36 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
6.1%
2/33 • Number of events 2 • From start of study drug administration up to 200 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
6.7%
2/30 • Number of events 3 • From start of study drug administration up to 200 weeks
|
2.9%
1/35 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
13.2%
5/38 • Number of events 5 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 4 • From start of study drug administration up to 200 weeks
|
10.0%
4/40 • Number of events 4 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
3.0%
1/33 • Number of events 1 • From start of study drug administration up to 200 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
7.9%
3/38 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
25.0%
1/4 • Number of events 5 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 1 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
5.7%
2/35 • Number of events 7 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 2 • From start of study drug administration up to 200 weeks
|
33.3%
2/6 • Number of events 2 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
7.5%
3/40 • Number of events 3 • From start of study drug administration up to 200 weeks
|
5.0%
2/40 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
8.4%
7/83 • Number of events 8 • From start of study drug administration up to 200 weeks
|
5.6%
2/36 • Number of events 3 • From start of study drug administration up to 200 weeks
|
9.4%
3/32 • Number of events 4 • From start of study drug administration up to 200 weeks
|
3.0%
1/33 • Number of events 2 • From start of study drug administration up to 200 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 1 • From start of study drug administration up to 200 weeks
|
18.8%
6/32 • Number of events 7 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 2 • From start of study drug administration up to 200 weeks
|
5.7%
2/35 • Number of events 2 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
10.5%
4/38 • Number of events 4 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
4.9%
2/41 • Number of events 2 • From start of study drug administration up to 200 weeks
|
6.0%
5/83 • Number of events 5 • From start of study drug administration up to 200 weeks
|
5.6%
2/36 • Number of events 2 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 2 • From start of study drug administration up to 200 weeks
|
6.1%
2/33 • Number of events 2 • From start of study drug administration up to 200 weeks
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
2.9%
2/68 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
9.4%
3/32 • Number of events 4 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
4.9%
2/41 • Number of events 2 • From start of study drug administration up to 200 weeks
|
2.4%
2/83 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
9.4%
3/32 • Number of events 4 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
20.0%
2/10 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
13.3%
2/15 • Number of events 2 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 2 • From start of study drug administration up to 200 weeks
|
10.0%
3/30 • Number of events 3 • From start of study drug administration up to 200 weeks
|
2.9%
1/35 • Number of events 2 • From start of study drug administration up to 200 weeks
|
5.9%
4/68 • Number of events 4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
5.3%
2/38 • Number of events 2 • From start of study drug administration up to 200 weeks
|
9.4%
3/32 • Number of events 3 • From start of study drug administration up to 200 weeks
|
7.5%
3/40 • Number of events 4 • From start of study drug administration up to 200 weeks
|
5.0%
2/40 • Number of events 5 • From start of study drug administration up to 200 weeks
|
4.9%
2/41 • Number of events 3 • From start of study drug administration up to 200 weeks
|
3.6%
3/83 • Number of events 3 • From start of study drug administration up to 200 weeks
|
5.6%
2/36 • Number of events 4 • From start of study drug administration up to 200 weeks
|
9.4%
3/32 • Number of events 4 • From start of study drug administration up to 200 weeks
|
15.2%
5/33 • Number of events 5 • From start of study drug administration up to 200 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 2 • From start of study drug administration up to 200 weeks
|
2.4%
1/41 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 1 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 2 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
2.4%
1/41 • Number of events 1 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 1 • From start of study drug administration up to 200 weeks
|
2.8%
1/36 • Number of events 3 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hair follicle tumour benign
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Juvenile melanoma benign
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Keratoacanthoma
|
33.3%
1/3 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
25.0%
1/4 • Number of events 1 • From start of study drug administration up to 200 weeks
|
16.7%
1/6 • Number of events 2 • From start of study drug administration up to 200 weeks
|
10.0%
1/10 • Number of events 1 • From start of study drug administration up to 200 weeks
|
33.3%
1/3 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
28.6%
2/7 • Number of events 2 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 1 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
6.7%
2/30 • Number of events 3 • From start of study drug administration up to 200 weeks
|
5.7%
2/35 • Number of events 2 • From start of study drug administration up to 200 weeks
|
8.8%
6/68 • Number of events 8 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
5.3%
2/38 • Number of events 3 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 2 • From start of study drug administration up to 200 weeks
|
7.5%
3/40 • Number of events 3 • From start of study drug administration up to 200 weeks
|
7.5%
3/40 • Number of events 3 • From start of study drug administration up to 200 weeks
|
14.6%
6/41 • Number of events 6 • From start of study drug administration up to 200 weeks
|
2.4%
2/83 • Number of events 2 • From start of study drug administration up to 200 weeks
|
5.6%
2/36 • Number of events 2 • From start of study drug administration up to 200 weeks
|
9.4%
3/32 • Number of events 4 • From start of study drug administration up to 200 weeks
|
6.1%
2/33 • Number of events 3 • From start of study drug administration up to 200 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.4%
1/41 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
5.0%
2/40 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
33.3%
1/3 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 2 • From start of study drug administration up to 200 weeks
|
5.7%
2/35 • Number of events 2 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
5.0%
2/40 • Number of events 3 • From start of study drug administration up to 200 weeks
|
5.0%
2/40 • Number of events 4 • From start of study drug administration up to 200 weeks
|
2.4%
1/41 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 1 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 2 • From start of study drug administration up to 200 weeks
|
5.0%
2/40 • Number of events 2 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Nervous system disorders
Amnesia
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
5.7%
2/35 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Nervous system disorders
Ataxia
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
5.7%
2/35 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
10.0%
1/10 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
14.3%
1/7 • Number of events 1 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 3 • From start of study drug administration up to 200 weeks
|
9.4%
3/32 • Number of events 3 • From start of study drug administration up to 200 weeks
|
10.0%
3/30 • Number of events 7 • From start of study drug administration up to 200 weeks
|
5.7%
2/35 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 3 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
10.0%
4/40 • Number of events 5 • From start of study drug administration up to 200 weeks
|
12.2%
5/41 • Number of events 5 • From start of study drug administration up to 200 weeks
|
6.0%
5/83 • Number of events 6 • From start of study drug administration up to 200 weeks
|
13.9%
5/36 • Number of events 5 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.0%
1/33 • Number of events 1 • From start of study drug administration up to 200 weeks
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
5.3%
2/38 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
25.0%
1/4 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.0%
1/33 • Number of events 1 • From start of study drug administration up to 200 weeks
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
33.3%
1/3 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
3.6%
3/83 • Number of events 6 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
5.3%
2/38 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.0%
1/33 • Number of events 1 • From start of study drug administration up to 200 weeks
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
14.3%
1/7 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.4%
1/41 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
25.0%
1/4 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
20.0%
2/10 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
26.7%
4/15 • Number of events 5 • From start of study drug administration up to 200 weeks
|
9.4%
3/32 • Number of events 8 • From start of study drug administration up to 200 weeks
|
6.7%
2/30 • Number of events 2 • From start of study drug administration up to 200 weeks
|
34.3%
12/35 • Number of events 15 • From start of study drug administration up to 200 weeks
|
5.9%
4/68 • Number of events 6 • From start of study drug administration up to 200 weeks
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 200 weeks
|
18.4%
7/38 • Number of events 11 • From start of study drug administration up to 200 weeks
|
18.8%
6/32 • Number of events 6 • From start of study drug administration up to 200 weeks
|
7.5%
3/40 • Number of events 3 • From start of study drug administration up to 200 weeks
|
10.0%
4/40 • Number of events 7 • From start of study drug administration up to 200 weeks
|
12.2%
5/41 • Number of events 5 • From start of study drug administration up to 200 weeks
|
12.0%
10/83 • Number of events 12 • From start of study drug administration up to 200 weeks
|
8.3%
3/36 • Number of events 3 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 2 • From start of study drug administration up to 200 weeks
|
21.2%
7/33 • Number of events 8 • From start of study drug administration up to 200 weeks
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
5.3%
2/38 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Nervous system disorders
Lethargy
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
33.3%
1/3 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
2.9%
1/35 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
5.7%
2/35 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.4%
1/41 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
33.3%
1/3 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
20.0%
3/15 • Number of events 3 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
5.7%
2/35 • Number of events 2 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.4%
1/41 • Number of events 1 • From start of study drug administration up to 200 weeks
|
2.4%
2/83 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 2 • From start of study drug administration up to 200 weeks
|
3.0%
1/33 • Number of events 1 • From start of study drug administration up to 200 weeks
|
|
Nervous system disorders
Peripheral motor neuropathy
|
33.3%
1/3 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
10.0%
1/10 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 1 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 2 • From start of study drug administration up to 200 weeks
|
2.9%
1/35 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
4.9%
2/41 • Number of events 3 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 3 • From start of study drug administration up to 200 weeks
|
2.8%
1/36 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Nervous system disorders
Presyncope
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
2.9%
1/35 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.4%
1/41 • Number of events 1 • From start of study drug administration up to 200 weeks
|
2.4%
2/83 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
5.7%
2/35 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.4%
1/41 • Number of events 1 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 1 • From start of study drug administration up to 200 weeks
|
2.8%
1/36 • Number of events 1 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 200 weeks
|
5.3%
2/38 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Nervous system disorders
Tremor
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
10.0%
1/10 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
2.9%
1/35 • Number of events 1 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
7.3%
3/41 • Number of events 3 • From start of study drug administration up to 200 weeks
|
2.4%
2/83 • Number of events 2 • From start of study drug administration up to 200 weeks
|
2.8%
1/36 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
33.3%
1/3 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
14.3%
1/7 • Number of events 4 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 3 • From start of study drug administration up to 200 weeks
|
12.5%
4/32 • Number of events 5 • From start of study drug administration up to 200 weeks
|
6.7%
2/30 • Number of events 2 • From start of study drug administration up to 200 weeks
|
2.9%
1/35 • Number of events 1 • From start of study drug administration up to 200 weeks
|
4.4%
3/68 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
10.5%
4/38 • Number of events 5 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
7.3%
3/41 • Number of events 3 • From start of study drug administration up to 200 weeks
|
6.0%
5/83 • Number of events 5 • From start of study drug administration up to 200 weeks
|
2.8%
1/36 • Number of events 2 • From start of study drug administration up to 200 weeks
|
9.4%
3/32 • Number of events 3 • From start of study drug administration up to 200 weeks
|
15.2%
5/33 • Number of events 5 • From start of study drug administration up to 200 weeks
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
10.0%
1/10 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
8.6%
3/35 • Number of events 4 • From start of study drug administration up to 200 weeks
|
2.9%
2/68 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
7.9%
3/38 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
5.6%
2/36 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 1 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
8.6%
3/35 • Number of events 3 • From start of study drug administration up to 200 weeks
|
5.9%
4/68 • Number of events 4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
5.0%
2/40 • Number of events 2 • From start of study drug administration up to 200 weeks
|
2.4%
1/41 • Number of events 1 • From start of study drug administration up to 200 weeks
|
4.8%
4/83 • Number of events 4 • From start of study drug administration up to 200 weeks
|
5.6%
2/36 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.0%
1/33 • Number of events 1 • From start of study drug administration up to 200 weeks
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
25.0%
1/4 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
33.3%
1/3 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
13.3%
2/15 • Number of events 3 • From start of study drug administration up to 200 weeks
|
15.6%
5/32 • Number of events 5 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
11.4%
4/35 • Number of events 4 • From start of study drug administration up to 200 weeks
|
7.4%
5/68 • Number of events 6 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
10.5%
4/38 • Number of events 14 • From start of study drug administration up to 200 weeks
|
12.5%
4/32 • Number of events 4 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
12.5%
5/40 • Number of events 6 • From start of study drug administration up to 200 weeks
|
9.8%
4/41 • Number of events 4 • From start of study drug administration up to 200 weeks
|
7.2%
6/83 • Number of events 6 • From start of study drug administration up to 200 weeks
|
5.6%
2/36 • Number of events 2 • From start of study drug administration up to 200 weeks
|
9.4%
3/32 • Number of events 3 • From start of study drug administration up to 200 weeks
|
6.1%
2/33 • Number of events 2 • From start of study drug administration up to 200 weeks
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
14.3%
1/7 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 2 • From start of study drug administration up to 200 weeks
|
2.9%
1/35 • Number of events 1 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 2 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 5 • From start of study drug administration up to 200 weeks
|
2.8%
1/36 • Number of events 1 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Renal and urinary disorders
Bladder spasm
|
33.3%
1/3 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 1 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 1 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
2.8%
1/36 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
14.3%
1/7 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 2 • From start of study drug administration up to 200 weeks
|
9.4%
3/32 • Number of events 3 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.0%
1/33 • Number of events 1 • From start of study drug administration up to 200 weeks
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
33.3%
1/3 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
26.7%
4/15 • Number of events 5 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
2.9%
1/35 • Number of events 2 • From start of study drug administration up to 200 weeks
|
2.9%
2/68 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
2.4%
1/41 • Number of events 1 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 4 • From start of study drug administration up to 200 weeks
|
5.6%
2/36 • Number of events 2 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
10.0%
1/10 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
2.9%
1/35 • Number of events 1 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.4%
1/41 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
20.0%
2/10 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
33.3%
1/3 • Number of events 1 • From start of study drug administration up to 200 weeks
|
28.6%
2/7 • Number of events 5 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.4%
1/41 • Number of events 1 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
5.3%
2/38 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Renal and urinary disorders
Renal vein thrombosis
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
6.7%
2/30 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
8.6%
3/35 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
4.9%
2/41 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 1 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
6.1%
2/33 • Number of events 3 • From start of study drug administration up to 200 weeks
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
5.3%
2/38 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 1 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
33.3%
1/3 • Number of events 1 • From start of study drug administration up to 200 weeks
|
33.3%
1/3 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
10.0%
1/10 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
14.3%
1/7 • Number of events 2 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 4 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 1 • From start of study drug administration up to 200 weeks
|
2.8%
1/36 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
7.3%
3/41 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
25.0%
1/4 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
20.0%
2/10 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
13.3%
2/15 • Number of events 3 • From start of study drug administration up to 200 weeks
|
18.8%
6/32 • Number of events 6 • From start of study drug administration up to 200 weeks
|
10.0%
3/30 • Number of events 5 • From start of study drug administration up to 200 weeks
|
2.9%
1/35 • Number of events 2 • From start of study drug administration up to 200 weeks
|
10.3%
7/68 • Number of events 7 • From start of study drug administration up to 200 weeks
|
16.7%
1/6 • Number of events 4 • From start of study drug administration up to 200 weeks
|
13.2%
5/38 • Number of events 9 • From start of study drug administration up to 200 weeks
|
9.4%
3/32 • Number of events 3 • From start of study drug administration up to 200 weeks
|
7.5%
3/40 • Number of events 4 • From start of study drug administration up to 200 weeks
|
22.5%
9/40 • Number of events 9 • From start of study drug administration up to 200 weeks
|
14.6%
6/41 • Number of events 6 • From start of study drug administration up to 200 weeks
|
28.9%
24/83 • Number of events 36 • From start of study drug administration up to 200 weeks
|
5.6%
2/36 • Number of events 3 • From start of study drug administration up to 200 weeks
|
15.6%
5/32 • Number of events 7 • From start of study drug administration up to 200 weeks
|
15.2%
5/33 • Number of events 7 • From start of study drug administration up to 200 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
10.0%
1/10 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
2.4%
1/41 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
25.0%
1/4 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
30.0%
3/10 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
14.3%
1/7 • Number of events 1 • From start of study drug administration up to 200 weeks
|
26.7%
4/15 • Number of events 6 • From start of study drug administration up to 200 weeks
|
28.1%
9/32 • Number of events 14 • From start of study drug administration up to 200 weeks
|
33.3%
10/30 • Number of events 12 • From start of study drug administration up to 200 weeks
|
5.7%
2/35 • Number of events 2 • From start of study drug administration up to 200 weeks
|
16.2%
11/68 • Number of events 16 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
21.1%
8/38 • Number of events 8 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 3 • From start of study drug administration up to 200 weeks
|
22.5%
9/40 • Number of events 9 • From start of study drug administration up to 200 weeks
|
22.5%
9/40 • Number of events 13 • From start of study drug administration up to 200 weeks
|
31.7%
13/41 • Number of events 17 • From start of study drug administration up to 200 weeks
|
27.7%
23/83 • Number of events 32 • From start of study drug administration up to 200 weeks
|
8.3%
3/36 • Number of events 5 • From start of study drug administration up to 200 weeks
|
18.8%
6/32 • Number of events 8 • From start of study drug administration up to 200 weeks
|
24.2%
8/33 • Number of events 9 • From start of study drug administration up to 200 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 1 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
4.4%
3/68 • Number of events 4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
50.0%
2/4 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
20.0%
2/10 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
40.0%
6/15 • Number of events 6 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 2 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
20.6%
14/68 • Number of events 15 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
26.3%
10/38 • Number of events 12 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 3 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
7.5%
3/40 • Number of events 5 • From start of study drug administration up to 200 weeks
|
9.8%
4/41 • Number of events 5 • From start of study drug administration up to 200 weeks
|
15.7%
13/83 • Number of events 14 • From start of study drug administration up to 200 weeks
|
5.6%
2/36 • Number of events 2 • From start of study drug administration up to 200 weeks
|
21.9%
7/32 • Number of events 8 • From start of study drug administration up to 200 weeks
|
12.1%
4/33 • Number of events 4 • From start of study drug administration up to 200 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 4 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
7.9%
3/38 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
10.0%
4/40 • Number of events 5 • From start of study drug administration up to 200 weeks
|
10.0%
4/40 • Number of events 6 • From start of study drug administration up to 200 weeks
|
7.3%
3/41 • Number of events 3 • From start of study drug administration up to 200 weeks
|
16.9%
14/83 • Number of events 16 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
12.5%
4/32 • Number of events 4 • From start of study drug administration up to 200 weeks
|
3.0%
1/33 • Number of events 1 • From start of study drug administration up to 200 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal haemorrhage
|
33.3%
1/3 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.4%
1/41 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
33.3%
1/3 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
10.0%
1/10 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 1 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 3 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
5.3%
2/38 • Number of events 4 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
5.0%
2/40 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
5.6%
2/36 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
14.3%
1/7 • Number of events 1 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
6.7%
2/30 • Number of events 3 • From start of study drug administration up to 200 weeks
|
2.9%
1/35 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.4%
1/41 • Number of events 1 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 1 • From start of study drug administration up to 200 weeks
|
2.8%
1/36 • Number of events 1 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
6.1%
2/33 • Number of events 2 • From start of study drug administration up to 200 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
10.0%
1/10 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
15.6%
5/32 • Number of events 6 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
2.9%
2/68 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
14.6%
6/41 • Number of events 9 • From start of study drug administration up to 200 weeks
|
2.4%
2/83 • Number of events 2 • From start of study drug administration up to 200 weeks
|
2.8%
1/36 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
12.1%
4/33 • Number of events 5 • From start of study drug administration up to 200 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
25.0%
1/4 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
7.5%
3/40 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
13.3%
2/15 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
5.3%
2/38 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
5.0%
2/40 • Number of events 5 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
2.8%
1/36 • Number of events 1 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
3.0%
1/33 • Number of events 1 • From start of study drug administration up to 200 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
6.7%
2/30 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
4.9%
2/41 • Number of events 2 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 2 • From start of study drug administration up to 200 weeks
|
3.0%
1/33 • Number of events 2 • From start of study drug administration up to 200 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
6.7%
2/30 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
5.3%
2/38 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
10.0%
4/40 • Number of events 4 • From start of study drug administration up to 200 weeks
|
7.5%
3/40 • Number of events 4 • From start of study drug administration up to 200 weeks
|
4.9%
2/41 • Number of events 2 • From start of study drug administration up to 200 weeks
|
7.2%
6/83 • Number of events 8 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
9.4%
3/32 • Number of events 3 • From start of study drug administration up to 200 weeks
|
6.1%
2/33 • Number of events 3 • From start of study drug administration up to 200 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 1 • From start of study drug administration up to 200 weeks
|
11.1%
4/36 • Number of events 4 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.0%
1/33 • Number of events 1 • From start of study drug administration up to 200 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
25.0%
1/4 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
33.3%
1/3 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.4%
1/41 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
5.3%
2/38 • Number of events 4 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
2.9%
1/35 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
5.3%
2/38 • Number of events 2 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 2 • From start of study drug administration up to 200 weeks
|
3.0%
1/33 • Number of events 1 • From start of study drug administration up to 200 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
6.1%
2/33 • Number of events 2 • From start of study drug administration up to 200 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
9.4%
3/32 • Number of events 3 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
2.4%
2/83 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 4 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.4%
1/41 • Number of events 1 • From start of study drug administration up to 200 weeks
|
3.6%
3/83 • Number of events 3 • From start of study drug administration up to 200 weeks
|
2.8%
1/36 • Number of events 1 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 6 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
2.9%
2/68 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
50.0%
2/4 • Number of events 4 • From start of study drug administration up to 200 weeks
|
33.3%
2/6 • Number of events 3 • From start of study drug administration up to 200 weeks
|
20.0%
2/10 • Number of events 8 • From start of study drug administration up to 200 weeks
|
66.7%
2/3 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
42.9%
3/7 • Number of events 5 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 13 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
2.9%
1/35 • Number of events 1 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
5.0%
2/40 • Number of events 8 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
14.6%
6/41 • Number of events 7 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 4 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
9.4%
3/32 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
25.0%
1/4 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
10.0%
1/10 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
33.3%
1/3 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis psoriasiform
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 5 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
33.3%
1/3 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
10.0%
1/10 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
28.6%
2/7 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
2.9%
1/35 • Number of events 1 • From start of study drug administration up to 200 weeks
|
7.4%
5/68 • Number of events 5 • From start of study drug administration up to 200 weeks
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 200 weeks
|
7.9%
3/38 • Number of events 4 • From start of study drug administration up to 200 weeks
|
9.4%
3/32 • Number of events 3 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
7.5%
3/40 • Number of events 7 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
7.2%
6/83 • Number of events 12 • From start of study drug administration up to 200 weeks
|
2.8%
1/36 • Number of events 1 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
9.1%
3/33 • Number of events 3 • From start of study drug administration up to 200 weeks
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
5.7%
2/35 • Number of events 4 • From start of study drug administration up to 200 weeks
|
2.9%
2/68 • Number of events 5 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 2 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 3 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 9 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
4.8%
4/83 • Number of events 6 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 2 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
1.5%
1/68 • Number of events 5 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
5.3%
2/38 • Number of events 4 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
2.5%
1/40 • Number of events 1 • From start of study drug administration up to 200 weeks
|
7.5%
3/40 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
3.6%
3/83 • Number of events 4 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 6 • From start of study drug administration up to 200 weeks
|
6.1%
2/33 • Number of events 2 • From start of study drug administration up to 200 weeks
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 1 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 200 weeks
|
5.3%
2/38 • Number of events 2 • From start of study drug administration up to 200 weeks
|
9.4%
3/32 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.4%
1/41 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.0%
1/33 • Number of events 1 • From start of study drug administration up to 200 weeks
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 2 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
2.9%
2/68 • Number of events 6 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
5.0%
2/40 • Number of events 5 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
2.4%
1/41 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
2.8%
1/36 • Number of events 1 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 4 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Skin and subcutaneous tissue disorders
Hypertrichosis
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Skin and subcutaneous tissue disorders
Neurodermatitis
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
6.7%
1/15 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
3.3%
1/30 • Number of events 1 • From start of study drug administration up to 200 weeks
|
2.9%
1/35 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/38 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
1.2%
1/83 • Number of events 1 • From start of study drug administration up to 200 weeks
|
2.8%
1/36 • Number of events 1 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
1/3 • Number of events 3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
50.0%
2/4 • Number of events 4 • From start of study drug administration up to 200 weeks
|
33.3%
2/6 • Number of events 6 • From start of study drug administration up to 200 weeks
|
10.0%
1/10 • Number of events 5 • From start of study drug administration up to 200 weeks
|
66.7%
2/3 • Number of events 2 • From start of study drug administration up to 200 weeks
|
33.3%
1/3 • Number of events 4 • From start of study drug administration up to 200 weeks
|
28.6%
2/7 • Number of events 3 • From start of study drug administration up to 200 weeks
|
33.3%
5/15 • Number of events 14 • From start of study drug administration up to 200 weeks
|
9.4%
3/32 • Number of events 3 • From start of study drug administration up to 200 weeks
|
16.7%
5/30 • Number of events 9 • From start of study drug administration up to 200 weeks
|
20.0%
7/35 • Number of events 22 • From start of study drug administration up to 200 weeks
|
29.4%
20/68 • Number of events 40 • From start of study drug administration up to 200 weeks
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 200 weeks
|
39.5%
15/38 • Number of events 34 • From start of study drug administration up to 200 weeks
|
37.5%
12/32 • Number of events 17 • From start of study drug administration up to 200 weeks
|
30.0%
12/40 • Number of events 20 • From start of study drug administration up to 200 weeks
|
15.0%
6/40 • Number of events 11 • From start of study drug administration up to 200 weeks
|
17.1%
7/41 • Number of events 7 • From start of study drug administration up to 200 weeks
|
27.7%
23/83 • Number of events 36 • From start of study drug administration up to 200 weeks
|
11.1%
4/36 • Number of events 5 • From start of study drug administration up to 200 weeks
|
21.9%
7/32 • Number of events 8 • From start of study drug administration up to 200 weeks
|
12.1%
4/33 • Number of events 6 • From start of study drug administration up to 200 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
13.3%
2/15 • Number of events 2 • From start of study drug administration up to 200 weeks
|
12.5%
4/32 • Number of events 5 • From start of study drug administration up to 200 weeks
|
13.3%
4/30 • Number of events 11 • From start of study drug administration up to 200 weeks
|
17.1%
6/35 • Number of events 8 • From start of study drug administration up to 200 weeks
|
5.9%
4/68 • Number of events 13 • From start of study drug administration up to 200 weeks
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 200 weeks
|
21.1%
8/38 • Number of events 10 • From start of study drug administration up to 200 weeks
|
3.1%
1/32 • Number of events 1 • From start of study drug administration up to 200 weeks
|
15.0%
6/40 • Number of events 14 • From start of study drug administration up to 200 weeks
|
7.5%
3/40 • Number of events 5 • From start of study drug administration up to 200 weeks
|
7.3%
3/41 • Number of events 5 • From start of study drug administration up to 200 weeks
|
4.8%
4/83 • Number of events 6 • From start of study drug administration up to 200 weeks
|
5.6%
2/36 • Number of events 2 • From start of study drug administration up to 200 weeks
|
6.2%
2/32 • Number of events 2 • From start of study drug administration up to 200 weeks
|
12.1%
4/33 • Number of events 4 • From start of study drug administration up to 200 weeks
|
|
Skin and subcutaneous tissue disorders
Rash follicular
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/4 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
0.00%
0/10 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/3 • From start of study drug administration up to 200 weeks
|
0.00%
0/7 • From start of study drug administration up to 200 weeks
|
0.00%
0/15 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/30 • From start of study drug administration up to 200 weeks
|
0.00%
0/35 • From start of study drug administration up to 200 weeks
|
0.00%
0/68 • From start of study drug administration up to 200 weeks
|
0.00%
0/6 • From start of study drug administration up to 200 weeks
|
5.3%
2/38 • Number of events 8 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/40 • From start of study drug administration up to 200 weeks
|
0.00%
0/41 • From start of study drug administration up to 200 weeks
|
0.00%
0/83 • From start of study drug administration up to 200 weeks
|
0.00%
0/36 • From start of study drug administration up to 200 weeks
|
0.00%
0/32 • From start of study drug administration up to 200 weeks
|
0.00%
0/33 • From start of study drug administration up to 200 weeks
|
Additional Information
Communication Center
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Phone: +49 6151-72-5200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place