Trial Outcomes & Findings for Avelumab in Metastatic or Locally Advanced Solid Tumors (JAVELIN Solid Tumor) (NCT NCT01772004)
NCT ID: NCT01772004
Last Updated: 2021-12-20
Results Overview
DLT: defined using National Cancer Institute Common Toxicity Criteria for Adverse Events Version 4.0, as any one of following: any Grade (Gr) \>=3toxicity that is possibly/probably/ definitely related to avelumab, except for any of following: Gr 3 infusion-related reaction resolving within 6 hours and controlled with medical management, Transient Gr 3 flu-like symptoms/fever, which is controlled with medical management, Transient Gr 3 fatigue, local reactions, headache, nausea, emesis that resolves to \<= Gr 1, Gr3 diarrhea, Gr 3 skin toxicity, Gr 3 liver function test increase that resolves to \<= Gr1 in \< 7 days after medical management has been initiated, Single laboratory values out of normal range that were unlikely related to study treatment according to investigator, did not have any clinical correlate, and resolved to \<= Gr1 within 7 days with adequate medical management and tumor flare phenomenon defined as local pain, irritation/rash localized at sites of known/suspected tumor.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
1756 participants
Primary outcome timeframe
Dose Escalation: Baseline up to Week 3
Results posted on
2021-12-20
Participant Flow
First participant signed informed consent: 31 January 2013, Last Participant Last Visit: 16 December 2019.
Participant milestones
| Measure |
Dose Escalation Cohort: Avelumab 1.0 mg/kg
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 1.0 milligrams per kilogram (mg/kg) once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or investigational medicinal product (IMP) occurs.
|
Dose Escalation Cohort: Avelumab 3.0 mg/kg
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 3.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 10.0 mg/kg
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 20.0 mg/kg
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 20.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 10.0 mg/kg Weekly
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once weekly for the first 12 weeks and once every 2 weeks starting Week 13 in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: NSCLC, Post-platinum Doublet
Participants with non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: NSCLC, First Line
Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: Metastatic Breast Cancer
Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: GC/GEJC Progressed
Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: GC/GEJC Non Progressed
Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Colorectal Cancer
Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Castrate-resistant Prostate Cancer
Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Adrenocortical Carcinoma
Participants with adrenocortical carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Melanoma
Participants with melanoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Mesothelioma
Participants with mesothelioma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Urothelial Carcinoma
Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Ovarian Cancer
Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)
Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)
Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: Ovarian Cancer
Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: Urothelial Carcinoma
Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: GC/GEJC, Third Line
Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: HNSCC
Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation Phase
STARTED
|
4
|
13
|
15
|
21
|
8
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Escalation Phase
COMPLETED
|
4
|
13
|
15
|
21
|
8
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Escalation Phase
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Expansion Phase
STARTED
|
0
|
0
|
0
|
0
|
0
|
184
|
156
|
168
|
60
|
90
|
21
|
18
|
50
|
51
|
53
|
44
|
125
|
62
|
20
|
103
|
205
|
132
|
153
|
|
Dose Expansion Phase
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
184
|
156
|
168
|
60
|
90
|
21
|
18
|
50
|
51
|
53
|
44
|
125
|
62
|
20
|
103
|
205
|
132
|
153
|
|
Dose Expansion Phase
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Avelumab in Metastatic or Locally Advanced Solid Tumors (JAVELIN Solid Tumor)
Baseline characteristics by cohort
| Measure |
Dose Escalation Cohort: Avelumab 1.0 mg/kg
n=4 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 1.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 3.0 mg/kg
n=13 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 3.0 milligrams per kilogram (mg/kg) once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or investigational medicinal product (IMP) occurs.
|
Dose Escalation Cohort: Avelumab 10.0 mg/kg
n=15 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 20.0 mg/kg
n=21 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 20.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 10.0 mg/kg Weekly
n=8 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once weekly for the first 12 weeks and once every 2 weeks starting Week 13 in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: NSCLC, Post-platinum Doublet
n=184 Participants
Participants with non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: NSCLC, First Line
n=156 Participants
Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: Metastatic Breast Cancer
n=168 Participants
Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: GC/GEJC Progressed
n=60 Participants
Participants with gastric and gastroesophageal cancer who progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: GC/GEJC Non Progressed
n=90 Participants
Participants with gastric and gastroesophageal cancer who non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Colorectal Cancer
n=21 Participants
Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Castrate-resistant Prostate Cancer
n=18 Participants
Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Adrenocortical Carcinoma
n=50 Participants
Participants with adrenocortical carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Melanoma
n=51 Participants
Participants with melanoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Mesothelioma
n=53 Participants
Participants with mesothelioma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Urothelial Carcinoma
n=44 Participants
Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Ovarian Cancer
n=125 Participants
Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)
n=62 Participants
Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)
n=20 Participants
Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: Ovarian Cancer
n=103 Participants
Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: Urothelial Carcinoma
n=205 Participants
Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: GC/GEJC, Third Line
n=132 Participants
Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: HNSCC
n=153 Participants
Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Total
n=1756 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=138 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
100 Participants
n=30 Participants
|
83 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
46 Participants
n=114 Participants
|
68 Participants
|
14 Participants
n=19 Participants
|
18 Participants
n=4 Participants
|
24 Participants
n=7 Participants
|
34 Participants
n=7 Participants
|
32 Participants
n=3 Participants
|
30 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
43 Participants
n=102 Participants
|
15 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
148 Participants
n=15 Participants
|
85 Participants
n=138 Participants
|
125 Participants
n=4 Participants
|
895 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
18 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
90 Participants
n=30 Participants
|
51 Participants
n=3 Participants
|
140 Participants
n=6 Participants
|
38 Participants
n=114 Participants
|
61 Participants
|
19 Participants
n=19 Participants
|
7 Participants
n=4 Participants
|
46 Participants
n=7 Participants
|
28 Participants
n=7 Participants
|
20 Participants
n=3 Participants
|
11 Participants
n=4 Participants
|
74 Participants
n=2 Participants
|
37 Participants
n=102 Participants
|
7 Participants
n=5 Participants
|
52 Participants
n=5 Participants
|
66 Participants
n=15 Participants
|
91 Participants
n=138 Participants
|
97 Participants
n=4 Participants
|
980 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
94 Participants
n=30 Participants
|
105 Participants
n=3 Participants
|
28 Participants
n=6 Participants
|
22 Participants
n=114 Participants
|
29 Participants
|
2 Participants
n=19 Participants
|
11 Participants
n=4 Participants
|
4 Participants
n=7 Participants
|
23 Participants
n=7 Participants
|
33 Participants
n=3 Participants
|
33 Participants
n=4 Participants
|
51 Participants
n=2 Participants
|
25 Participants
n=102 Participants
|
13 Participants
n=5 Participants
|
51 Participants
n=5 Participants
|
139 Participants
n=15 Participants
|
41 Participants
n=138 Participants
|
56 Participants
n=4 Participants
|
776 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
84 Participants
n=30 Participants
|
73 Participants
n=3 Participants
|
167 Participants
n=6 Participants
|
14 Participants
n=114 Participants
|
22 Participants
|
7 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
26 Participants
n=7 Participants
|
17 Participants
n=7 Participants
|
21 Participants
n=3 Participants
|
14 Participants
n=4 Participants
|
125 Participants
n=2 Participants
|
19 Participants
n=102 Participants
|
5 Participants
n=5 Participants
|
103 Participants
n=5 Participants
|
57 Participants
n=15 Participants
|
47 Participants
n=138 Participants
|
28 Participants
n=4 Participants
|
861 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=2 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=15 Participants
|
2 Participants
n=138 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
5 Participants
n=30 Participants
|
6 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
13 Participants
n=114 Participants
|
35 Participants
|
1 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=2 Participants
|
6 Participants
n=102 Participants
|
0 Participants
n=5 Participants
|
7 Participants
n=5 Participants
|
15 Participants
n=15 Participants
|
42 Participants
n=138 Participants
|
19 Participants
n=4 Participants
|
163 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=15 Participants
|
0 Participants
n=138 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
12 Participants
n=30 Participants
|
12 Participants
n=3 Participants
|
16 Participants
n=6 Participants
|
4 Participants
n=114 Participants
|
4 Participants
|
2 Participants
n=19 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=2 Participants
|
1 Participants
n=102 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=5 Participants
|
9 Participants
n=15 Participants
|
6 Participants
n=138 Participants
|
4 Participants
n=4 Participants
|
91 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
20 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
159 Participants
n=30 Participants
|
124 Participants
n=3 Participants
|
141 Participants
n=6 Participants
|
36 Participants
n=114 Participants
|
44 Participants
|
17 Participants
n=19 Participants
|
12 Participants
n=4 Participants
|
32 Participants
n=7 Participants
|
35 Participants
n=7 Participants
|
43 Participants
n=3 Participants
|
35 Participants
n=4 Participants
|
114 Participants
n=2 Participants
|
35 Participants
n=102 Participants
|
19 Participants
n=5 Participants
|
91 Participants
n=5 Participants
|
155 Participants
n=15 Participants
|
70 Participants
n=138 Participants
|
96 Participants
n=4 Participants
|
1310 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=138 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
6 Participants
n=30 Participants
|
14 Participants
n=3 Participants
|
8 Participants
n=6 Participants
|
7 Participants
n=114 Participants
|
7 Participants
|
1 Participants
n=19 Participants
|
2 Participants
n=4 Participants
|
14 Participants
n=7 Participants
|
12 Participants
n=7 Participants
|
10 Participants
n=3 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=2 Participants
|
20 Participants
n=102 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
25 Participants
n=15 Participants
|
12 Participants
n=138 Participants
|
34 Participants
n=4 Participants
|
183 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Dose Escalation: Baseline up to Week 3Population: DLT analysis set included all participants with data used for implementing the dose-escalation schedule. These participants should have received all study drug administrations in the DLT evaluation period, or should have stopped treatment because of DLTs in the DLT evaluation period.
DLT: defined using National Cancer Institute Common Toxicity Criteria for Adverse Events Version 4.0, as any one of following: any Grade (Gr) \>=3toxicity that is possibly/probably/ definitely related to avelumab, except for any of following: Gr 3 infusion-related reaction resolving within 6 hours and controlled with medical management, Transient Gr 3 flu-like symptoms/fever, which is controlled with medical management, Transient Gr 3 fatigue, local reactions, headache, nausea, emesis that resolves to \<= Gr 1, Gr3 diarrhea, Gr 3 skin toxicity, Gr 3 liver function test increase that resolves to \<= Gr1 in \< 7 days after medical management has been initiated, Single laboratory values out of normal range that were unlikely related to study treatment according to investigator, did not have any clinical correlate, and resolved to \<= Gr1 within 7 days with adequate medical management and tumor flare phenomenon defined as local pain, irritation/rash localized at sites of known/suspected tumor.
Outcome measures
| Measure |
Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)
Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)
Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 1.0 mg/kg
n=3 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 1.0 milligrams per kilogram (mg/kg) once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or investigational medicinal product (IMP) occurs.
|
Dose Escalation Cohort: Avelumab 3.0 mg/kg
n=3 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 3.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 10.0 mg/kg
n=6 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 20.0 mg/kg
n=6 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 20.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 10.0 mg/kg Weekly
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once weekly for the first 12 weeks and once every 2 weeks starting Week 13 in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: NSCLC, Post-platinum Doublet
Participants with non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: NSCLC, First Line
Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: Metastatic Breast Cancer
Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: GC/GEJC Progressed
Participants with gastric and gastroesophageal cancer who progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: GC/GEJC Non Progressed
Participants with gastric and gastroesophageal cancer who non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Colorectal Cancer
Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Castrate-resistant Prostate Cancer
Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Mesothelioma
Participants with mesothelioma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Urothelial Carcinoma
Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Ovarian Cancer
Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)
Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)
Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: Ovarian Cancer
Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: Urothelial Carcinoma
Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: GC/GEJC, Third Line
Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: HNSCC
Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Number of Participants Experiencing Dose Limiting Toxicities (DLTs)
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Ovarian Cancer Efficacy Expansion: Baseline up to Day 620Population: Full analysis set (FAS) included all participants who have received at least 1 dose of study treatment.
Confirmed BOR was determined according to RECIST 1.1 and as adjudicated by an Independent Endpoint Review Committee (IERC) and defined as best response of any of complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) recorded from date of randomization until disease progression/recurrence (taking smallest measurement recorded since start of treatment as reference). CR: Disappearance of all evidence of target/non-target lesions. PR: At least 30%reduction from baseline in sum of longest diameter (SLD) of all lesions. SD: Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD: at least a 20% increase in SLD, taking as reference smallest SLD recorded from baseline/appearance of 1or more new lesions and unequivocal progression of non-target lesions.
Outcome measures
| Measure |
Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)
Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)
Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 1.0 mg/kg
n=103 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 1.0 milligrams per kilogram (mg/kg) once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or investigational medicinal product (IMP) occurs.
|
Dose Escalation Cohort: Avelumab 3.0 mg/kg
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 3.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 10.0 mg/kg
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 20.0 mg/kg
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 20.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 10.0 mg/kg Weekly
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once weekly for the first 12 weeks and once every 2 weeks starting Week 13 in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: NSCLC, Post-platinum Doublet
Participants with non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: NSCLC, First Line
Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: Metastatic Breast Cancer
Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: GC/GEJC Progressed
Participants with gastric and gastroesophageal cancer who progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: GC/GEJC Non Progressed
Participants with gastric and gastroesophageal cancer who non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Colorectal Cancer
Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Castrate-resistant Prostate Cancer
Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Mesothelioma
Participants with mesothelioma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Urothelial Carcinoma
Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Ovarian Cancer
Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)
Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)
Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: Ovarian Cancer
Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: Urothelial Carcinoma
Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: GC/GEJC, Third Line
Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: HNSCC
Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Efficacy Expansion Cohort (Ovarian Cancer): Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), as Adjudicated by Independent Endpoint Review Committee (IERC)
Non-evaluable
|
—
|
—
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Efficacy Expansion Cohort (Ovarian Cancer): Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), as Adjudicated by Independent Endpoint Review Committee (IERC)
Complete response (CR)
|
—
|
—
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Efficacy Expansion Cohort (Ovarian Cancer): Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), as Adjudicated by Independent Endpoint Review Committee (IERC)
Partial response (PR)
|
—
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Efficacy Expansion Cohort (Ovarian Cancer): Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), as Adjudicated by Independent Endpoint Review Committee (IERC)
Stable disease (SD)
|
—
|
—
|
41 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Efficacy Expansion Cohort (Ovarian Cancer): Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), as Adjudicated by Independent Endpoint Review Committee (IERC)
Progressive disease (PD)
|
—
|
—
|
39 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Efficacy Expansion Cohort (Ovarian Cancer): Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), as Adjudicated by Independent Endpoint Review Committee (IERC)
Non-CR/Non-PD
|
—
|
—
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Urothelial Carcinoma Efficacy Expansion: Baseline up to Day 931Population: Full analysis set (FAS) included all participants who have received at least 1 dose of study treatment. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.
Confirmed BOR was determined according to RECIST 1.1 and as adjudicated by an Independent Endpoint Review Committee (IERC) and defined as best response of any of complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) recorded from date of randomization until disease progression/recurrence (taking smallest measurement recorded since start of treatment as reference). CR: Disappearance of all evidence of target/non-target lesions. PR: At least 30% reduction from baseline in sum of longest diameter (SLD) of all lesions. SD: Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD: at least a 20% increase in SLD, taking as reference smallest SLD recorded from baseline/appearance of 1 or more new lesions and unequivocal progression of non-target lesions.
Outcome measures
| Measure |
Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)
Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)
Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 1.0 mg/kg
n=198 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 1.0 milligrams per kilogram (mg/kg) once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or investigational medicinal product (IMP) occurs.
|
Dose Escalation Cohort: Avelumab 3.0 mg/kg
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 3.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 10.0 mg/kg
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 20.0 mg/kg
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 20.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 10.0 mg/kg Weekly
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once weekly for the first 12 weeks and once every 2 weeks starting Week 13 in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: NSCLC, Post-platinum Doublet
Participants with non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: NSCLC, First Line
Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: Metastatic Breast Cancer
Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: GC/GEJC Progressed
Participants with gastric and gastroesophageal cancer who progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: GC/GEJC Non Progressed
Participants with gastric and gastroesophageal cancer who non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Colorectal Cancer
Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Castrate-resistant Prostate Cancer
Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Mesothelioma
Participants with mesothelioma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Urothelial Carcinoma
Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Ovarian Cancer
Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)
Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)
Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: Ovarian Cancer
Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: Urothelial Carcinoma
Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: GC/GEJC, Third Line
Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: HNSCC
Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Efficacy Expansion Cohort(Urothelial Carcinoma): Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), as Adjudicated by Independent Endpoint Review Committee (IERC)
Complete response (CR)
|
—
|
—
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Efficacy Expansion Cohort(Urothelial Carcinoma): Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), as Adjudicated by Independent Endpoint Review Committee (IERC)
Partial response (PR)
|
—
|
—
|
26 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Efficacy Expansion Cohort(Urothelial Carcinoma): Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), as Adjudicated by Independent Endpoint Review Committee (IERC)
Stable disease (SD)
|
—
|
—
|
51 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Efficacy Expansion Cohort(Urothelial Carcinoma): Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), as Adjudicated by Independent Endpoint Review Committee (IERC)
Progressive disease (PD)
|
—
|
—
|
77 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Efficacy Expansion Cohort(Urothelial Carcinoma): Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), as Adjudicated by Independent Endpoint Review Committee (IERC)
Non-CR/Non-PD
|
—
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Efficacy Expansion Cohort(Urothelial Carcinoma): Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), as Adjudicated by Independent Endpoint Review Committee (IERC)
Non-evaluable
|
—
|
—
|
37 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: GC/GEJC, Third Line Efficacy Expansion: Baseline up to Day 871Population: Full analysis set (FAS) included all participants who have received at least 1 dose of study treatment.
Confirmed BOR was determined according to RECIST 1.1 and as adjudicated by an Independent Endpoint Review Committee (IERC) and defined as best response of any of complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) recorded from date of randomization until disease progression/recurrence (taking smallest measurement recorded since start of treatment as reference). CR: Disappearance of all evidence of target/non-target lesions. PR: At least 30% reduction from baseline in sum of longest diameter (SLD) of all lesions. SD: Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD: at least a 20% increase in SLD, taking as reference smallest SLD recorded from baseline/appearance of 1 or more new lesions and unequivocal progression of non-target lesions.
Outcome measures
| Measure |
Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)
Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)
Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 1.0 mg/kg
n=132 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 1.0 milligrams per kilogram (mg/kg) once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or investigational medicinal product (IMP) occurs.
|
Dose Escalation Cohort: Avelumab 3.0 mg/kg
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 3.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 10.0 mg/kg
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 20.0 mg/kg
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 20.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 10.0 mg/kg Weekly
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once weekly for the first 12 weeks and once every 2 weeks starting Week 13 in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: NSCLC, Post-platinum Doublet
Participants with non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: NSCLC, First Line
Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: Metastatic Breast Cancer
Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: GC/GEJC Progressed
Participants with gastric and gastroesophageal cancer who progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: GC/GEJC Non Progressed
Participants with gastric and gastroesophageal cancer who non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Colorectal Cancer
Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Castrate-resistant Prostate Cancer
Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Mesothelioma
Participants with mesothelioma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Urothelial Carcinoma
Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Ovarian Cancer
Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)
Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)
Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: Ovarian Cancer
Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: Urothelial Carcinoma
Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: GC/GEJC, Third Line
Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: HNSCC
Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Efficacy Expansion Cohort (GC/GEJC, Third Line): Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), as Adjudicated by Independent Endpoint Review Committee (IERC)
Complete response (CR)
|
—
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Efficacy Expansion Cohort (GC/GEJC, Third Line): Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), as Adjudicated by Independent Endpoint Review Committee (IERC)
Partial response (PR)
|
—
|
—
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Efficacy Expansion Cohort (GC/GEJC, Third Line): Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), as Adjudicated by Independent Endpoint Review Committee (IERC)
Stable disease (SD)
|
—
|
—
|
24 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Efficacy Expansion Cohort (GC/GEJC, Third Line): Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), as Adjudicated by Independent Endpoint Review Committee (IERC)
Progressive disease (PD)
|
—
|
—
|
72 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Efficacy Expansion Cohort (GC/GEJC, Third Line): Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), as Adjudicated by Independent Endpoint Review Committee (IERC)
Non-CR/Non-PD
|
—
|
—
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Efficacy Expansion Cohort (GC/GEJC, Third Line): Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), as Adjudicated by Independent Endpoint Review Committee (IERC)
Non-evaluable
|
—
|
—
|
24 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: HNSCC Efficacy Expansion: Baseline up to Day 1072Population: Full analysis set (FAS) included all participants who have received at least 1 dose of study treatment.
Confirmed BOR was determined according to RECIST 1.1 and as adjudicated by an Independent Endpoint Review Committee (IERC) and defined as best response of any of complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) recorded from date of randomization until disease progression/recurrence (taking smallest measurement recorded since start of treatment as reference). CR: Disappearance of all evidence of target/non-target lesions. PR: At least 30%reduction from baseline in sum of longest diameter (SLD) of all lesions. SD: Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD: at least a 20% increase in SLD, taking as reference smallest SLD recorded from baseline/appearance of 1or more new lesions and unequivocal progression of non-target lesions.
Outcome measures
| Measure |
Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)
Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)
Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 1.0 mg/kg
n=153 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 1.0 milligrams per kilogram (mg/kg) once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or investigational medicinal product (IMP) occurs.
|
Dose Escalation Cohort: Avelumab 3.0 mg/kg
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 3.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 10.0 mg/kg
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 20.0 mg/kg
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 20.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 10.0 mg/kg Weekly
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once weekly for the first 12 weeks and once every 2 weeks starting Week 13 in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: NSCLC, Post-platinum Doublet
Participants with non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: NSCLC, First Line
Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: Metastatic Breast Cancer
Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: GC/GEJC Progressed
Participants with gastric and gastroesophageal cancer who progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: GC/GEJC Non Progressed
Participants with gastric and gastroesophageal cancer who non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Colorectal Cancer
Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Castrate-resistant Prostate Cancer
Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Mesothelioma
Participants with mesothelioma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Urothelial Carcinoma
Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Ovarian Cancer
Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)
Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)
Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: Ovarian Cancer
Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: Urothelial Carcinoma
Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: GC/GEJC, Third Line
Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: HNSCC
Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Efficacy Expansion Cohort (HNSCC): Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), as Adjudicated by Independent Endpoint Review Committee (IERC)
Complete response (CR)
|
—
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Efficacy Expansion Cohort (HNSCC): Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), as Adjudicated by Independent Endpoint Review Committee (IERC)
Partial response (PR)
|
—
|
—
|
12 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Efficacy Expansion Cohort (HNSCC): Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), as Adjudicated by Independent Endpoint Review Committee (IERC)
Stable disease (SD)
|
—
|
—
|
46 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Efficacy Expansion Cohort (HNSCC): Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), as Adjudicated by Independent Endpoint Review Committee (IERC)
Progressive disease (PD)
|
—
|
—
|
67 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Efficacy Expansion Cohort (HNSCC): Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), as Adjudicated by Independent Endpoint Review Committee (IERC)
Non-CR/Non-PD
|
—
|
—
|
1 Participants
|
—
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—
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—
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—
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—
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—
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—
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Efficacy Expansion Cohort (HNSCC): Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), as Adjudicated by Independent Endpoint Review Committee (IERC)
Non-evaluable
|
—
|
—
|
25 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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—
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—
|
—
|
—
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—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 2511Population: Safety analysis set (SAF) included all participants who have received at least 1 dose of study treatment.
Adverse event(AE): any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of study drug, whether or not related to study drug. A serious adverse event(SAE) was an AE that resulted in any of following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment-emergent events were events between first dose of study drug that were absent before treatment or that worsened relative to pre-treatment state up to 30 days after last administration.TEAEs included both Serious TEAEs and non-serious TEAEs. Severity of TEAEs were graded using National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0 toxicity grades, as follows: Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death.
Outcome measures
| Measure |
Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)
n=50 Participants
Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)
n=51 Participants
Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 1.0 mg/kg
n=4 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 1.0 milligrams per kilogram (mg/kg) once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or investigational medicinal product (IMP) occurs.
|
Dose Escalation Cohort: Avelumab 3.0 mg/kg
n=13 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 3.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 10.0 mg/kg
n=15 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 20.0 mg/kg
n=21 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 20.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 10.0 mg/kg Weekly
n=8 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once weekly for the first 12 weeks and once every 2 weeks starting Week 13 in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: NSCLC, Post-platinum Doublet
n=184 Participants
Participants with non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: NSCLC, First Line
n=156 Participants
Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: Metastatic Breast Cancer
n=168 Participants
Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: GC/GEJC Progressed
n=60 Participants
Participants with gastric and gastroesophageal cancer who progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: GC/GEJC Non Progressed
n=90 Participants
Participants with gastric and gastroesophageal cancer who non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Colorectal Cancer
n=21 Participants
Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Castrate-resistant Prostate Cancer
n=18 Participants
Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Mesothelioma
n=53 Participants
Participants with mesothelioma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Urothelial Carcinoma
n=44 Participants
Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Ovarian Cancer
n=125 Participants
Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)
n=62 Participants
Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)
n=20 Participants
Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: Ovarian Cancer
n=103 Participants
Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: Urothelial Carcinoma
n=205 Participants
Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: GC/GEJC, Third Line
n=132 Participants
Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: HNSCC
n=153 Participants
Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation and Expansion Cohorts: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and TEAEs as Per Severity
Participants with TEAEs with Grade 3 severity
|
25 Participants
|
21 Participants
|
2 Participants
|
4 Participants
|
6 Participants
|
11 Participants
|
3 Participants
|
66 Participants
|
68 Participants
|
45 Participants
|
29 Participants
|
41 Participants
|
6 Participants
|
7 Participants
|
23 Participants
|
18 Participants
|
42 Participants
|
20 Participants
|
10 Participants
|
45 Participants
|
82 Participants
|
51 Participants
|
54 Participants
|
|
Dose Escalation and Expansion Cohorts: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and TEAEs as Per Severity
Participants with TEAEs with Grade 4 severity
|
8 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
19 Participants
|
15 Participants
|
12 Participants
|
7 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
6 Participants
|
3 Participants
|
6 Participants
|
1 Participants
|
6 Participants
|
16 Participants
|
12 Participants
|
12 Participants
|
|
Dose Escalation and Expansion Cohorts: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and TEAEs as Per Severity
Participants with TEAEs with Grade 5 severity
|
6 Participants
|
5 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
32 Participants
|
25 Participants
|
24 Participants
|
10 Participants
|
10 Participants
|
3 Participants
|
0 Participants
|
4 Participants
|
7 Participants
|
14 Participants
|
4 Participants
|
2 Participants
|
15 Participants
|
45 Participants
|
35 Participants
|
25 Participants
|
|
Dose Escalation and Expansion Cohorts: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and TEAEs as Per Severity
Participants with TEAEs with missing Grade
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Dose Escalation and Expansion Cohorts: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and TEAEs as Per Severity
Participants with TEAEs
|
50 Participants
|
50 Participants
|
4 Participants
|
13 Participants
|
15 Participants
|
21 Participants
|
8 Participants
|
182 Participants
|
156 Participants
|
161 Participants
|
60 Participants
|
88 Participants
|
21 Participants
|
17 Participants
|
53 Participants
|
44 Participants
|
122 Participants
|
62 Participants
|
19 Participants
|
103 Participants
|
204 Participants
|
130 Participants
|
149 Participants
|
|
Dose Escalation and Expansion Cohorts: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and TEAEs as Per Severity
Participants with TEAEs with Grade 1 severity
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
11 Participants
|
3 Participants
|
22 Participants
|
5 Participants
|
14 Participants
|
2 Participants
|
5 Participants
|
2 Participants
|
3 Participants
|
11 Participants
|
7 Participants
|
1 Participants
|
7 Participants
|
15 Participants
|
2 Participants
|
14 Participants
|
|
Dose Escalation and Expansion Cohorts: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and TEAEs as Per Severity
Participants with TEAEs with Grade 2 severity
|
10 Participants
|
17 Participants
|
0 Participants
|
4 Participants
|
4 Participants
|
6 Participants
|
3 Participants
|
54 Participants
|
45 Participants
|
58 Participants
|
9 Participants
|
19 Participants
|
9 Participants
|
5 Participants
|
21 Participants
|
10 Participants
|
52 Participants
|
25 Participants
|
5 Participants
|
30 Participants
|
46 Participants
|
30 Participants
|
43 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Day 2511Population: SAF included all participants who have received at least 1 dose of study treatment.
AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not related to study drug. Treatment-emergent events were the events between first dose of study drug that were absent before treatment or that worsened relative to pre-treatment state up to 30 days after last administration. TEAEs included both Serious TEAEs and non-serious TEAEs. Treatment related AE was defined as having a "Possible" or "Related" relationship to study treatment, as assessed by the Investigator. Severity of Treatment-Related TEAEs were graded using NCI-CTCAE version 4.0 toxicity grades, as follows: Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death.
Outcome measures
| Measure |
Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)
n=50 Participants
Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)
n=51 Participants
Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 1.0 mg/kg
n=4 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 1.0 milligrams per kilogram (mg/kg) once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or investigational medicinal product (IMP) occurs.
|
Dose Escalation Cohort: Avelumab 3.0 mg/kg
n=13 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 3.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 10.0 mg/kg
n=15 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 20.0 mg/kg
n=21 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 20.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 10.0 mg/kg Weekly
n=8 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once weekly for the first 12 weeks and once every 2 weeks starting Week 13 in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: NSCLC, Post-platinum Doublet
n=184 Participants
Participants with non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: NSCLC, First Line
n=156 Participants
Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: Metastatic Breast Cancer
n=168 Participants
Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: GC/GEJC Progressed
n=60 Participants
Participants with gastric and gastroesophageal cancer who progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: GC/GEJC Non Progressed
n=90 Participants
Participants with gastric and gastroesophageal cancer who non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Colorectal Cancer
n=21 Participants
Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Castrate-resistant Prostate Cancer
n=18 Participants
Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Mesothelioma
n=53 Participants
Participants with mesothelioma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Urothelial Carcinoma
n=44 Participants
Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Ovarian Cancer
n=125 Participants
Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)
n=62 Participants
Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)
n=20 Participants
Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: Ovarian Cancer
n=103 Participants
Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: Urothelial Carcinoma
n=205 Participants
Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: GC/GEJC, Third Line
n=132 Participants
Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: HNSCC
n=153 Participants
Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation and Expansion Cohorts: Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs as Per Severity
Participants with Treatment-Related TEAEs with Grade 1 severity
|
12 Participants
|
15 Participants
|
1 Participants
|
5 Participants
|
7 Participants
|
6 Participants
|
2 Participants
|
46 Participants
|
29 Participants
|
52 Participants
|
14 Participants
|
27 Participants
|
4 Participants
|
8 Participants
|
8 Participants
|
11 Participants
|
46 Participants
|
20 Participants
|
4 Participants
|
30 Participants
|
50 Participants
|
25 Participants
|
39 Participants
|
|
Dose Escalation and Expansion Cohorts: Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs as Per Severity
Participants with Treatment-Related TEAEs with missing Grade
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Dose Escalation and Expansion Cohorts: Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs as Per Severity
Participants with Treatment-Related TEAEs
|
41 Participants
|
39 Participants
|
3 Participants
|
9 Participants
|
14 Participants
|
17 Participants
|
7 Participants
|
146 Participants
|
109 Participants
|
118 Participants
|
28 Participants
|
57 Participants
|
16 Participants
|
15 Participants
|
43 Participants
|
32 Participants
|
86 Participants
|
51 Participants
|
14 Participants
|
65 Participants
|
144 Participants
|
71 Participants
|
83 Participants
|
|
Dose Escalation and Expansion Cohorts: Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs as Per Severity
Participants with Treatment-Related TEAEs with Grade 2 severity
|
21 Participants
|
20 Participants
|
1 Participants
|
4 Participants
|
3 Participants
|
8 Participants
|
4 Participants
|
71 Participants
|
60 Participants
|
46 Participants
|
9 Participants
|
22 Participants
|
9 Participants
|
6 Participants
|
30 Participants
|
18 Participants
|
31 Participants
|
23 Participants
|
9 Participants
|
26 Participants
|
70 Participants
|
33 Participants
|
34 Participants
|
|
Dose Escalation and Expansion Cohorts: Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs as Per Severity
Participants with Treatment-Related TEAEs with Grade 3 severity
|
8 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
21 Participants
|
17 Participants
|
13 Participants
|
4 Participants
|
7 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
7 Participants
|
3 Participants
|
1 Participants
|
8 Participants
|
20 Participants
|
11 Participants
|
9 Participants
|
|
Dose Escalation and Expansion Cohorts: Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs as Per Severity
Participants with Treatment-Related TEAEs with Grade 4 severity
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
8 Participants
|
3 Participants
|
5 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
5 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Dose Escalation and Expansion Cohorts: Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs as Per Severity
Participants with Treatment-Related TEAEs with Grade 5 severity
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Pre-infusion, at end of 1-hour infusion (Day 1), 0.5, 1, 2, 4, 6,12, 24, 36, 48 hours after end of infusionPopulation: Pharmacokinetic (PK) population included all participants who have completed at least 1 infusion of study drug, and who have provided sufficient concentration measurements.
Area under the serum concentration versus time curve from time zero to the last sampling time t at which the concentration is at or above the lower limit of quantification (LLLQ). AUC(0-t) was calculated according to the mixed log-linear trapezoidal rule.
Outcome measures
| Measure |
Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)
Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)
Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 1.0 mg/kg
n=4 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 1.0 milligrams per kilogram (mg/kg) once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or investigational medicinal product (IMP) occurs.
|
Dose Escalation Cohort: Avelumab 3.0 mg/kg
n=13 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 3.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 10.0 mg/kg
n=15 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 20.0 mg/kg
n=21 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 20.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 10.0 mg/kg Weekly
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once weekly for the first 12 weeks and once every 2 weeks starting Week 13 in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: NSCLC, Post-platinum Doublet
Participants with non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: NSCLC, First Line
Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: Metastatic Breast Cancer
Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: GC/GEJC Progressed
Participants with gastric and gastroesophageal cancer who progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: GC/GEJC Non Progressed
Participants with gastric and gastroesophageal cancer who non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Colorectal Cancer
Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Castrate-resistant Prostate Cancer
Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Mesothelioma
Participants with mesothelioma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Urothelial Carcinoma
Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Ovarian Cancer
Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)
Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)
Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: Ovarian Cancer
Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: Urothelial Carcinoma
Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: GC/GEJC, Third Line
Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: HNSCC
Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Area Under Serum Concentration-Time Curve From the Time of Dosing to the Time of the Last Observation (AUC0-t) of Avelumab
|
—
|
—
|
1040 Hours*micrograms per milliliter
Standard Deviation 443
|
6080 Hours*micrograms per milliliter
Standard Deviation 1970
|
22749.4 Hours*micrograms per milliliter
Standard Deviation 7857.09
|
45100 Hours*micrograms per milliliter
Standard Deviation 15600
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SECONDARY outcome
Timeframe: Pre-infusion, at end of 1-hour infusion (Day 1), 0.5, 1, 2, 4, 6,12, 24, 36, 48 hours after end of infusionPopulation: Pharmacokinetic (PK) population included all participants who have completed at least 1 infusion of study drug, and who have provided sufficient concentration measurements. Here "Overall number of participants analyzed" signifies those who were evaluable for this outcome measure.
The AUC(0-inf) was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity.
Outcome measures
| Measure |
Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)
Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)
Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 1.0 mg/kg
n=2 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 1.0 milligrams per kilogram (mg/kg) once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or investigational medicinal product (IMP) occurs.
|
Dose Escalation Cohort: Avelumab 3.0 mg/kg
n=12 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 3.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 10.0 mg/kg
n=13 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 20.0 mg/kg
n=15 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 20.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 10.0 mg/kg Weekly
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once weekly for the first 12 weeks and once every 2 weeks starting Week 13 in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: NSCLC, Post-platinum Doublet
Participants with non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: NSCLC, First Line
Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: Metastatic Breast Cancer
Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: GC/GEJC Progressed
Participants with gastric and gastroesophageal cancer who progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: GC/GEJC Non Progressed
Participants with gastric and gastroesophageal cancer who non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Colorectal Cancer
Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Castrate-resistant Prostate Cancer
Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Mesothelioma
Participants with mesothelioma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Urothelial Carcinoma
Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Ovarian Cancer
Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)
Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)
Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: Ovarian Cancer
Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: Urothelial Carcinoma
Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: GC/GEJC, Third Line
Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: HNSCC
Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUC0-infinity) of Avelumab
|
—
|
—
|
1290 Hours*micrograms per milliliter
Standard Deviation 650
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6850 Hours*micrograms per milliliter
Standard Deviation 2100
|
25920.9 Hours*micrograms per milliliter
Standard Deviation 6753.76
|
46600 Hours*micrograms per milliliter
Standard Deviation 18500
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—
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SECONDARY outcome
Timeframe: Pre-infusion, at end of 1-hour infusion (Day 1), 0.5, 1, 2, 4, 6,12, 24, 36, 48 hours after end of infusionPopulation: Pharmacokinetic (PK) population included all participants who have completed at least 1 infusion of study drug, and who have provided sufficient concentration measurements.
Cmax is the maximum observed serum concentration obtained directly from the concentration versus time curve.
Outcome measures
| Measure |
Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)
Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)
Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 1.0 mg/kg
n=4 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 1.0 milligrams per kilogram (mg/kg) once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or investigational medicinal product (IMP) occurs.
|
Dose Escalation Cohort: Avelumab 3.0 mg/kg
n=13 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 3.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 10.0 mg/kg
n=15 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 20.0 mg/kg
n=21 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 20.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 10.0 mg/kg Weekly
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once weekly for the first 12 weeks and once every 2 weeks starting Week 13 in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: NSCLC, Post-platinum Doublet
Participants with non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: NSCLC, First Line
Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: Metastatic Breast Cancer
Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: GC/GEJC Progressed
Participants with gastric and gastroesophageal cancer who progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: GC/GEJC Non Progressed
Participants with gastric and gastroesophageal cancer who non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Colorectal Cancer
Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Castrate-resistant Prostate Cancer
Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Mesothelioma
Participants with mesothelioma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Urothelial Carcinoma
Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Ovarian Cancer
Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)
Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)
Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: Ovarian Cancer
Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: Urothelial Carcinoma
Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: GC/GEJC, Third Line
Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: HNSCC
Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Maximum Observed Serum Concentration (Cmax) of Avelumab
|
—
|
—
|
18.7 Micrograms per milliliter (mcg/mL)
Standard Deviation 3.96
|
81.9 Micrograms per milliliter (mcg/mL)
Standard Deviation 22.1
|
249.048 Micrograms per milliliter (mcg/mL)
Standard Deviation 55.4697
|
489 Micrograms per milliliter (mcg/mL)
Standard Deviation 140
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—
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—
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—
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—
|
SECONDARY outcome
Timeframe: Pre-infusion, at end of 1-hour infusion (Day 1), 0.5, 1, 2, 4, 6,12, 24, 36, 48 hours after end of infusionPopulation: Pharmacokinetic (PK) population included all participants who have completed at least 1 infusion of study drug, and who have provided sufficient concentration measurements.
Tmax is time to reach maximum observed serum concentration obtained directly from the concentration versus time curve.
Outcome measures
| Measure |
Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)
Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)
Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 1.0 mg/kg
n=4 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 1.0 milligrams per kilogram (mg/kg) once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or investigational medicinal product (IMP) occurs.
|
Dose Escalation Cohort: Avelumab 3.0 mg/kg
n=13 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 3.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 10.0 mg/kg
n=15 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 20.0 mg/kg
n=21 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 20.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 10.0 mg/kg Weekly
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once weekly for the first 12 weeks and once every 2 weeks starting Week 13 in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: NSCLC, Post-platinum Doublet
Participants with non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: NSCLC, First Line
Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: Metastatic Breast Cancer
Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: GC/GEJC Progressed
Participants with gastric and gastroesophageal cancer who progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: GC/GEJC Non Progressed
Participants with gastric and gastroesophageal cancer who non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Colorectal Cancer
Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Castrate-resistant Prostate Cancer
Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Mesothelioma
Participants with mesothelioma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Urothelial Carcinoma
Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Ovarian Cancer
Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)
Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)
Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: Ovarian Cancer
Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: Urothelial Carcinoma
Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: GC/GEJC, Third Line
Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: HNSCC
Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Time to Reach Maximum Observed Serum Concentration (Tmax) of Avelumab
|
—
|
—
|
1.500 Hours
Interval 1.02 to 13.0
|
1.500 Hours
Interval 1.0 to 13.0
|
1.500 Hours
Interval 1.0 to 7.1
|
1.717 Hours
Interval 0.95 to 13.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-infusion, at end of 1-hour infusion (Day 1), 0.5, 1, 2, 4, 6,12, 24, 36, 48 hours after end of infusionPopulation: Pharmacokinetic (PK) population included all participants who have completed at least 1 infusion of study drug, and who have provided sufficient concentration measurements. Here "Overall number of participants analyzed" signifies those who were evaluable for this outcome measure.
Apparent terminal half-life was defined as the time required for the serum concentration of drug to decrease 50 percent in the final stage of its elimination.
Outcome measures
| Measure |
Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)
Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)
Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 1.0 mg/kg
n=2 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 1.0 milligrams per kilogram (mg/kg) once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or investigational medicinal product (IMP) occurs.
|
Dose Escalation Cohort: Avelumab 3.0 mg/kg
n=12 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 3.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 10.0 mg/kg
n=13 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 20.0 mg/kg
n=15 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 20.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 10.0 mg/kg Weekly
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once weekly for the first 12 weeks and once every 2 weeks starting Week 13 in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: NSCLC, Post-platinum Doublet
Participants with non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: NSCLC, First Line
Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: Metastatic Breast Cancer
Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: GC/GEJC Progressed
Participants with gastric and gastroesophageal cancer who progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: GC/GEJC Non Progressed
Participants with gastric and gastroesophageal cancer who non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Colorectal Cancer
Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Castrate-resistant Prostate Cancer
Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Mesothelioma
Participants with mesothelioma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Urothelial Carcinoma
Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Ovarian Cancer
Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)
Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)
Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: Ovarian Cancer
Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: Urothelial Carcinoma
Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: GC/GEJC, Third Line
Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: HNSCC
Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Apparent Terminal Half-Life (t1/2) of Avelumab
|
—
|
—
|
61.425 Hours
Interval 46.06 to 76.79
|
89.064 Hours
Interval 43.09 to 115.95
|
97.440 Hours
Interval 52.15 to 120.08
|
108.671 Hours
Interval 55.95 to 133.84
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 1, 15, 29, 43, 85, 127 and 169Population: Pharmacokinetic analysis set was used. Here "Overall number of participants analyzed" signifies those who were evaluable for this outcome measure and "Number analyzed" signifies those who were evaluable at specified time points. Data was reported for those arms for which end of infusion sample were collected as per planned analysis.
Serum concentration at end of infusion (CEOI) of Avelumab is reported.
Outcome measures
| Measure |
Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)
Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)
Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 1.0 mg/kg
n=117 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 1.0 milligrams per kilogram (mg/kg) once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or investigational medicinal product (IMP) occurs.
|
Dose Escalation Cohort: Avelumab 3.0 mg/kg
n=18 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 3.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 10.0 mg/kg
n=13 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 20.0 mg/kg
n=16 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 20.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 10.0 mg/kg Weekly
n=85 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once weekly for the first 12 weeks and once every 2 weeks starting Week 13 in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: NSCLC, Post-platinum Doublet
n=84 Participants
Participants with non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: NSCLC, First Line
n=29 Participants
Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: Metastatic Breast Cancer
n=124 Participants
Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: GC/GEJC Progressed
Participants with gastric and gastroesophageal cancer who progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: GC/GEJC Non Progressed
Participants with gastric and gastroesophageal cancer who non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Colorectal Cancer
Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Castrate-resistant Prostate Cancer
Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Mesothelioma
Participants with mesothelioma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Urothelial Carcinoma
Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Ovarian Cancer
Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)
Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)
Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: Ovarian Cancer
Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: Urothelial Carcinoma
Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: GC/GEJC, Third Line
Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: HNSCC
Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Expansion Phase: Serum Concentration at End of Infusion (CEOI) of Avelumab
Day 43
|
—
|
—
|
250 Microgram per milliliter
Standard Deviation 69.8
|
306 Microgram per milliliter
Standard Deviation 108
|
294 Microgram per milliliter
Standard Deviation 57.4
|
255 Microgram per milliliter
Standard Deviation 69.7
|
268 Microgram per milliliter
Standard Deviation 72.0
|
241 Microgram per milliliter
Standard Deviation 58.1
|
240 Microgram per milliliter
Standard Deviation 93.1
|
249 Microgram per milliliter
Standard Deviation 105
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Phase: Serum Concentration at End of Infusion (CEOI) of Avelumab
Day 85
|
—
|
—
|
266 Microgram per milliliter
Standard Deviation 79.5
|
216 Microgram per milliliter
Standard Deviation 24.9
|
348 Microgram per milliliter
Standard Deviation 65.6
|
252 Microgram per milliliter
Standard Deviation 78.9
|
263 Microgram per milliliter
Standard Deviation 66.4
|
247 Microgram per milliliter
Standard Deviation 66.4
|
237 Microgram per milliliter
Standard Deviation 5.54
|
255 Microgram per milliliter
Standard Deviation 57.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Phase: Serum Concentration at End of Infusion (CEOI) of Avelumab
Day 1
|
—
|
—
|
246 Microgram per milliliter
Standard Deviation 87.4
|
272 Microgram per milliliter
Standard Deviation 73.9
|
343 Microgram per milliliter
Standard Deviation 117
|
239 Microgram per milliliter
Standard Deviation 50.2
|
247 Microgram per milliliter
Standard Deviation 77.3
|
224 Microgram per milliliter
Standard Deviation 55.4
|
241 Microgram per milliliter
Standard Deviation 75.0
|
212 Microgram per milliliter
Standard Deviation 47.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Phase: Serum Concentration at End of Infusion (CEOI) of Avelumab
Day 15
|
—
|
—
|
—
|
297 Microgram per milliliter
Standard Deviation 99.6
|
305 Microgram per milliliter
Standard Deviation 88.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Phase: Serum Concentration at End of Infusion (CEOI) of Avelumab
Day 29
|
—
|
—
|
—
|
287 Microgram per milliliter
Standard Deviation 89.5
|
291 Microgram per milliliter
Standard Deviation 60.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Phase: Serum Concentration at End of Infusion (CEOI) of Avelumab
Day 169
|
—
|
—
|
304 Microgram per milliliter
Standard Deviation 64.9
|
272 Microgram per milliliter
|
287 Microgram per milliliter
|
235 Microgram per milliliter
|
233 Microgram per milliliter
Standard Deviation 90.4
|
313 Microgram per milliliter
Standard Deviation 59.3
|
—
|
245 Microgram per milliliter
Standard Deviation 51.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Phase: Serum Concentration at End of Infusion (CEOI) of Avelumab
Day 127
|
—
|
—
|
—
|
269 Microgram per milliliter
Standard Deviation 45.4
|
339 Microgram per milliliter
Standard Deviation 41.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 15, 29, 43, 57, 71, 85, 99, 127 and 169Population: Pharmacokinetic analysis set was used. Here "Overall number of participants analyzed" signifies those who were evaluable for this outcome measure and "Number analyzed" signifies those who were evaluable at specified time points. Data for "primary expansion cohort: GC/GEJC Progressed" and "primary expansion cohort: GC/GEJC Non progressed" arms was reported as a single arm "primary expansion cohort: GC/GEJC Progressed/Non progressed" for this outcome measure as per planned analysis.
Serum Ctrough concentration of Avelumab is reported.
Outcome measures
| Measure |
Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)
n=118 Participants
Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)
n=21 Participants
Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 1.0 mg/kg
n=163 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 1.0 milligrams per kilogram (mg/kg) once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or investigational medicinal product (IMP) occurs.
|
Dose Escalation Cohort: Avelumab 3.0 mg/kg
n=124 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 3.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 10.0 mg/kg
n=129 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 20.0 mg/kg
n=154 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 20.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 10.0 mg/kg Weekly
n=32 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once weekly for the first 12 weeks and once every 2 weeks starting Week 13 in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: NSCLC, Post-platinum Doublet
n=17 Participants
Participants with non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: NSCLC, First Line
n=13 Participants
Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: Metastatic Breast Cancer
n=45 Participants
Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: GC/GEJC Progressed
n=48 Participants
Participants with gastric and gastroesophageal cancer who progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: GC/GEJC Non Progressed
n=57 Participants
Participants with gastric and gastroesophageal cancer who non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Colorectal Cancer
n=17 Participants
Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Castrate-resistant Prostate Cancer
n=43 Participants
Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Mesothelioma
n=117 Participants
Participants with mesothelioma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Urothelial Carcinoma
n=87 Participants
Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Ovarian Cancer
n=82 Participants
Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)
Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)
Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: Ovarian Cancer
Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: Urothelial Carcinoma
Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: GC/GEJC, Third Line
Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: HNSCC
Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Expansion Phase: Minimum Serum Post-dose (Ctrough) Concentration of Avelumab
Day 15
|
23.1 Microgram per milliliter
Standard Deviation 14.1
|
18.1 Microgram per milliliter
Standard Deviation 12.4
|
20.4 Microgram per milliliter
Standard Deviation 16.1
|
18.3 Microgram per milliliter
Standard Deviation 10.3
|
22.5 Microgram per milliliter
Standard Deviation 11.1
|
23.7 Microgram per milliliter
Standard Deviation 24.6
|
17.8 Microgram per milliliter
Standard Deviation 9.51
|
22.4 Microgram per milliliter
Standard Deviation 14.1
|
28.8 Microgram per milliliter
Standard Deviation 14.5
|
22.3 Microgram per milliliter
Standard Deviation 13.4
|
21.7 Microgram per milliliter
Standard Deviation 26.7
|
26.9 Microgram per milliliter
Standard Deviation 14.4
|
25.1 Microgram per milliliter
Standard Deviation 11.6
|
21.3 Microgram per milliliter
Standard Deviation 12.0
|
20.1 Microgram per milliliter
Standard Deviation 10.1
|
22.3 Microgram per milliliter
Standard Deviation 11.1
|
17.6 Microgram per milliliter
Standard Deviation 10.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Phase: Minimum Serum Post-dose (Ctrough) Concentration of Avelumab
Day 29
|
27.7 Microgram per milliliter
Standard Deviation 18.3
|
18.6 Microgram per milliliter
Standard Deviation 16.0
|
23.5 Microgram per milliliter
Standard Deviation 15.4
|
23.5 Microgram per milliliter
Standard Deviation 15.1
|
25.6 Microgram per milliliter
Standard Deviation 15.2
|
26.5 Microgram per milliliter
Standard Deviation 17.0
|
17.3 Microgram per milliliter
Standard Deviation 13.6
|
25.5 Microgram per milliliter
Standard Deviation 20.1
|
31.6 Microgram per milliliter
Standard Deviation 15.9
|
23.8 Microgram per milliliter
Standard Deviation 17.3
|
20.7 Microgram per milliliter
Standard Deviation 12.4
|
35.7 Microgram per milliliter
Standard Deviation 22.3
|
27.4 Microgram per milliliter
Standard Deviation 16.6
|
26.2 Microgram per milliliter
Standard Deviation 16.9
|
27.0 Microgram per milliliter
Standard Deviation 23.9
|
23.9 Microgram per milliliter
Standard Deviation 16.2
|
21.3 Microgram per milliliter
Standard Deviation 13.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Phase: Minimum Serum Post-dose (Ctrough) Concentration of Avelumab
Day 43
|
28.4 Microgram per milliliter
Standard Deviation 20.9
|
19.8 Microgram per milliliter
Standard Deviation 21.5
|
24.6 Microgram per milliliter
Standard Deviation 15.6
|
23.8 Microgram per milliliter
Standard Deviation 15.9
|
28.3 Microgram per milliliter
Standard Deviation 18.2
|
29.7 Microgram per milliliter
Standard Deviation 17.8
|
20.6 Microgram per milliliter
Standard Deviation 14.3
|
23.2 Microgram per milliliter
Standard Deviation 24.2
|
32.3 Microgram per milliliter
Standard Deviation 16.3
|
29.3 Microgram per milliliter
Standard Deviation 22.9
|
23.6 Microgram per milliliter
Standard Deviation 18.9
|
35.7 Microgram per milliliter
Standard Deviation 22.6
|
29.4 Microgram per milliliter
Standard Deviation 19.7
|
28.1 Microgram per milliliter
Standard Deviation 18.9
|
29.0 Microgram per milliliter
Standard Deviation 17.6
|
27.7 Microgram per milliliter
Standard Deviation 18.1
|
25.2 Microgram per milliliter
Standard Deviation 17.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Phase: Minimum Serum Post-dose (Ctrough) Concentration of Avelumab
Day 85
|
39.1 Microgram per milliliter
Standard Deviation 28.3
|
19.3 Microgram per milliliter
Standard Deviation 3.60
|
27.8 Microgram per milliliter
Standard Deviation 18.9
|
27.7 Microgram per milliliter
Standard Deviation 16.7
|
29.7 Microgram per milliliter
Standard Deviation 18.1
|
28.9 Microgram per milliliter
Standard Deviation 16.8
|
24.9 Microgram per milliliter
Standard Deviation 29.0
|
8.03 Microgram per milliliter
Standard Deviation 0.988
|
37.9 Microgram per milliliter
Standard Deviation 18.3
|
35.6 Microgram per milliliter
Standard Deviation 23.7
|
23.7 Microgram per milliliter
Standard Deviation 15.8
|
39.7 Microgram per milliliter
Standard Deviation 27.2
|
34.4 Microgram per milliliter
Standard Deviation 20.2
|
34.7 Microgram per milliliter
Standard Deviation 20.5
|
35.6 Microgram per milliliter
Standard Deviation 20.7
|
31.2 Microgram per milliliter
Standard Deviation 22.0
|
28.0 Microgram per milliliter
Standard Deviation 14.6
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Phase: Minimum Serum Post-dose (Ctrough) Concentration of Avelumab
Day 99
|
—
|
—
|
—
|
28.8 Microgram per milliliter
Standard Deviation 13.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Phase: Minimum Serum Post-dose (Ctrough) Concentration of Avelumab
Day 127
|
40.7 Microgram per milliliter
Standard Deviation 25.1
|
—
|
36.9 Microgram per milliliter
Standard Deviation 24.0
|
—
|
39.1 Microgram per milliliter
Standard Deviation 40.2
|
33.1 Microgram per milliliter
Standard Deviation 24.0
|
28.8 Microgram per milliliter
Standard Deviation 22.1
|
34.2 Microgram per milliliter
|
44.2 Microgram per milliliter
Standard Deviation 12.7
|
58.6 Microgram per milliliter
Standard Deviation 76.7
|
25.9 Microgram per milliliter
Standard Deviation 11.3
|
—
|
—
|
35.7 Microgram per milliliter
Standard Deviation 18.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Phase: Minimum Serum Post-dose (Ctrough) Concentration of Avelumab
Day 169
|
49.3 Microgram per milliliter
Standard Deviation 27.3
|
—
|
36.6 Microgram per milliliter
Standard Deviation 25.8
|
39.1 Microgram per milliliter
Standard Deviation 19.8
|
31.4 Microgram per milliliter
Standard Deviation 18.2
|
31.9 Microgram per milliliter
Standard Deviation 14.0
|
24.7 Microgram per milliliter
Standard Deviation 28.1
|
10.5 Microgram per milliliter
|
—
|
35.3 Microgram per milliliter
Standard Deviation 20.2
|
28.7 Microgram per milliliter
Standard Deviation 11.4
|
47.1 Microgram per milliliter
Standard Deviation 26.8
|
43.6 Microgram per milliliter
|
38.8 Microgram per milliliter
Standard Deviation 19.2
|
32.5 Microgram per milliliter
Standard Deviation 14.7
|
28.3 Microgram per milliliter
Standard Deviation 20.0
|
37.3 Microgram per milliliter
Standard Deviation 31.6
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Phase: Minimum Serum Post-dose (Ctrough) Concentration of Avelumab
Day 57
|
27.3 Microgram per milliliter
Standard Deviation 21.5
|
16.2 Microgram per milliliter
Standard Deviation 15.2
|
26.2 Microgram per milliliter
Standard Deviation 17.3
|
23.4 Microgram per milliliter
Standard Deviation 16.1
|
26.5 Microgram per milliliter
Standard Deviation 14.1
|
28.9 Microgram per milliliter
Standard Deviation 14.5
|
22.2 Microgram per milliliter
Standard Deviation 19.8
|
—
|
—
|
29.9 Microgram per milliliter
Standard Deviation 22.4
|
18.2 Microgram per milliliter
Standard Deviation 11.7
|
39.8 Microgram per milliliter
Standard Deviation 25.5
|
25.5 Microgram per milliliter
Standard Deviation 18.7
|
29.7 Microgram per milliliter
Standard Deviation 22.8
|
30.6 Microgram per milliliter
Standard Deviation 18.1
|
28.5 Microgram per milliliter
Standard Deviation 20.3
|
24.1 Microgram per milliliter
Standard Deviation 15.6
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Phase: Minimum Serum Post-dose (Ctrough) Concentration of Avelumab
Day 71
|
33.4 Microgram per milliliter
Standard Deviation 31.8
|
19.6 Microgram per milliliter
Standard Deviation 15.3
|
27.9 Microgram per milliliter
Standard Deviation 36.5
|
31.0 Microgram per milliliter
Standard Deviation 40.1
|
28.1 Microgram per milliliter
Standard Deviation 16.6
|
29.9 Microgram per milliliter
Standard Deviation 15.4
|
22.0 Microgram per milliliter
Standard Deviation 15.5
|
—
|
—
|
28.8 Microgram per milliliter
Standard Deviation 23.6
|
21.0 Microgram per milliliter
Standard Deviation 14.2
|
38.4 Microgram per milliliter
Standard Deviation 33.4
|
27.8 Microgram per milliliter
Standard Deviation 17.6
|
29.4 Microgram per milliliter
Standard Deviation 22.1
|
31.1 Microgram per milliliter
Standard Deviation 18.8
|
30.4 Microgram per milliliter
Standard Deviation 23.0
|
24.2 Microgram per milliliter
Standard Deviation 14.7
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Dose Escalation: Baseline up to Day 1023Population: Safety analysis set included all participants who have received at least 1 dose of study treatment.
irBOR defined as best response of any of immune related complete response (irCR), immune related partial response (irPR), immune related stable disease (irSD) and immune related progressive disease (irPD) recorded from baseline until immune related disease progression and determined according to modified irRC per investigator assessment. irCR: Complete disappearance of all tumor lesions (both index and non-index lesions with no new measurable/unmeasurable lesions). irPR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions). irSD: SLD of target and new measurable lesions neither irCR, irPR, or irPD. irPD: SLD of target and new measurable lesions increases greater than or equal to \[\>=\] 20%, confirmed by a repeat, consecutive observations at least 4 weeks from the date first documented. Number of participants with immune-related best overall response in each category (irCR, irPR, irSD, irPD) was reported.
Outcome measures
| Measure |
Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)
Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)
Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 1.0 mg/kg
n=4 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 1.0 milligrams per kilogram (mg/kg) once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or investigational medicinal product (IMP) occurs.
|
Dose Escalation Cohort: Avelumab 3.0 mg/kg
n=13 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 3.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 10.0 mg/kg
n=15 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 20.0 mg/kg
n=21 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 20.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 10.0 mg/kg Weekly
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once weekly for the first 12 weeks and once every 2 weeks starting Week 13 in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: NSCLC, Post-platinum Doublet
Participants with non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: NSCLC, First Line
Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: Metastatic Breast Cancer
Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: GC/GEJC Progressed
Participants with gastric and gastroesophageal cancer who progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: GC/GEJC Non Progressed
Participants with gastric and gastroesophageal cancer who non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Colorectal Cancer
Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Castrate-resistant Prostate Cancer
Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Mesothelioma
Participants with mesothelioma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Urothelial Carcinoma
Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Ovarian Cancer
Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)
Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)
Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: Ovarian Cancer
Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: Urothelial Carcinoma
Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: GC/GEJC, Third Line
Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: HNSCC
Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Number of Participants With Immune Related Best Overall Response (irBOR) According to Modified Immune-Related Response Criteria (irRC)
Immune-related Complete Response
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Number of Participants With Immune Related Best Overall Response (irBOR) According to Modified Immune-Related Response Criteria (irRC)
Immune-related Partial Response
|
—
|
—
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Number of Participants With Immune Related Best Overall Response (irBOR) According to Modified Immune-Related Response Criteria (irRC)
Immune-related Stable Disease
|
—
|
—
|
2 Participants
|
8 Participants
|
8 Participants
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Number of Participants With Immune Related Best Overall Response (irBOR) According to Modified Immune-Related Response Criteria (irRC)
Immune-related Progressive Disease
|
—
|
—
|
0 Participants
|
5 Participants
|
4 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Number of Participants With Immune Related Best Overall Response (irBOR) According to Modified Immune-Related Response Criteria (irRC)
Not Evaluable
|
—
|
—
|
2 Participants
|
0 Participants
|
2 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Dose Expansion: Baseline up to Day 2023Population: Full analysis set (FAS) included all participants who have received at least 1 dose of study treatment. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.
irBOR defined as best response of any of immune related complete response (irCR), immune related partial response (irPR), immune related stable disease (irSD) and immune related progressive disease (irPD) recorded from baseline until immune related disease progression and determined according to modified irRC per investigator assessment. irCR: Complete disappearance of all tumor lesions (both index and non-index lesions with no new measurable/unmeasurable lesions). irPR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions). irSD: SLD of target and new measurable lesions neither irCR, irPR, or irPD. irPD: SLD of target and new measurable lesions increases greater than or equal to \[\>=\] 20%, confirmed by a repeat, consecutive observations at least 4 weeks from the date first documented. Number of participants with immune-related best overall response in each category (irCR, irPR, irSD, irPD) was reported.
Outcome measures
| Measure |
Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)
n=62 Participants
Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)
n=20 Participants
Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 1.0 mg/kg
n=184 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 1.0 milligrams per kilogram (mg/kg) once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or investigational medicinal product (IMP) occurs.
|
Dose Escalation Cohort: Avelumab 3.0 mg/kg
n=156 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 3.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 10.0 mg/kg
n=168 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 20.0 mg/kg
n=60 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 20.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 10.0 mg/kg Weekly
n=90 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once weekly for the first 12 weeks and once every 2 weeks starting Week 13 in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: NSCLC, Post-platinum Doublet
n=21 Participants
Participants with non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: NSCLC, First Line
n=18 Participants
Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: Metastatic Breast Cancer
n=50 Participants
Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: GC/GEJC Progressed
n=51 Participants
Participants with gastric and gastroesophageal cancer who progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: GC/GEJC Non Progressed
n=53 Participants
Participants with gastric and gastroesophageal cancer who non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Colorectal Cancer
n=44 Participants
Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Castrate-resistant Prostate Cancer
n=125 Participants
Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Mesothelioma
n=103 Participants
Participants with mesothelioma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Urothelial Carcinoma
n=198 Participants
Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Ovarian Cancer
n=132 Participants
Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)
n=153 Participants
Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)
Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: Ovarian Cancer
Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: Urothelial Carcinoma
Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: GC/GEJC, Third Line
Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: HNSCC
Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Expansion Cohort: Number of Participants With Immune Related Best Overall Response (irBOR) According to Modified Immune-Related Response Criteria (irRC)
Immune-related Partial Response
|
10 Participants
|
2 Participants
|
26 Participants
|
31 Participants
|
6 Participants
|
5 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
7 Participants
|
4 Participants
|
5 Participants
|
15 Participants
|
4 Participants
|
24 Participants
|
7 Participants
|
15 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Cohort: Number of Participants With Immune Related Best Overall Response (irBOR) According to Modified Immune-Related Response Criteria (irRC)
Immune-related Complete Response
|
1 Participants
|
0 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
10 Participants
|
1 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Cohort: Number of Participants With Immune Related Best Overall Response (irBOR) According to Modified Immune-Related Response Criteria (irRC)
Not Evaluable
|
5 Participants
|
2 Participants
|
40 Participants
|
22 Participants
|
32 Participants
|
35 Participants
|
31 Participants
|
7 Participants
|
14 Participants
|
7 Participants
|
9 Participants
|
7 Participants
|
6 Participants
|
21 Participants
|
19 Participants
|
41 Participants
|
33 Participants
|
27 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Cohort: Number of Participants With Immune Related Best Overall Response (irBOR) According to Modified Immune-Related Response Criteria (irRC)
Immune-related Stable Disease
|
40 Participants
|
15 Participants
|
80 Participants
|
78 Participants
|
60 Participants
|
20 Participants
|
53 Participants
|
9 Participants
|
3 Participants
|
26 Participants
|
20 Participants
|
31 Participants
|
21 Participants
|
61 Participants
|
44 Participants
|
61 Participants
|
29 Participants
|
61 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Cohort: Number of Participants With Immune Related Best Overall Response (irBOR) According to Modified Immune-Related Response Criteria (irRC)
Immune-related Progressive Disease
|
6 Participants
|
1 Participants
|
36 Participants
|
21 Participants
|
69 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
1 Participants
|
14 Participants
|
11 Participants
|
10 Participants
|
10 Participants
|
27 Participants
|
33 Participants
|
62 Participants
|
62 Participants
|
44 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Dose Escalation: Baseline up to Day 2511Population: Safety analysis set included all participants who have received at least 1 dose of study treatment.
BOR was determined according to RECIST v1.1 and as per investigator assessment. BOR is defined as the best response of any of complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) recorded from date of randomization until disease progression or recurrence (taking the smallest measurement recorded since start of treatment as reference). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in the sum of the longest diameter (SLD) of all lesions. SD =Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD is defined as at least a 20 % increase in the SLD, taking as reference the smallest SLD recorded from baseline or appearance of 1 or more new lesions and unequivocal progression of non-target lesions. Number of participants with best overall response in each category (CR, PR, SD, PD) was reported.
Outcome measures
| Measure |
Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)
Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)
Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 1.0 mg/kg
n=4 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 1.0 milligrams per kilogram (mg/kg) once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or investigational medicinal product (IMP) occurs.
|
Dose Escalation Cohort: Avelumab 3.0 mg/kg
n=13 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 3.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 10.0 mg/kg
n=15 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 20.0 mg/kg
n=21 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 20.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 10.0 mg/kg Weekly
n=8 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once weekly for the first 12 weeks and once every 2 weeks starting Week 13 in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: NSCLC, Post-platinum Doublet
Participants with non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: NSCLC, First Line
Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: Metastatic Breast Cancer
Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: GC/GEJC Progressed
Participants with gastric and gastroesophageal cancer who progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: GC/GEJC Non Progressed
Participants with gastric and gastroesophageal cancer who non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Colorectal Cancer
Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Castrate-resistant Prostate Cancer
Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Mesothelioma
Participants with mesothelioma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Urothelial Carcinoma
Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Ovarian Cancer
Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)
Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)
Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: Ovarian Cancer
Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: Urothelial Carcinoma
Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: GC/GEJC, Third Line
Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: HNSCC
Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation Cohort: Number of Participants With Best Overall Response (BOR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Complete Response
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation Cohort: Number of Participants With Best Overall Response (BOR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Partial Response
|
—
|
—
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation Cohort: Number of Participants With Best Overall Response (BOR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Stable Disease
|
—
|
—
|
2 Participants
|
8 Participants
|
8 Participants
|
14 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation Cohort: Number of Participants With Best Overall Response (BOR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Progressive Disease
|
—
|
—
|
0 Participants
|
5 Participants
|
4 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation Cohort: Number of Participants With Best Overall Response (BOR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Not Evaluable
|
—
|
—
|
2 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Dose Expansion: Baseline up to Day 2023Population: Full analysis set (FAS) included all participants who have received at least 1 dose of study treatment. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.
BOR was determined according to RECIST v1.1 and as per investigator assessment. BOR is defined as the best response of any of complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) recorded from date of randomization until disease progression or recurrence (taking the smallest measurement recorded since start of treatment as reference). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in the sum of the longest diameter (SLD) of all lesions. SD = Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD is defined as at least a 20 % increase in the SLD, taking as reference the smallest SLD recorded from baseline or appearance of 1 or more new lesions and unequivocal progression of non-target lesions. Number of participants with best overall response in each category (CR, PR, SD, PD) was reported.
Outcome measures
| Measure |
Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)
n=62 Participants
Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)
n=20 Participants
Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 1.0 mg/kg
n=184 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 1.0 milligrams per kilogram (mg/kg) once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or investigational medicinal product (IMP) occurs.
|
Dose Escalation Cohort: Avelumab 3.0 mg/kg
n=156 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 3.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 10.0 mg/kg
n=168 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 20.0 mg/kg
n=60 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 20.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 10.0 mg/kg Weekly
n=90 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once weekly for the first 12 weeks and once every 2 weeks starting Week 13 in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: NSCLC, Post-platinum Doublet
n=21 Participants
Participants with non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: NSCLC, First Line
n=18 Participants
Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: Metastatic Breast Cancer
n=50 Participants
Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: GC/GEJC Progressed
n=51 Participants
Participants with gastric and gastroesophageal cancer who progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: GC/GEJC Non Progressed
n=53 Participants
Participants with gastric and gastroesophageal cancer who non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Colorectal Cancer
n=44 Participants
Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Castrate-resistant Prostate Cancer
n=125 Participants
Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Mesothelioma
n=103 Participants
Participants with mesothelioma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Urothelial Carcinoma
n=198 Participants
Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Ovarian Cancer
n=132 Participants
Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)
n=153 Participants
Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)
Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: Ovarian Cancer
Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: Urothelial Carcinoma
Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: GC/GEJC, Third Line
Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: HNSCC
Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Expansion Cohort: Number of Participants With Best Overall Response (BOR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Complete Response
|
1 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
7 Participants
|
1 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Cohort: Number of Participants With Best Overall Response (BOR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Partial Response
|
9 Participants
|
2 Participants
|
24 Participants
|
28 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
7 Participants
|
4 Participants
|
4 Participants
|
11 Participants
|
4 Participants
|
24 Participants
|
7 Participants
|
15 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Cohort: Number of Participants With Best Overall Response (BOR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Stable Disease
|
38 Participants
|
13 Participants
|
66 Participants
|
68 Participants
|
41 Participants
|
13 Participants
|
45 Participants
|
9 Participants
|
10 Participants
|
21 Participants
|
16 Participants
|
26 Participants
|
20 Participants
|
53 Participants
|
37 Participants
|
45 Participants
|
23 Participants
|
50 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Cohort: Number of Participants With Best Overall Response (BOR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Progressive Disease
|
11 Participants
|
4 Participants
|
68 Participants
|
40 Participants
|
107 Participants
|
36 Participants
|
29 Participants
|
9 Participants
|
5 Participants
|
22 Participants
|
17 Participants
|
18 Participants
|
14 Participants
|
51 Participants
|
46 Participants
|
87 Participants
|
80 Participants
|
66 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Cohort: Number of Participants With Best Overall Response (BOR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Not Evaluable
|
3 Participants
|
1 Participants
|
24 Participants
|
17 Participants
|
15 Participants
|
7 Participants
|
10 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
7 Participants
|
4 Participants
|
4 Participants
|
9 Participants
|
13 Participants
|
35 Participants
|
21 Participants
|
17 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Secondary Urothelial Carcinoma Dose Expansion: Baseline up to Day 931Population: FAS included all participants who have received at least 1 dose of study treatment. This outcome measure was planned to be analyzed in Secondary Urothelial Carcinoma Cohort only.
Confirmed Best Overall Response (BOR) was determined according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1and as adjudicated by an Independent Endpoint Review Committee (IERC) is defined as best response of any of complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) recorded from date of randomization until disease progression/recurrence (taking smallest measurement recorded since start of treatment as reference). CR: Disappearance of all evidence of target/non-target lesions. PR: At least 30% reduction from baseline in sum of longest diameter (SLD) of all lesions. SD: Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD: at least a 20% increase in SLD, taking as reference smallest SLD recorded from baseline/appearance of 1or more new lesions and unequivocal progression of non-target lesions. Number of participants with BOR in each category (CR, PR, SD, PD) were reported.
Outcome measures
| Measure |
Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)
Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)
Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 1.0 mg/kg
n=44 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 1.0 milligrams per kilogram (mg/kg) once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or investigational medicinal product (IMP) occurs.
|
Dose Escalation Cohort: Avelumab 3.0 mg/kg
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 3.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 10.0 mg/kg
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 20.0 mg/kg
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 20.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 10.0 mg/kg Weekly
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once weekly for the first 12 weeks and once every 2 weeks starting Week 13 in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: NSCLC, Post-platinum Doublet
Participants with non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: NSCLC, First Line
Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: Metastatic Breast Cancer
Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: GC/GEJC Progressed
Participants with gastric and gastroesophageal cancer who progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: GC/GEJC Non Progressed
Participants with gastric and gastroesophageal cancer who non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Colorectal Cancer
Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Castrate-resistant Prostate Cancer
Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Mesothelioma
Participants with mesothelioma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Urothelial Carcinoma
Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Ovarian Cancer
Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)
Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)
Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: Ovarian Cancer
Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: Urothelial Carcinoma
Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: GC/GEJC, Third Line
Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: HNSCC
Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Expansion Cohort (Secondary Urothelial Carcinoma Cohort): Number of Participants With Confirmed Best Overall Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 as Adjudicated by an Independent Endpoint Review Committee
Complete Response
|
—
|
—
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Cohort (Secondary Urothelial Carcinoma Cohort): Number of Participants With Confirmed Best Overall Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 as Adjudicated by an Independent Endpoint Review Committee
Partial Response
|
—
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Cohort (Secondary Urothelial Carcinoma Cohort): Number of Participants With Confirmed Best Overall Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 as Adjudicated by an Independent Endpoint Review Committee
Stable Disease
|
—
|
—
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Cohort (Secondary Urothelial Carcinoma Cohort): Number of Participants With Confirmed Best Overall Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 as Adjudicated by an Independent Endpoint Review Committee
Non-CR/Non-PD
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Cohort (Secondary Urothelial Carcinoma Cohort): Number of Participants With Confirmed Best Overall Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 as Adjudicated by an Independent Endpoint Review Committee
Progressive Disease
|
—
|
—
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Cohort (Secondary Urothelial Carcinoma Cohort): Number of Participants With Confirmed Best Overall Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 as Adjudicated by an Independent Endpoint Review Committee
Not Evaluable
|
—
|
—
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Dose Expansion: Baseline up to Day 2023Population: FAS included all participants who have received at least 1 dose of study treatment. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.
The PFS time (based on investigator assessments), according to the RECIST 1.1, was defined as the time from first administration of study treatment until first documentation of progressive disease (PD) or death when death occurred within 12 weeks of the last tumor assessment or first administration of study treatment (whichever was later). PD was defined as at least a 20% increase in the sum of longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions and unequivocal progression of non-target lesions. The analysis of PFS was performed with a Kaplan-Meier method.
Outcome measures
| Measure |
Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)
n=62 Participants
Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)
n=20 Participants
Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 1.0 mg/kg
n=184 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 1.0 milligrams per kilogram (mg/kg) once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or investigational medicinal product (IMP) occurs.
|
Dose Escalation Cohort: Avelumab 3.0 mg/kg
n=156 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 3.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 10.0 mg/kg
n=168 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 20.0 mg/kg
n=60 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 20.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 10.0 mg/kg Weekly
n=90 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once weekly for the first 12 weeks and once every 2 weeks starting Week 13 in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: NSCLC, Post-platinum Doublet
n=21 Participants
Participants with non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: NSCLC, First Line
n=18 Participants
Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: Metastatic Breast Cancer
n=50 Participants
Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: GC/GEJC Progressed
n=51 Participants
Participants with gastric and gastroesophageal cancer who progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: GC/GEJC Non Progressed
n=53 Participants
Participants with gastric and gastroesophageal cancer who non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Colorectal Cancer
n=44 Participants
Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Castrate-resistant Prostate Cancer
n=125 Participants
Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Mesothelioma
n=103 Participants
Participants with mesothelioma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Urothelial Carcinoma
n=198 Participants
Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Ovarian Cancer
n=132 Participants
Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)
n=153 Participants
Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)
Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: Ovarian Cancer
Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: Urothelial Carcinoma
Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: GC/GEJC, Third Line
Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: HNSCC
Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Expansion Cohort: Progression-Free Survival (PFS) Time According to Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1
|
8.28 Months
Interval 5.52 to 9.53
|
5.55 Months
Interval 2.33 to 9.63
|
2.66 Months
Interval 1.91 to 2.79
|
4.04 Months
Interval 2.66 to 5.42
|
1.35 Months
Interval 1.35 to 1.38
|
1.38 Months
Interval 1.31 to 1.48
|
2.76 Months
Interval 2.27 to 4.07
|
1.41 Months
Interval 1.38 to 5.52
|
5.39 Months
Interval 1.41 to 5.52
|
2.56 Months
Interval 1.38 to 3.98
|
3.06 Months
Interval 1.41 to 6.28
|
4.11 Months
Interval 1.41 to 6.18
|
2.69 Months
Interval 1.68 to 4.14
|
2.60 Months
Interval 1.41 to 2.76
|
1.45 Months
Interval 1.38 to 2.6
|
1.41 Months
Interval 1.38 to 1.74
|
1.31 Months
Interval 1.28 to 1.38
|
1.77 Months
Interval 1.38 to 2.69
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Dose Expansion: Baseline up to Day 2023Population: FAS included all participants who have received at least 1 dose of study treatment. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.
The irPFS time was defined as the time from first administration of study treatment until first documentation of immune-related progressive disease (irPD) or death when death occurred within 12 weeks of the last tumor assessment or first administration of study treatment (whichever was later). irPD: sum of the longest diameters of target and new measurable lesions increases greater than or equal to \[\>=\] 20%, confirmed by a repeat, consecutive observations at least 4 weeks from the date first documented. The analysis of irPFS will be performed with a Kaplan-Meier method. Data for immune related progression-free survival time has been reported.
Outcome measures
| Measure |
Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)
n=62 Participants
Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)
n=20 Participants
Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 1.0 mg/kg
n=184 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 1.0 milligrams per kilogram (mg/kg) once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or investigational medicinal product (IMP) occurs.
|
Dose Escalation Cohort: Avelumab 3.0 mg/kg
n=156 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 3.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 10.0 mg/kg
n=168 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 20.0 mg/kg
n=60 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 20.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 10.0 mg/kg Weekly
n=90 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once weekly for the first 12 weeks and once every 2 weeks starting Week 13 in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: NSCLC, Post-platinum Doublet
n=21 Participants
Participants with non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: NSCLC, First Line
n=18 Participants
Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: Metastatic Breast Cancer
n=50 Participants
Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: GC/GEJC Progressed
n=51 Participants
Participants with gastric and gastroesophageal cancer who progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: GC/GEJC Non Progressed
n=53 Participants
Participants with gastric and gastroesophageal cancer who non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Colorectal Cancer
n=44 Participants
Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Castrate-resistant Prostate Cancer
n=125 Participants
Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Mesothelioma
n=103 Participants
Participants with mesothelioma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Urothelial Carcinoma
n=198 Participants
Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Ovarian Cancer
n=132 Participants
Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)
n=153 Participants
Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)
Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: Ovarian Cancer
Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: Urothelial Carcinoma
Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: GC/GEJC, Third Line
Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: HNSCC
Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Expansion Cohort: Immune Related Progression-Free Survival (irPFS) Time According to Modified Immune-Related Response Criteria (irRC)
|
8.34 Months
Interval 5.98 to 13.04
|
6.90 Months
Interval 2.69 to 11.24
|
4.04 Months
Interval 2.76 to 5.49
|
6.93 Months
Interval 5.42 to 9.69
|
1.64 Months
Interval 1.38 to 2.5
|
1.81 Months
Interval 1.35 to 2.53
|
4.14 Months
Interval 2.76 to 5.95
|
2.79 Months
Interval 1.41 to 5.82
|
NA Months
Interval 1.38 to
Due to small number of events, estimates (Median and upper limit of 95% confidence interval) from Kaplan-Meier survival curves could not derive.
|
3.81 Months
Interval 2.4 to 5.49
|
6.83 Months
Interval 2.79 to 11.04
|
6.18 Months
Interval 3.94 to 12.45
|
4.07 Months
Interval 2.63 to 9.46
|
4.04 Months
Interval 2.69 to 5.42
|
2.60 Months
Interval 1.51 to 3.84
|
2.46 Months
Interval 1.48 to 2.76
|
1.35 Months
Interval 1.31 to 1.41
|
2.83 Months
Interval 2.66 to 4.14
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Dose Expansion: Baseline up to Day 2023Population: FAS included all participants who have received at least 1 dose of study treatment. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.
Overall survival time was measured as time in months first administration of trial treatment to death. The analysis of OS time was performed with a Kaplan-Meier method.
Outcome measures
| Measure |
Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)
n=62 Participants
Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)
n=20 Participants
Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 1.0 mg/kg
n=184 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 1.0 milligrams per kilogram (mg/kg) once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or investigational medicinal product (IMP) occurs.
|
Dose Escalation Cohort: Avelumab 3.0 mg/kg
n=156 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 3.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 10.0 mg/kg
n=168 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 20.0 mg/kg
n=60 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 20.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 10.0 mg/kg Weekly
n=90 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once weekly for the first 12 weeks and once every 2 weeks starting Week 13 in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: NSCLC, Post-platinum Doublet
n=21 Participants
Participants with non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: NSCLC, First Line
n=18 Participants
Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: Metastatic Breast Cancer
n=50 Participants
Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: GC/GEJC Progressed
n=51 Participants
Participants with gastric and gastroesophageal cancer who progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: GC/GEJC Non Progressed
n=53 Participants
Participants with gastric and gastroesophageal cancer who non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Colorectal Cancer
n=44 Participants
Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Castrate-resistant Prostate Cancer
n=125 Participants
Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Mesothelioma
n=103 Participants
Participants with mesothelioma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Urothelial Carcinoma
n=198 Participants
Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Ovarian Cancer
n=132 Participants
Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)
n=153 Participants
Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)
Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: Ovarian Cancer
Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: Urothelial Carcinoma
Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: GC/GEJC, Third Line
Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: HNSCC
Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Expansion Cohort: Overall Survival (OS) Time
|
NA Months
Due to small number of events, estimates (Median, lower and upper limit of 95% confidence interval) from Kaplan-Meier survival curves could not derive.
|
16.85 Months
Interval 8.34 to
Due to small number of events, estimate (upper limit of 95% confidence interval) from Kaplan-Meier survival curves could not derive.
|
8.57 Months
Interval 7.26 to 11.56
|
14.23 Months
Interval 11.33 to 16.85
|
8.38 Months
Interval 6.47 to 11.07
|
6.64 Months
Interval 5.39 to 9.43
|
11.07 Months
Interval 8.94 to 13.67
|
11.20 Months
Interval 5.82 to 13.27
|
19.32 Months
Interval 13.73 to
Due to small number of events, estimate (upper limit of 95% confidence interval) from Kaplan-Meier survival curves could not derive.
|
10.55 Months
Interval 7.39 to 15.01
|
17.22 Months
Interval 6.18 to
Due to small number of events, estimate (upper limit of 95% confidence interval) from Kaplan-Meier survival curves could not derive.
|
10.71 Months
Interval 6.44 to 20.24
|
13.70 Months
Interval 4.6 to 21.13
|
11.17 Months
Interval 8.74 to 15.44
|
9.13 Months
Interval 6.34 to 11.43
|
6.97 Months
Interval 5.85 to 8.41
|
3.35 Months
Interval 2.86 to 4.47
|
7.98 Months
Interval 6.47 to 10.22
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-infusion on Day 1; 48 hours after infusion on Day 3; Pre-infusion on Days 15, 43, and 85Population: Safety analysis set included all participants who have received at least 1 dose of study treatment. Here "Overall number of participants analyzed" signifies those who were evaluable for this outcome measure and "number analyzed" signifies those who were evaluable for this outcome measure at specified time points.
Percentage of PD-L1 receptors occupied by avelumab on human lymphocytes (CD3+ T-cells) was assessed by flow cytometry on peripheral blood mononuclear cell (PBMC) samples. Greater than or equal to \[\>=\] 85 percent \[%\] of cell viability was required for reliable receptor occupancy assessment.
Outcome measures
| Measure |
Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)
Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)
Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 1.0 mg/kg
n=3 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 1.0 milligrams per kilogram (mg/kg) once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or investigational medicinal product (IMP) occurs.
|
Dose Escalation Cohort: Avelumab 3.0 mg/kg
n=7 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 3.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 10.0 mg/kg
n=4 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 20.0 mg/kg
n=6 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 20.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 10.0 mg/kg Weekly
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once weekly for the first 12 weeks and once every 2 weeks starting Week 13 in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: NSCLC, Post-platinum Doublet
Participants with non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: NSCLC, First Line
Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: Metastatic Breast Cancer
Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: GC/GEJC Progressed
Participants with gastric and gastroesophageal cancer who progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: GC/GEJC Non Progressed
Participants with gastric and gastroesophageal cancer who non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Colorectal Cancer
Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Castrate-resistant Prostate Cancer
Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Mesothelioma
Participants with mesothelioma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Urothelial Carcinoma
Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Ovarian Cancer
Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)
Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)
Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: Ovarian Cancer
Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: Urothelial Carcinoma
Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: GC/GEJC, Third Line
Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: HNSCC
Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Programmed Death Ligand 1 (PD-L1) Receptor Occupancy
Day 85
|
—
|
—
|
19.8 Percentage of receptors
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Programmed Death Ligand 1 (PD-L1) Receptor Occupancy
Day 1
|
—
|
—
|
—
|
0.0 Percentage of receptors
Standard Deviation 0.0
|
—
|
0.0 Percentage of receptors
Standard Deviation 0.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Programmed Death Ligand 1 (PD-L1) Receptor Occupancy
Day 3
|
—
|
—
|
92.5 Percentage of receptors
Standard Deviation 1.99
|
80.1 Percentage of receptors
Standard Deviation 14.43
|
—
|
84.7 Percentage of receptors
Standard Deviation 12.83
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Programmed Death Ligand 1 (PD-L1) Receptor Occupancy
Day 15
|
—
|
—
|
75.7 Percentage of receptors
Standard Deviation 22.12
|
90.0 Percentage of receptors
Standard Deviation 8.11
|
93.2 Percentage of receptors
Standard Deviation 1.29
|
85.0 Percentage of receptors
Standard Deviation 8.73
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Programmed Death Ligand 1 (PD-L1) Receptor Occupancy
Day 43
|
—
|
—
|
30.3 Percentage of receptors
|
96.8 Percentage of receptors
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Dose Expansion: Baseline up to Day 2023Population: Safety analysis set included all participants who have received at least 1 dose of study treatment. Here "number analyzed" signifies those participants who were evaluable for this outcome measure at specified category.
PD-L1 assessment was performed using immunohistochemistry. PD-L1 expression status was classified as positive or negative based on the following cut-offs: For tumor cells: Participants were considered PD-L1 expression positive (negative): - if at least (less than) 5% of the tumor cells show PD-L1 membrane staining \>= 1+, respectively. This was used as the primary cut-off; - if at least (less than) 25% of the tumor cells show PD-L1 membrane staining \>=2+, respectively. This was considered as secondary cut-off; - if at least (less than) 1% of the tumor cells show PD-L1 membrane staining \>=1+, respectively. This was used as the tertiary cut-off; - if at least (less than) 50% of the tumor cells show PD-L1 membrane staining \>=1+, respectively. This was used as the '50% cut-off'; - if at least (less than) 80% of the tumor cells show PD-L1 membrane staining ≥1+, respectively. This was used as the '80% cut-off'.
Outcome measures
| Measure |
Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)
n=62 Participants
Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)
n=20 Participants
Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 1.0 mg/kg
n=184 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 1.0 milligrams per kilogram (mg/kg) once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or investigational medicinal product (IMP) occurs.
|
Dose Escalation Cohort: Avelumab 3.0 mg/kg
n=156 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 3.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 10.0 mg/kg
n=168 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 20.0 mg/kg
n=60 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 20.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 10.0 mg/kg Weekly
n=90 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once weekly for the first 12 weeks and once every 2 weeks starting Week 13 in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: NSCLC, Post-platinum Doublet
n=21 Participants
Participants with non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: NSCLC, First Line
n=18 Participants
Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: Metastatic Breast Cancer
n=50 Participants
Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: GC/GEJC Progressed
n=51 Participants
Participants with gastric and gastroesophageal cancer who progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: GC/GEJC Non Progressed
n=53 Participants
Participants with gastric and gastroesophageal cancer who non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Colorectal Cancer
n=44 Participants
Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Castrate-resistant Prostate Cancer
n=125 Participants
Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Mesothelioma
n=103 Participants
Participants with mesothelioma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Urothelial Carcinoma
n=205 Participants
Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Ovarian Cancer
n=132 Participants
Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)
n=153 Participants
Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)
Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: Ovarian Cancer
Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: Urothelial Carcinoma
Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: GC/GEJC, Third Line
Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: HNSCC
Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Expansion Cohort: Number of Participants With Positive Programmed Death Receptor-1 Ligand-1 (PD-L1) Biomarker Expression in Tumor Tissue
PD-L1 expression status - 1% cutoff
|
20 Participants
|
4 Participants
|
122 Participants
|
88 Participants
|
87 Participants
|
20 Participants
|
26 Participants
|
5 Participants
|
0 Participants
|
15 Participants
|
19 Participants
|
22 Participants
|
14 Participants
|
76 Participants
|
45 Participants
|
87 Participants
|
39 Participants
|
107 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Cohort: Number of Participants With Positive Programmed Death Receptor-1 Ligand-1 (PD-L1) Biomarker Expression in Tumor Tissue
PD-L1 expression status - 50% cutoff
|
1 Participants
|
0 Participants
|
54 Participants
|
53 Participants
|
13 Participants
|
—
|
—
|
1 Participants
|
0 Participants
|
5 Participants
|
8 Participants
|
5 Participants
|
5 Participants
|
2 Participants
|
4 Participants
|
34 Participants
|
—
|
51 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Cohort: Number of Participants With Positive Programmed Death Receptor-1 Ligand-1 (PD-L1) Biomarker Expression in Tumor Tissue
PD-L1 expression status - 80% cutoff
|
0 Participants
|
0 Participants
|
41 Participants
|
38 Participants
|
—
|
—
|
—
|
—
|
0 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
25 Participants
|
—
|
28 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Cohort: Number of Participants With Positive Programmed Death Receptor-1 Ligand-1 (PD-L1) Biomarker Expression in Tumor Tissue
PD-L1 expression status - 5% cutoff
|
11 Participants
|
1 Participants
|
84 Participants
|
76 Participants
|
25 Participants
|
—
|
—
|
1 Participants
|
0 Participants
|
12 Participants
|
15 Participants
|
16 Participants
|
13 Participants
|
32 Participants
|
23 Participants
|
72 Participants
|
16 Participants
|
93 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Cohort: Number of Participants With Positive Programmed Death Receptor-1 Ligand-1 (PD-L1) Biomarker Expression in Tumor Tissue
PD-L1 expression status - 25% cutoff
|
2 Participants
|
0 Participants
|
53 Participants
|
50 Participants
|
3 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
3 Participants
|
7 Participants
|
8 Participants
|
5 Participants
|
3 Participants
|
6 Participants
|
25 Participants
|
6 Participants
|
48 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 13Population: Efficacy analysis set included all participants who have received at least 1 dose of study treatment and have measurable disease at baseline according to investigator assessment. This outcome measure was planned to be analyzed in Primary expansion cohorts only
The response criteria evaluation was carried out according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. CR and PR did not need to be confirmed by a subsequent tumor assessment due to blinded central assessment. CR: Disappearance of all target lesions since baseline; PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters; SD: Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR and PD: at least a 20% increase in SLD, taking as reference smallest SLD recorded from baseline/appearance of 1or more new lesions and unequivocal progression of non-target lesions. Number of participants with unconfirmed response at week 13 according to response evaluation criteria in solid tumors (RECIST) version 1.1 were reported.
Outcome measures
| Measure |
Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)
Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)
Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 1.0 mg/kg
n=184 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 1.0 milligrams per kilogram (mg/kg) once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or investigational medicinal product (IMP) occurs.
|
Dose Escalation Cohort: Avelumab 3.0 mg/kg
n=156 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 3.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 10.0 mg/kg
n=168 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 20.0 mg/kg
n=60 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 20.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 10.0 mg/kg Weekly
n=90 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once weekly for the first 12 weeks and once every 2 weeks starting Week 13 in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: NSCLC, Post-platinum Doublet
Participants with non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: NSCLC, First Line
Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: Metastatic Breast Cancer
Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: GC/GEJC Progressed
Participants with gastric and gastroesophageal cancer who progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: GC/GEJC Non Progressed
Participants with gastric and gastroesophageal cancer who non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Colorectal Cancer
Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Castrate-resistant Prostate Cancer
Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Mesothelioma
Participants with mesothelioma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Urothelial Carcinoma
Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Ovarian Cancer
Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)
Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)
Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: Ovarian Cancer
Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: Urothelial Carcinoma
Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: GC/GEJC, Third Line
Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: HNSCC
Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Primary Expansion Cohorts: Number of Participants With Unconfirmed Response at Week 13 According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Unconfirmed Complete Response
|
—
|
—
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Primary Expansion Cohorts: Number of Participants With Unconfirmed Response at Week 13 According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Unconfirmed Partial Response
|
—
|
—
|
28 Participants
|
24 Participants
|
7 Participants
|
6 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Primary Expansion Cohorts: Number of Participants With Unconfirmed Response at Week 13 According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Unconfirmed Stable Disease
|
—
|
—
|
62 Participants
|
54 Participants
|
38 Participants
|
11 Participants
|
44 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Primary Expansion Cohorts: Number of Participants With Unconfirmed Response at Week 13 According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Unconfirmed Progressive Disease
|
—
|
—
|
68 Participants
|
28 Participants
|
107 Participants
|
37 Participants
|
31 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Primary Expansion Cohorts: Number of Participants With Unconfirmed Response at Week 13 According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Non-evaluable
|
—
|
—
|
24 Participants
|
49 Participants
|
15 Participants
|
6 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Dose Expansion: Baseline up to Day 2023Population: FAS included all participants who have received at least 1 dose of study treatment. Data for this outcome measure is reported for the participants with Complete or Partial response.
Duration of response according to RECIST 1.1, per investigator assessment was calculated for each participant with a confirmed response (complete response \[CR\] or partial response \[PR\]) as the time from the first observation of response to the first observation of documented disease progression (or death within 12 weeks of the last tumor assessment). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in the sum of the longest diameter (SLD) of all lesions. Results were calculated based on Kaplan-Meier estimates.
Outcome measures
| Measure |
Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)
n=10 Participants
Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)
n=2 Participants
Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 1.0 mg/kg
n=26 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 1.0 milligrams per kilogram (mg/kg) once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or investigational medicinal product (IMP) occurs.
|
Dose Escalation Cohort: Avelumab 3.0 mg/kg
n=31 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 3.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 10.0 mg/kg
n=5 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 20.0 mg/kg
n=4 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 20.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 10.0 mg/kg Weekly
n=6 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once weekly for the first 12 weeks and once every 2 weeks starting Week 13 in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: NSCLC, Post-platinum Doublet
Participants with non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: NSCLC, First Line
Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: Metastatic Breast Cancer
n=3 Participants
Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: GC/GEJC Progressed
n=11 Participants
Participants with gastric and gastroesophageal cancer who progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: GC/GEJC Non Progressed
n=5 Participants
Participants with gastric and gastroesophageal cancer who non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Colorectal Cancer
n=6 Participants
Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Castrate-resistant Prostate Cancer
n=12 Participants
Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Mesothelioma
n=7 Participants
Participants with mesothelioma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Urothelial Carcinoma
n=31 Participants
Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Ovarian Cancer
n=8 Participants
Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)
n=20 Participants
Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)
Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: Ovarian Cancer
Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: Urothelial Carcinoma
Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: GC/GEJC, Third Line
Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: HNSCC
Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Expansion Cohort: Duration of Response According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 Per Investigator Assessment
|
9.94 Months
Interval 2.79 to
Due to small number of events, estimate (upper limit of 95% confidence interval) from Kaplan-Meier survival curves could not derive.
|
NA Months
Interval 6.93 to
Due to small number of events, estimates (median and upper limit of 95% confidence interval) from Kaplan-Meier survival curves could not derive.
|
17.48 Months
Interval 6.93 to 21.39
|
12.02 Months
Interval 6.93 to 21.75
|
8.33 Months
Interval 6.6 to 22.67
|
3.48 Months
Interval 2.76 to 8.34
|
21.42 Months
Interval 4.04 to
Due to small number of events, estimate (upper limit of 95% confidence interval) from Kaplan-Meier survival curves could not derive.
|
—
|
—
|
8.41 Months
Interval 6.8 to
Due to small number of events, estimate (upper limit of 95% confidence interval) from Kaplan-Meier survival curves could not derive.
|
NA Months
Interval 2.63 to
Due to small number of events, estimates (median and upper limit of 95% confidence interval) from Kaplan-Meier survival curves could not derive.
|
15.21 Months
Interval 11.07 to
Due to small number of events, estimate (upper limit of 95% confidence interval) from Kaplan-Meier survival curves could not derive.
|
NA Months
As per planned analysis, data was analyzed in form of graph and no descriptive analysis was performed.
|
10.38 Months
Interval 4.17 to
Due to small number of events, estimate (upper limit of 95% confidence interval) from Kaplan-Meier survival curves could not derive.
|
NA Months
Interval 2.69 to
Due to small number of events, estimates (median and upper limit of 95% confidence interval) from Kaplan-Meier survival curves could not derive.
|
NA Months
As per planned analysis, data was analyzed in form of graph and no descriptive analysis was performed.
|
NA Months
Interval 2.79 to
Due to small number of events, estimates (median and upper limit of 95% confidence interval) from Kaplan-Meier survival curves could not derive.
|
NA Months
Interval 8.31 to
Due to small number of events, estimates (median and upper limit of 95% confidence interval) from Kaplan-Meier survival curves could not derive.
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Dose Expansion: Baseline up to Day 2023Population: FAS included all participants who have received at least 1 dose of study treatment. Data for this outcome measure is reported for the participants with Complete or Partial response.
Duration of response according to modified irRC, per investigator assessment was calculated for each participant with a confirmed response (immune-related complete response \[irCR\] or immune-related partial response \[irPR\]) as the time from the first observation of response to the first observation of documented disease progression (or death within 12 weeks of the last tumor assessment). irCR: Complete disappearance of all tumor lesions (both index and non-index lesions with no new measurable/unmeasurable lesions). irPR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions). Results were calculated based on Kaplan-Meier estimates.
Outcome measures
| Measure |
Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)
n=11 Participants
Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)
n=2 Participants
Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 1.0 mg/kg
n=28 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 1.0 milligrams per kilogram (mg/kg) once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or investigational medicinal product (IMP) occurs.
|
Dose Escalation Cohort: Avelumab 3.0 mg/kg
n=35 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 3.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 10.0 mg/kg
n=7 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 20.0 mg/kg
n=5 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 20.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 10.0 mg/kg Weekly
n=6 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once weekly for the first 12 weeks and once every 2 weeks starting Week 13 in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: NSCLC, Post-platinum Doublet
Participants with non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: NSCLC, First Line
Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: Metastatic Breast Cancer
n=3 Participants
Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: GC/GEJC Progressed
n=11 Participants
Participants with gastric and gastroesophageal cancer who progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: GC/GEJC Non Progressed
n=5 Participants
Participants with gastric and gastroesophageal cancer who non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Colorectal Cancer
n=7 Participants
Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Castrate-resistant Prostate Cancer
n=16 Participants
Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Mesothelioma
n=7 Participants
Participants with mesothelioma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Urothelial Carcinoma
n=34 Participants
Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Ovarian Cancer
n=8 Participants
Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)
n=21 Participants
Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)
Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: Ovarian Cancer
Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: Urothelial Carcinoma
Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: GC/GEJC, Third Line
Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: HNSCC
Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Expansion Cohort: Duration of Response According to Modified Immune-Related Response Criteria (irRC) Per Investigator Assessment
|
10.61 Months
Interval 2.79 to
Due to small number of events, estimate (upper limit of 95% confidence interval) from Kaplan-Meier survival curves could not derive.
|
NA Months
Interval 6.93 to
Due to small number of events, estimates (median and upper limit of 95% confidence interval) from Kaplan-Meier survival curves could not derive.
|
21.13 Months
Interval 11.07 to
Due to small number of events, estimate (upper limit of 95% confidence interval) from Kaplan-Meier survival curves could not derive.
|
NA Months
Median, lower and upper limit of confidence interval could not be calculated because no participant had an event.
|
8.31 Months
Interval 6.6 to 22.67
|
4.14 Months
Interval 2.83 to 8.34
|
22.23 Months
Interval 4.04 to
Due to small number of events, estimate (upper limit of 95% confidence interval) from Kaplan-Meier survival curves could not derive.
|
—
|
—
|
NA Months
Median, lower and upper limit of confidence interval could not be calculated because no participant had an event.
|
NA Months
Interval 2.63 to
Due to small number of events, estimates (median and upper limit of 95% confidence interval) from Kaplan-Meier survival curves could not derive.
|
15.21 Months
Interval 11.07 to
Due to small number of events, estimate (upper limit of 95% confidence interval) from Kaplan-Meier survival curves could not derive.
|
NA Months
As per planned analysis, data was analyzed in form of graph and no descriptive analysis was performed.
|
NA Months
Interval 4.24 to
Due to small number of events, estimates (median and upper limit of 95% confidence interval) from Kaplan-Meier survival curves could not derive.
|
NA Months
Median, lower and upper limit of confidence interval could not be calculated because no participant had an event.
|
NA Months
As per planned analysis, data was analyzed in form of graph and no descriptive analysis was performed.
|
NA Months
Interval 2.79 to
Due to small number of events, estimates (median and upper limit of 95% confidence interval) from Kaplan-Meier survival curves could not derive.
|
NA Months
Interval 12.45 to
Due to small number of events, estimates (median and upper limit of 95% confidence interval) from Kaplan-Meier survival curves could not derive.
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Efficacy Expansion: Baseline up to Day 1072Population: FAS included all participants who have received at least 1 dose of study treatment. Here "Overall number of participants analyzed" signifies those who were evaluable for this outcome measure. This outcome measure was planned to be analyzed in Efficacy expansion cohorts only.
Duration of response according to modified irRC, per investigator assessment was calculated for each participant with a confirmed response (immune-related complete response \[irCR\] or immune-related partial response \[irPR\]) as the time from the first observation of response to the first observation of documented disease progression (or death within 12 weeks of the last tumor assessment). irCR: Complete disappearance of all tumor lesions (both index and non-index lesions with no new measurable/unmeasurable lesions). irPR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions). Results were calculated based on Kaplan-Meier estimates.
Outcome measures
| Measure |
Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)
Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)
Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 1.0 mg/kg
n=4 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 1.0 milligrams per kilogram (mg/kg) once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or investigational medicinal product (IMP) occurs.
|
Dose Escalation Cohort: Avelumab 3.0 mg/kg
n=32 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 3.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 10.0 mg/kg
n=7 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 20.0 mg/kg
n=14 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 20.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 10.0 mg/kg Weekly
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once weekly for the first 12 weeks and once every 2 weeks starting Week 13 in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: NSCLC, Post-platinum Doublet
Participants with non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: NSCLC, First Line
Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: Metastatic Breast Cancer
Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: GC/GEJC Progressed
Participants with gastric and gastroesophageal cancer who progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: GC/GEJC Non Progressed
Participants with gastric and gastroesophageal cancer who non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Colorectal Cancer
Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Castrate-resistant Prostate Cancer
Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Mesothelioma
Participants with mesothelioma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Urothelial Carcinoma
Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Ovarian Cancer
Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)
Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)
Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: Ovarian Cancer
Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: Urothelial Carcinoma
Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: GC/GEJC, Third Line
Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: HNSCC
Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Efficacy Expansion Cohorts: Duration of Response According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Per Independent Endpoint Review Committee (IERC)
|
—
|
—
|
NA Months
Median, lower and upper limit of confidence interval could not be calculated because no participant had an event.
|
NA Months
Interval 9.0 to
Due to small number of events, estimates (Median and upper limit of 95%confidence interval) from Kaplan-Meier survival curves could not be derived.
|
NA Months
Interval 4.24 to
Due to small number of events, estimates (Median and upper limit of 95%confidence interval) from Kaplan-Meier survival curves could not be derived.
|
NA Months
Interval 4.17 to
Due to small number of events, estimates (Median and upper limit of 95%confidence interval) from Kaplan-Meier survival curves could not be derived.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Efficacy Expansion: Baseline up to Day 1072Population: FAS included all participants who have received at least 1 dose of study treatment. Here "Overall number of participants analyzed" signifies those who were evaluable for this outcome measure. This outcome measure was planned to be analyzed in Efficacy expansion cohorts only.
The PFS time (based on IERC), according to the RECIST 1.1, was defined as the time from first administration of study treatment until first documentation of progressive disease (PD) or death when death occurred within 12 weeks of the last tumor assessment or first administration of study treatment (whichever was later). PD was defined as at least a 20% increase in the sum of longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions and unequivocal progression of non-target lesions. The analysis of PFS was performed with a Kaplan-Meier method.
Outcome measures
| Measure |
Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)
Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)
Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 1.0 mg/kg
n=103 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 1.0 milligrams per kilogram (mg/kg) once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or investigational medicinal product (IMP) occurs.
|
Dose Escalation Cohort: Avelumab 3.0 mg/kg
n=198 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 3.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 10.0 mg/kg
n=132 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 20.0 mg/kg
n=153 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 20.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 10.0 mg/kg Weekly
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once weekly for the first 12 weeks and once every 2 weeks starting Week 13 in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: NSCLC, Post-platinum Doublet
Participants with non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: NSCLC, First Line
Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: Metastatic Breast Cancer
Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: GC/GEJC Progressed
Participants with gastric and gastroesophageal cancer who progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: GC/GEJC Non Progressed
Participants with gastric and gastroesophageal cancer who non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Colorectal Cancer
Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Castrate-resistant Prostate Cancer
Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Mesothelioma
Participants with mesothelioma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Urothelial Carcinoma
Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Ovarian Cancer
Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)
Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)
Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: Ovarian Cancer
Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: Urothelial Carcinoma
Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: GC/GEJC, Third Line
Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: HNSCC
Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Efficacy Expansion Cohorts: Progression-Free Survival (PFS) Time According to Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1 as Per Independent Endpoint Review Committee (IERC)
|
—
|
—
|
1.87 Months
Interval 1.41 to 2.66
|
1.45 Months
Interval 1.38 to 2.56
|
1.31 Months
Interval 1.28 to 1.38
|
1.41 Months
Interval 1.38 to 2.63
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Dose Escalation: Baseline up to Day 1023Population: Safety analysis set included all participants who have received at least 1 dose of study treatment. Here "Overall number of participants analyzed" signifies those who were evaluable for this outcome measure.
Serum samples were analyzed by a validated electrochemiluminescence immunoassay to detect the presence of antidrug antibodies (ADA). Number of participants with ADA positive results for Avelumab were reported.
Outcome measures
| Measure |
Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)
Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)
Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 1.0 mg/kg
n=3 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 1.0 milligrams per kilogram (mg/kg) once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or investigational medicinal product (IMP) occurs.
|
Dose Escalation Cohort: Avelumab 3.0 mg/kg
n=13 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 3.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 10.0 mg/kg
n=9 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 20.0 mg/kg
n=20 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 20.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 10.0 mg/kg Weekly
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once weekly for the first 12 weeks and once every 2 weeks starting Week 13 in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: NSCLC, Post-platinum Doublet
Participants with non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: NSCLC, First Line
Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: Metastatic Breast Cancer
Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: GC/GEJC Progressed
Participants with gastric and gastroesophageal cancer who progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: GC/GEJC Non Progressed
Participants with gastric and gastroesophageal cancer who non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Colorectal Cancer
Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Castrate-resistant Prostate Cancer
Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Mesothelioma
Participants with mesothelioma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Urothelial Carcinoma
Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Ovarian Cancer
Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)
Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)
Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: Ovarian Cancer
Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: Urothelial Carcinoma
Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: GC/GEJC, Third Line
Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: HNSCC
Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Number of Participants With at Least 1 Positive Anti Drug Antibodies (ADA)
|
—
|
—
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Dose Expansion: Baseline up to Day 2023Population: Safety analysis set included all participants who have received at least 1 dose of study treatment. Here "Overall number of participants analyzed" signifies those who were evaluable for this outcome measure.
Serum samples were analyzed by a validated electrochemiluminescence immunoassay to detect the presence of antidrug antibodies (ADA). Number of participants with ADA positive results for Avelumab were reported.
Outcome measures
| Measure |
Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)
n=61 Participants
Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)
n=20 Participants
Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 1.0 mg/kg
n=184 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 1.0 milligrams per kilogram (mg/kg) once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or investigational medicinal product (IMP) occurs.
|
Dose Escalation Cohort: Avelumab 3.0 mg/kg
n=155 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 3.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 10.0 mg/kg
n=168 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 20.0 mg/kg
n=60 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 20.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 10.0 mg/kg Weekly
n=90 Participants
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once weekly for the first 12 weeks and once every 2 weeks starting Week 13 in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: NSCLC, Post-platinum Doublet
n=21 Participants
Participants with non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: NSCLC, First Line
n=18 Participants
Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: Metastatic Breast Cancer
n=50 Participants
Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: GC/GEJC Progressed
n=51 Participants
Participants with gastric and gastroesophageal cancer who progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: GC/GEJC Non Progressed
n=53 Participants
Participants with gastric and gastroesophageal cancer who non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Colorectal Cancer
n=43 Participants
Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Castrate-resistant Prostate Cancer
n=125 Participants
Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Mesothelioma
n=103 Participants
Participants with mesothelioma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Urothelial Carcinoma
n=201 Participants
Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Ovarian Cancer
n=130 Participants
Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)
n=151 Participants
Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)
Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: Ovarian Cancer
Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: Urothelial Carcinoma
Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: GC/GEJC, Third Line
Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: HNSCC
Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Expansion Cohort: Number of Participants With Atleast 1 Positive Anti Drug Antibodies (ADA) Assay
|
5 Participants
|
3 Participants
|
17 Participants
|
9 Participants
|
17 Participants
|
3 Participants
|
6 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
5 Participants
|
3 Participants
|
2 Participants
|
5 Participants
|
5 Participants
|
17 Participants
|
6 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Dose Escalation Cohort: Avelumab 1.0 mg/kg
Serious events: 3 serious events
Other events: 4 other events
Deaths: 4 deaths
Dose Escalation Cohort: Avelumab 3.0 mg/kg
Serious events: 6 serious events
Other events: 13 other events
Deaths: 11 deaths
Dose Escalation Cohort: Avelumab 10.0 mg/kg
Serious events: 6 serious events
Other events: 15 other events
Deaths: 11 deaths
Dose Escalation Cohort: Avelumab 20.0 mg/kg
Serious events: 8 serious events
Other events: 21 other events
Deaths: 16 deaths
Dose Escalation Cohort: Avelumab 10.0 mg/kg Weekly
Serious events: 0 serious events
Other events: 8 other events
Deaths: 2 deaths
Primary Expansion Cohort: NSCLC, Post-platinum Doublet
Serious events: 95 serious events
Other events: 178 other events
Deaths: 161 deaths
Primary Expansion Cohort: NSCLC, First Line
Serious events: 80 serious events
Other events: 152 other events
Deaths: 124 deaths
Primary Expansion Cohort: Metastatic Breast Cancer
Serious events: 66 serious events
Other events: 159 other events
Deaths: 141 deaths
Primary Expansion Cohort: GC/GEJC Progressed
Serious events: 36 serious events
Other events: 58 other events
Deaths: 50 deaths
Primary Expansion Cohort: GC/GEJC Non Progressed
Serious events: 44 serious events
Other events: 86 other events
Deaths: 75 deaths
Secondary Expansion Cohort: Colorectal Cancer
Serious events: 8 serious events
Other events: 20 other events
Deaths: 18 deaths
Secondary Expansion Cohort: Castrate-resistant Prostate Cancer
Serious events: 2 serious events
Other events: 17 other events
Deaths: 7 deaths
Secondary Expansion Cohort: Adrenocortical Carcinoma
Serious events: 32 serious events
Other events: 50 other events
Deaths: 27 deaths
Secondary Expansion Cohort: Melanoma
Serious events: 24 serious events
Other events: 50 other events
Deaths: 25 deaths
Secondary Expansion Cohort: Mesothelioma
Serious events: 22 serious events
Other events: 53 other events
Deaths: 34 deaths
Secondary Expansion Cohort: Urothelial Carcinoma
Serious events: 19 serious events
Other events: 44 other events
Deaths: 31 deaths
Secondary Expansion Cohort: Ovarian Cancer
Serious events: 42 serious events
Other events: 122 other events
Deaths: 87 deaths
Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)
Serious events: 14 serious events
Other events: 62 other events
Deaths: 17 deaths
Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)
Serious events: 7 serious events
Other events: 19 other events
Deaths: 14 deaths
Efficacy Expansion Cohort: Ovarian Cancer
Serious events: 48 serious events
Other events: 102 other events
Deaths: 71 deaths
Efficacy Expansion Cohort: Urothelial Carcinoma
Serious events: 114 serious events
Other events: 202 other events
Deaths: 129 deaths
Efficacy Expansion Cohort: GC/GEJC, Third Line
Serious events: 87 serious events
Other events: 125 other events
Deaths: 118 deaths
Efficacy Expansion Cohort: HNSCC
Serious events: 73 serious events
Other events: 143 other events
Deaths: 129 deaths
Serious adverse events
| Measure |
Dose Escalation Cohort: Avelumab 1.0 mg/kg
n=4 participants at risk
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 1.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 3.0 mg/kg
n=13 participants at risk
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 3.0 milligrams per kilogram (mg/kg) once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or investigational medicinal product (IMP) occurs.
|
Dose Escalation Cohort: Avelumab 10.0 mg/kg
n=15 participants at risk
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 20.0 mg/kg
n=21 participants at risk
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 20.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 10.0 mg/kg Weekly
n=8 participants at risk
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once weekly for the first 12 weeks and once every 2 weeks starting Week 13 in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: NSCLC, Post-platinum Doublet
n=184 participants at risk
Participants with non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: NSCLC, First Line
n=156 participants at risk
Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: Metastatic Breast Cancer
n=168 participants at risk
Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: GC/GEJC Progressed
n=60 participants at risk
Participants with gastric and gastroesophageal cancer who progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: GC/GEJC Non Progressed
n=90 participants at risk
Participants with gastric and gastroesophageal cancer who non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Colorectal Cancer
n=21 participants at risk
Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Castrate-resistant Prostate Cancer
n=18 participants at risk
Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Adrenocortical Carcinoma
n=50 participants at risk
Participants with adrenocortical carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Melanoma
n=51 participants at risk
Participants with melanoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Mesothelioma
n=53 participants at risk
Participants with mesothelioma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Urothelial Carcinoma
n=44 participants at risk
Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Ovarian Cancer
n=125 participants at risk
Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)
n=62 participants at risk
Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)
n=20 participants at risk
Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: Ovarian Cancer
n=103 participants at risk
Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: Urothelial Carcinoma
n=205 participants at risk
Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: GC/GEJC, Third Line
n=132 participants at risk
Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: HNSCC
n=153 participants at risk
Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Renal and urinary disorders
Renal ischaemia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Duodenal obstruction
|
25.0%
1/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Tongue haemorrhage
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Tongue oedema
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
General disorders
Oedema peripheral
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
1.6%
2/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
General disorders
Generalised oedema
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
General disorders
Localised oedema
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
General disorders
Hyperthermia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
General disorders
Complication associated with device
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea at rest
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal haemorrhage
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal haemorrhage
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Vascular disorders
Flushing
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Vascular disorders
Phlebitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Vascular disorders
Intermittent claudication
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Gallbladder abscess
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Urinary tract infection enterococcal
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Infections and infestations
Cystitis klebsiella
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Klebsiella bacteraemia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Infections and infestations
Psoas abscess
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Sepsis syndrome
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Urinary tract infection fungal
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
1.5%
2/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Abscess
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
H1N1 influenza
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Peritonitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Systemic infection
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
1.5%
3/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Renal and urinary disorders
Haemorrhage urinary tract
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Blood and lymphatic system disorders
Thrombotic microangiopathy
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
9.5%
2/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Gastroenteritis radiation
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Incorrect dose administered
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Tracheal obstruction
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
1.5%
2/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Partial seizures
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Neurotoxicity
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to ovary
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant ascites
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to peritoneum
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic gastric cancer
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
2.6%
4/153 • Baseline up to Day 2511
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tonsil cancer
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Psychiatric disorders
Mood altered
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Psychiatric disorders
Delirium
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Blood creatine increased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
C-reactive protein increased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Coma
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Endocrine disorders
Thyroiditis acute
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Product Issues
Device dislocation
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Product Issues
Device malfunction
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Reproductive system and breast disorders
Vaginal fistula
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Eye disorders
Vision blurred
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Eye disorders
Visual impairment
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Eye disorders
Eye pain
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
General disorders
Disease progression
|
0.00%
0/4 • Baseline up to Day 2511
|
30.8%
4/13 • Baseline up to Day 2511
|
13.3%
2/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
12.5%
23/184 • Baseline up to Day 2511
|
10.3%
16/156 • Baseline up to Day 2511
|
8.3%
14/168 • Baseline up to Day 2511
|
13.3%
8/60 • Baseline up to Day 2511
|
11.1%
10/90 • Baseline up to Day 2511
|
14.3%
3/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
12.0%
6/50 • Baseline up to Day 2511
|
5.9%
3/51 • Baseline up to Day 2511
|
5.7%
3/53 • Baseline up to Day 2511
|
18.2%
8/44 • Baseline up to Day 2511
|
10.4%
13/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
10.0%
2/20 • Baseline up to Day 2511
|
8.7%
9/103 • Baseline up to Day 2511
|
16.6%
34/205 • Baseline up to Day 2511
|
23.5%
31/132 • Baseline up to Day 2511
|
11.8%
18/153 • Baseline up to Day 2511
|
|
General disorders
Fatigue
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
6.7%
1/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
3.3%
2/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
General disorders
Influenza like illness
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
6.7%
1/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Pneumonia
|
25.0%
1/4 • Baseline up to Day 2511
|
7.7%
1/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
6.5%
12/184 • Baseline up to Day 2511
|
9.0%
14/156 • Baseline up to Day 2511
|
1.2%
2/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
1.6%
2/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
2.0%
4/205 • Baseline up to Day 2511
|
3.0%
4/132 • Baseline up to Day 2511
|
2.0%
3/153 • Baseline up to Day 2511
|
|
Infections and infestations
Kidney infection
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Peritonitis bacterial
|
25.0%
1/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
1.5%
2/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
1.9%
3/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
4.5%
2/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
1.9%
2/103 • Baseline up to Day 2511
|
3.4%
7/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/4 • Baseline up to Day 2511
|
7.7%
1/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
4.9%
9/184 • Baseline up to Day 2511
|
3.2%
5/156 • Baseline up to Day 2511
|
4.8%
8/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
2.2%
2/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
7.5%
4/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
1.6%
2/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
10.0%
2/20 • Baseline up to Day 2511
|
2.9%
3/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
2.3%
3/132 • Baseline up to Day 2511
|
2.6%
4/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
25.0%
1/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
1.9%
3/156 • Baseline up to Day 2511
|
1.2%
2/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
1.3%
2/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.6%
3/184 • Baseline up to Day 2511
|
1.3%
2/156 • Baseline up to Day 2511
|
6.0%
10/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
4.0%
2/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
3.2%
4/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
10.0%
2/20 • Baseline up to Day 2511
|
5.8%
6/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
2.3%
3/132 • Baseline up to Day 2511
|
2.0%
3/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.6%
3/184 • Baseline up to Day 2511
|
3.8%
6/156 • Baseline up to Day 2511
|
1.8%
3/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
2.9%
3/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
2.3%
3/132 • Baseline up to Day 2511
|
1.3%
2/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
6.7%
1/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
1.2%
2/168 • Baseline up to Day 2511
|
10.0%
6/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
8.0%
4/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
2.4%
3/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
5.8%
6/103 • Baseline up to Day 2511
|
2.4%
5/205 • Baseline up to Day 2511
|
6.1%
8/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
6.7%
1/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Ascites
|
25.0%
1/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
5.0%
3/60 • Baseline up to Day 2511
|
3.3%
3/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
2.4%
3/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
2.9%
3/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
3.0%
4/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
6.7%
1/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
3.2%
4/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
2.3%
3/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/4 • Baseline up to Day 2511
|
7.7%
1/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Immune system disorders
Autoimmune disorder
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
13.3%
2/15 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Blood alkaline phosphatase increased
|
25.0%
1/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Alanine aminotransferase increased
|
25.0%
1/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Amylase increased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Aspartate aminotransferase increased
|
25.0%
1/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
6.7%
1/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
1.5%
2/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
6.7%
1/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
4.0%
2/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/4 • Baseline up to Day 2511
|
7.7%
1/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
1.3%
2/156 • Baseline up to Day 2511
|
1.2%
2/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
2.3%
3/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Vascular disorders
Embolism
|
0.00%
0/4 • Baseline up to Day 2511
|
7.7%
1/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
3.8%
2/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
1.5%
2/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Vascular disorders
Haematoma
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
3.3%
2/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
1.9%
2/103 • Baseline up to Day 2511
|
1.5%
3/205 • Baseline up to Day 2511
|
2.3%
3/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
6.7%
1/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
3.8%
7/184 • Baseline up to Day 2511
|
2.6%
4/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.6%
3/184 • Baseline up to Day 2511
|
1.9%
3/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
3.8%
2/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.6%
3/184 • Baseline up to Day 2511
|
1.3%
2/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
2.0%
3/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
1.2%
2/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
1.3%
2/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
1.3%
2/156 • Baseline up to Day 2511
|
1.2%
2/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
3.8%
2/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
1.5%
3/205 • Baseline up to Day 2511
|
1.5%
2/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
1.9%
3/156 • Baseline up to Day 2511
|
1.2%
2/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
3.3%
2/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
4.0%
2/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
4.5%
2/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Chylothorax
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
2.2%
2/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
1.5%
2/132 • Baseline up to Day 2511
|
3.3%
5/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory acidosis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
2.4%
4/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
5.7%
3/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
General disorders
Pyrexia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
4.0%
2/50 • Baseline up to Day 2511
|
5.9%
3/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
2.0%
4/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
2.6%
4/153 • Baseline up to Day 2511
|
|
General disorders
Pain
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
General disorders
Asthenia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
1.9%
3/156 • Baseline up to Day 2511
|
1.8%
3/168 • Baseline up to Day 2511
|
3.3%
2/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
4.0%
2/50 • Baseline up to Day 2511
|
3.9%
2/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
1.5%
3/205 • Baseline up to Day 2511
|
1.5%
2/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
General disorders
Chest pain
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
General disorders
Death
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
General disorders
General physical health deterioration
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
1.5%
3/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
General disorders
Medical device site pain
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
General disorders
Oedema due to cardiac disease
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Pleural fistula
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary arterial hypertension
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
General disorders
Gait disturbance
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
General disorders
Chills
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Lethargy
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Sepsis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.6%
3/184 • Baseline up to Day 2511
|
1.3%
2/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
3.3%
2/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
4.0%
2/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
2.9%
3/103 • Baseline up to Day 2511
|
2.4%
5/205 • Baseline up to Day 2511
|
1.5%
2/132 • Baseline up to Day 2511
|
3.3%
5/153 • Baseline up to Day 2511
|
|
Infections and infestations
Bronchitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
1.9%
3/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Infections and infestations
Cystitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Septic shock
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Urosepsis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
2.4%
5/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Infections and infestations
Appendicitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Immune system disorders
Type I hypersensitivity
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Aspergillus infection
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Cellulitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
1.3%
2/153 • Baseline up to Day 2511
|
|
Infections and infestations
Lung infection
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
1.3%
2/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
4.0%
2/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
1.3%
2/153 • Baseline up to Day 2511
|
|
Infections and infestations
Pulmonary sepsis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Arteritis infective
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Hepatitis E
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Infected bite
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Paronychia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Peritonsillar abscess
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Infection
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
6.0%
3/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Viral infection
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
2.2%
4/184 • Baseline up to Day 2511
|
2.6%
4/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
2.0%
4/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Radiation necrosis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Radiation pneumonitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Gastrostomy tube site complication
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Subarachnoid haemorrhage
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Seizure
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Embolic stroke
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
1.3%
2/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Monoplegia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Serotonin syndrome
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Syncope
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
2.2%
2/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Thecal sac compression
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
1.3%
2/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
1.3%
2/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Vocal cord paralysis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Ataxia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Paraparesis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Brain injury
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
1.3%
2/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
3.3%
2/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
1.6%
2/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
3.9%
4/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
5.3%
7/132 • Baseline up to Day 2511
|
1.3%
2/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
1.3%
2/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
3.3%
2/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
6.0%
3/50 • Baseline up to Day 2511
|
3.9%
2/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
5.8%
6/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
5.3%
7/132 • Baseline up to Day 2511
|
1.3%
2/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Incarcerated inguinal hernia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Malignant gastrointestinal obstruction
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
3.3%
2/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
3.9%
2/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Ileal perforation
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Inflammatory bowel disease
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
2.2%
2/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
1.5%
2/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
2.2%
2/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
3.0%
4/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
3.3%
3/90 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
4.8%
6/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
4.9%
5/103 • Baseline up to Day 2511
|
2.0%
4/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
2.4%
3/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
1.9%
2/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
6.0%
3/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
1.9%
2/103 • Baseline up to Day 2511
|
2.0%
4/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
1.5%
2/132 • Baseline up to Day 2511
|
2.0%
3/153 • Baseline up to Day 2511
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.6%
3/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
1.2%
2/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
4.0%
2/50 • Baseline up to Day 2511
|
3.9%
2/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
1.2%
2/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
2.6%
4/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
1.5%
2/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Cardiac disorders
Intracardiac thrombus
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.6%
3/184 • Baseline up to Day 2511
|
1.3%
2/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
3.2%
2/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
1.5%
2/132 • Baseline up to Day 2511
|
1.3%
2/153 • Baseline up to Day 2511
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
8.0%
4/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
2.9%
3/103 • Baseline up to Day 2511
|
2.4%
5/205 • Baseline up to Day 2511
|
2.3%
3/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
1.5%
2/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
2.2%
2/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
2.4%
4/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
3.2%
2/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
2.0%
4/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
1.3%
2/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
1.3%
2/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
1.2%
2/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.6%
3/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
1.8%
3/168 • Baseline up to Day 2511
|
5.0%
3/60 • Baseline up to Day 2511
|
3.3%
3/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
1.5%
3/205 • Baseline up to Day 2511
|
1.5%
2/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Blood and lymphatic system disorders
Autoimmune neutropenia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.6%
3/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myeloid leukaemia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
1.3%
2/153 • Baseline up to Day 2511
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spine
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer metastatic
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
1.2%
2/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to peripheral nervous system
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
2.2%
2/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour invasion
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Vascular disorders
Jugular vein thrombosis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
1.3%
2/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
1.3%
2/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Vascular disorders
Subclavian vein thrombosis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Vascular disorders
Ischaemia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.6%
3/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
4.0%
2/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Endocrine disorders
Hypercalcaemia of malignancy
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Eye disorders
Ocular retrobulbar haemorrhage
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
8.0%
4/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
1.9%
2/103 • Baseline up to Day 2511
|
3.4%
7/205 • Baseline up to Day 2511
|
3.8%
5/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
3.4%
7/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
1.2%
2/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
2.2%
2/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Hepatobiliary disorders
Liver injury
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Hepatobiliary disorders
Hepatocellular injury
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Investigations
Electrocardiogram T wave abnormal
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Blood potassium increased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
False positive investigation result
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Weight decreased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Transaminases increased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
1.9%
2/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Lipase increased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Liver function test increased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
General disorders
Catheter site pain
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
5.6%
1/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Perirenal haematoma
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
4.0%
2/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
5.0%
3/60 • Baseline up to Day 2511
|
5.6%
5/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
2.0%
3/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
General physical condition abnormal
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Inflammatory marker increased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Posterior reversible encephalopathy syndrome
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Sensorimotor disorder
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Clostridial sepsis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Device related infection
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Spinal cord infection
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Perirectal abscess
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Renal and urinary disorders
Renal disorder
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
1.9%
2/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Renal and urinary disorders
Bladder spasm
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Wound infection
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
5.6%
1/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopneumopathy
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory depression
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Endocrine disorders
Adrenocortical insufficiency acute
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Endocrine disorders
Thyroiditis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Cardiac disorders
Cardiac failure chronic
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
4.0%
2/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Eye disorders
Retinopathy hypertensive
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Vascular disorders
Peripheral embolism
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastasis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
3.9%
2/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour compression
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Immune system disorders
Sarcoidosis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Peritoneal haemorrhage
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Oesophagitis ulcerative
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Abdominal wall haematoma
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Oesophageal haemorrhage
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Oesophageal pain
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Strangulated umbilical hernia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
Other adverse events
| Measure |
Dose Escalation Cohort: Avelumab 1.0 mg/kg
n=4 participants at risk
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 1.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 3.0 mg/kg
n=13 participants at risk
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 3.0 milligrams per kilogram (mg/kg) once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or investigational medicinal product (IMP) occurs.
|
Dose Escalation Cohort: Avelumab 10.0 mg/kg
n=15 participants at risk
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 20.0 mg/kg
n=21 participants at risk
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 20.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Dose Escalation Cohort: Avelumab 10.0 mg/kg Weekly
n=8 participants at risk
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once weekly for the first 12 weeks and once every 2 weeks starting Week 13 in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: NSCLC, Post-platinum Doublet
n=184 participants at risk
Participants with non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: NSCLC, First Line
n=156 participants at risk
Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: Metastatic Breast Cancer
n=168 participants at risk
Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: GC/GEJC Progressed
n=60 participants at risk
Participants with gastric and gastroesophageal cancer who progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Primary Expansion Cohort: GC/GEJC Non Progressed
n=90 participants at risk
Participants with gastric and gastroesophageal cancer who non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Colorectal Cancer
n=21 participants at risk
Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Castrate-resistant Prostate Cancer
n=18 participants at risk
Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Adrenocortical Carcinoma
n=50 participants at risk
Participants with adrenocortical carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Melanoma
n=51 participants at risk
Participants with melanoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Mesothelioma
n=53 participants at risk
Participants with mesothelioma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Urothelial Carcinoma
n=44 participants at risk
Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Ovarian Cancer
n=125 participants at risk
Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)
n=62 participants at risk
Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)
n=20 participants at risk
Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: Ovarian Cancer
n=103 participants at risk
Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: Urothelial Carcinoma
n=205 participants at risk
Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: GC/GEJC, Third Line
n=132 participants at risk
Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
Efficacy Expansion Cohort: HNSCC
n=153 participants at risk
Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Endocrine disorders
Hypercalcaemia of malignancy
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Ear and labyrinth disorders
Ear congestion
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
General disorders
Feeling jittery
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Eye disorders
Cataract nuclear
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Musculoskeletal and connective tissue disorders
Soft tissue swelling
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Vascular disorders
Flushing
|
0.00%
0/4 • Baseline up to Day 2511
|
7.7%
1/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.6%
3/184 • Baseline up to Day 2511
|
1.9%
3/156 • Baseline up to Day 2511
|
1.2%
2/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
1.5%
2/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Dyskinesia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
1.3%
2/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Human epidermal growth factor receptor decreased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Intestinal transit time abnormal
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Eye disorders
Chorioretinal scar
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
General disorders
Granuloma
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Vascular disorders
Vena cava thrombosis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
6.7%
1/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Investigations
Neutrophil count increased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Cardiac disorders
Acute left ventricular failure
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
1.3%
2/153 • Baseline up to Day 2511
|
|
Infections and infestations
Tinea versicolour
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Investigations
Nitrite urine present
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
3.2%
2/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
1.5%
3/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Abdominal mass
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract irritation
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Chylothorax
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Choking
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Increased viscosity of bronchial secretion
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal obstruction
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal pain
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
General disorders
Mucosal inflammation
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
12.5%
1/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
3.2%
2/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal erythema
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal oedema
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Erythema ab igne
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
General disorders
Fatigue
|
50.0%
2/4 • Baseline up to Day 2511
|
53.8%
7/13 • Baseline up to Day 2511
|
86.7%
13/15 • Baseline up to Day 2511
|
28.6%
6/21 • Baseline up to Day 2511
|
37.5%
3/8 • Baseline up to Day 2511
|
40.2%
74/184 • Baseline up to Day 2511
|
45.5%
71/156 • Baseline up to Day 2511
|
39.3%
66/168 • Baseline up to Day 2511
|
21.7%
13/60 • Baseline up to Day 2511
|
22.2%
20/90 • Baseline up to Day 2511
|
23.8%
5/21 • Baseline up to Day 2511
|
38.9%
7/18 • Baseline up to Day 2511
|
34.0%
17/50 • Baseline up to Day 2511
|
25.5%
13/51 • Baseline up to Day 2511
|
32.1%
17/53 • Baseline up to Day 2511
|
38.6%
17/44 • Baseline up to Day 2511
|
28.8%
36/125 • Baseline up to Day 2511
|
43.5%
27/62 • Baseline up to Day 2511
|
50.0%
10/20 • Baseline up to Day 2511
|
36.9%
38/103 • Baseline up to Day 2511
|
35.1%
72/205 • Baseline up to Day 2511
|
28.0%
37/132 • Baseline up to Day 2511
|
26.8%
41/153 • Baseline up to Day 2511
|
|
General disorders
Pyrexia
|
100.0%
4/4 • Baseline up to Day 2511
|
15.4%
2/13 • Baseline up to Day 2511
|
26.7%
4/15 • Baseline up to Day 2511
|
19.0%
4/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
10.3%
19/184 • Baseline up to Day 2511
|
12.8%
20/156 • Baseline up to Day 2511
|
11.9%
20/168 • Baseline up to Day 2511
|
11.7%
7/60 • Baseline up to Day 2511
|
6.7%
6/90 • Baseline up to Day 2511
|
19.0%
4/21 • Baseline up to Day 2511
|
11.1%
2/18 • Baseline up to Day 2511
|
30.0%
15/50 • Baseline up to Day 2511
|
9.8%
5/51 • Baseline up to Day 2511
|
15.1%
8/53 • Baseline up to Day 2511
|
13.6%
6/44 • Baseline up to Day 2511
|
8.0%
10/125 • Baseline up to Day 2511
|
16.1%
10/62 • Baseline up to Day 2511
|
10.0%
2/20 • Baseline up to Day 2511
|
15.5%
16/103 • Baseline up to Day 2511
|
16.1%
33/205 • Baseline up to Day 2511
|
15.9%
21/132 • Baseline up to Day 2511
|
20.3%
31/153 • Baseline up to Day 2511
|
|
General disorders
Influenza like illness
|
25.0%
1/4 • Baseline up to Day 2511
|
7.7%
1/13 • Baseline up to Day 2511
|
26.7%
4/15 • Baseline up to Day 2511
|
33.3%
7/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
4.9%
9/184 • Baseline up to Day 2511
|
3.2%
5/156 • Baseline up to Day 2511
|
8.3%
14/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
5.6%
5/90 • Baseline up to Day 2511
|
9.5%
2/21 • Baseline up to Day 2511
|
16.7%
3/18 • Baseline up to Day 2511
|
6.0%
3/50 • Baseline up to Day 2511
|
3.9%
2/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
4.5%
2/44 • Baseline up to Day 2511
|
6.4%
8/125 • Baseline up to Day 2511
|
6.5%
4/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
4.9%
5/103 • Baseline up to Day 2511
|
2.9%
6/205 • Baseline up to Day 2511
|
2.3%
3/132 • Baseline up to Day 2511
|
3.9%
6/153 • Baseline up to Day 2511
|
|
General disorders
Chills
|
25.0%
1/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
13.3%
2/15 • Baseline up to Day 2511
|
9.5%
2/21 • Baseline up to Day 2511
|
12.5%
1/8 • Baseline up to Day 2511
|
12.0%
22/184 • Baseline up to Day 2511
|
9.6%
15/156 • Baseline up to Day 2511
|
4.8%
8/168 • Baseline up to Day 2511
|
5.0%
3/60 • Baseline up to Day 2511
|
6.7%
6/90 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
11.1%
2/18 • Baseline up to Day 2511
|
14.0%
7/50 • Baseline up to Day 2511
|
17.6%
9/51 • Baseline up to Day 2511
|
20.8%
11/53 • Baseline up to Day 2511
|
13.6%
6/44 • Baseline up to Day 2511
|
8.8%
11/125 • Baseline up to Day 2511
|
14.5%
9/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
15.5%
16/103 • Baseline up to Day 2511
|
8.8%
18/205 • Baseline up to Day 2511
|
11.4%
15/132 • Baseline up to Day 2511
|
9.2%
14/153 • Baseline up to Day 2511
|
|
General disorders
Oedema peripheral
|
25.0%
1/4 • Baseline up to Day 2511
|
15.4%
2/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
12.5%
1/8 • Baseline up to Day 2511
|
14.1%
26/184 • Baseline up to Day 2511
|
17.3%
27/156 • Baseline up to Day 2511
|
10.1%
17/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
2.2%
2/90 • Baseline up to Day 2511
|
9.5%
2/21 • Baseline up to Day 2511
|
5.6%
1/18 • Baseline up to Day 2511
|
22.0%
11/50 • Baseline up to Day 2511
|
13.7%
7/51 • Baseline up to Day 2511
|
13.2%
7/53 • Baseline up to Day 2511
|
15.9%
7/44 • Baseline up to Day 2511
|
20.0%
25/125 • Baseline up to Day 2511
|
9.7%
6/62 • Baseline up to Day 2511
|
10.0%
2/20 • Baseline up to Day 2511
|
20.4%
21/103 • Baseline up to Day 2511
|
15.1%
31/205 • Baseline up to Day 2511
|
15.9%
21/132 • Baseline up to Day 2511
|
4.6%
7/153 • Baseline up to Day 2511
|
|
General disorders
Malaise
|
25.0%
1/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
3.3%
6/184 • Baseline up to Day 2511
|
4.5%
7/156 • Baseline up to Day 2511
|
1.2%
2/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
5.6%
1/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
3.9%
2/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
4.5%
2/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
1.5%
3/205 • Baseline up to Day 2511
|
1.5%
2/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
General disorders
Peripheral swelling
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
25.0%
2/8 • Baseline up to Day 2511
|
1.6%
3/184 • Baseline up to Day 2511
|
1.9%
3/156 • Baseline up to Day 2511
|
3.6%
6/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
6.8%
3/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
3.9%
4/103 • Baseline up to Day 2511
|
2.0%
4/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
General disorders
Asthenia
|
25.0%
1/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
6.0%
11/184 • Baseline up to Day 2511
|
8.3%
13/156 • Baseline up to Day 2511
|
8.9%
15/168 • Baseline up to Day 2511
|
8.3%
5/60 • Baseline up to Day 2511
|
8.9%
8/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
14.0%
7/50 • Baseline up to Day 2511
|
13.7%
7/51 • Baseline up to Day 2511
|
17.0%
9/53 • Baseline up to Day 2511
|
18.2%
8/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
19.4%
12/62 • Baseline up to Day 2511
|
10.0%
2/20 • Baseline up to Day 2511
|
5.8%
6/103 • Baseline up to Day 2511
|
12.2%
25/205 • Baseline up to Day 2511
|
8.3%
11/132 • Baseline up to Day 2511
|
12.4%
19/153 • Baseline up to Day 2511
|
|
General disorders
Chest pain
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
12.5%
1/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
1.9%
3/156 • Baseline up to Day 2511
|
4.2%
7/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
3.8%
2/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
10.0%
2/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
2.0%
4/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
General disorders
Facial pain
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
6.7%
1/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
2.6%
4/153 • Baseline up to Day 2511
|
|
General disorders
Injection site reaction
|
0.00%
0/4 • Baseline up to Day 2511
|
7.7%
1/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
12.5%
1/8 • Baseline up to Day 2511
|
8.2%
15/184 • Baseline up to Day 2511
|
7.7%
12/156 • Baseline up to Day 2511
|
5.4%
9/168 • Baseline up to Day 2511
|
3.3%
2/60 • Baseline up to Day 2511
|
5.6%
5/90 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
10.0%
5/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
9.4%
5/53 • Baseline up to Day 2511
|
4.5%
2/44 • Baseline up to Day 2511
|
4.0%
5/125 • Baseline up to Day 2511
|
6.5%
4/62 • Baseline up to Day 2511
|
10.0%
2/20 • Baseline up to Day 2511
|
8.7%
9/103 • Baseline up to Day 2511
|
2.0%
4/205 • Baseline up to Day 2511
|
4.5%
6/132 • Baseline up to Day 2511
|
3.3%
5/153 • Baseline up to Day 2511
|
|
Investigations
Aspartate aminotransferase increased
|
50.0%
2/4 • Baseline up to Day 2511
|
15.4%
2/13 • Baseline up to Day 2511
|
6.7%
1/15 • Baseline up to Day 2511
|
23.8%
5/21 • Baseline up to Day 2511
|
12.5%
1/8 • Baseline up to Day 2511
|
2.2%
4/184 • Baseline up to Day 2511
|
2.6%
4/156 • Baseline up to Day 2511
|
8.3%
14/168 • Baseline up to Day 2511
|
5.0%
3/60 • Baseline up to Day 2511
|
11.1%
10/90 • Baseline up to Day 2511
|
23.8%
5/21 • Baseline up to Day 2511
|
11.1%
2/18 • Baseline up to Day 2511
|
14.0%
7/50 • Baseline up to Day 2511
|
5.9%
3/51 • Baseline up to Day 2511
|
5.7%
3/53 • Baseline up to Day 2511
|
9.1%
4/44 • Baseline up to Day 2511
|
4.0%
5/125 • Baseline up to Day 2511
|
4.8%
3/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
2.9%
3/103 • Baseline up to Day 2511
|
7.3%
15/205 • Baseline up to Day 2511
|
14.4%
19/132 • Baseline up to Day 2511
|
3.3%
5/153 • Baseline up to Day 2511
|
|
Investigations
Weight decreased
|
25.0%
1/4 • Baseline up to Day 2511
|
7.7%
1/13 • Baseline up to Day 2511
|
33.3%
5/15 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
14.7%
27/184 • Baseline up to Day 2511
|
28.8%
45/156 • Baseline up to Day 2511
|
7.7%
13/168 • Baseline up to Day 2511
|
35.0%
21/60 • Baseline up to Day 2511
|
21.1%
19/90 • Baseline up to Day 2511
|
14.3%
3/21 • Baseline up to Day 2511
|
5.6%
1/18 • Baseline up to Day 2511
|
18.0%
9/50 • Baseline up to Day 2511
|
15.7%
8/51 • Baseline up to Day 2511
|
18.9%
10/53 • Baseline up to Day 2511
|
34.1%
15/44 • Baseline up to Day 2511
|
17.6%
22/125 • Baseline up to Day 2511
|
4.8%
3/62 • Baseline up to Day 2511
|
15.0%
3/20 • Baseline up to Day 2511
|
17.5%
18/103 • Baseline up to Day 2511
|
17.6%
36/205 • Baseline up to Day 2511
|
16.7%
22/132 • Baseline up to Day 2511
|
22.2%
34/153 • Baseline up to Day 2511
|
|
Investigations
Weight increased
|
0.00%
0/4 • Baseline up to Day 2511
|
23.1%
3/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
14.3%
3/21 • Baseline up to Day 2511
|
12.5%
1/8 • Baseline up to Day 2511
|
7.1%
13/184 • Baseline up to Day 2511
|
5.8%
9/156 • Baseline up to Day 2511
|
1.2%
2/168 • Baseline up to Day 2511
|
3.3%
2/60 • Baseline up to Day 2511
|
4.4%
4/90 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
5.6%
1/18 • Baseline up to Day 2511
|
16.0%
8/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
3.8%
2/53 • Baseline up to Day 2511
|
15.9%
7/44 • Baseline up to Day 2511
|
8.8%
11/125 • Baseline up to Day 2511
|
3.2%
2/62 • Baseline up to Day 2511
|
10.0%
2/20 • Baseline up to Day 2511
|
7.8%
8/103 • Baseline up to Day 2511
|
3.9%
8/205 • Baseline up to Day 2511
|
2.3%
3/132 • Baseline up to Day 2511
|
1.3%
2/153 • Baseline up to Day 2511
|
|
Investigations
White blood cell count decreased
|
25.0%
1/4 • Baseline up to Day 2511
|
15.4%
2/13 • Baseline up to Day 2511
|
20.0%
3/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
9.5%
2/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
1.6%
2/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
1.3%
2/153 • Baseline up to Day 2511
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
6.7%
1/15 • Baseline up to Day 2511
|
14.3%
3/21 • Baseline up to Day 2511
|
12.5%
1/8 • Baseline up to Day 2511
|
1.6%
3/184 • Baseline up to Day 2511
|
4.5%
7/156 • Baseline up to Day 2511
|
6.5%
11/168 • Baseline up to Day 2511
|
3.3%
2/60 • Baseline up to Day 2511
|
7.8%
7/90 • Baseline up to Day 2511
|
19.0%
4/21 • Baseline up to Day 2511
|
11.1%
2/18 • Baseline up to Day 2511
|
18.0%
9/50 • Baseline up to Day 2511
|
3.9%
2/51 • Baseline up to Day 2511
|
3.8%
2/53 • Baseline up to Day 2511
|
4.5%
2/44 • Baseline up to Day 2511
|
3.2%
4/125 • Baseline up to Day 2511
|
3.2%
2/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
2.9%
3/103 • Baseline up to Day 2511
|
3.9%
8/205 • Baseline up to Day 2511
|
7.6%
10/132 • Baseline up to Day 2511
|
3.3%
5/153 • Baseline up to Day 2511
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/4 • Baseline up to Day 2511
|
7.7%
1/13 • Baseline up to Day 2511
|
6.7%
1/15 • Baseline up to Day 2511
|
9.5%
2/21 • Baseline up to Day 2511
|
12.5%
1/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
1.9%
3/156 • Baseline up to Day 2511
|
4.2%
7/168 • Baseline up to Day 2511
|
6.7%
4/60 • Baseline up to Day 2511
|
3.3%
3/90 • Baseline up to Day 2511
|
33.3%
7/21 • Baseline up to Day 2511
|
5.6%
1/18 • Baseline up to Day 2511
|
10.0%
5/50 • Baseline up to Day 2511
|
3.9%
2/51 • Baseline up to Day 2511
|
3.8%
2/53 • Baseline up to Day 2511
|
4.5%
2/44 • Baseline up to Day 2511
|
2.4%
3/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
10.0%
2/20 • Baseline up to Day 2511
|
2.9%
3/103 • Baseline up to Day 2511
|
6.8%
14/205 • Baseline up to Day 2511
|
8.3%
11/132 • Baseline up to Day 2511
|
2.0%
3/153 • Baseline up to Day 2511
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
6.7%
1/15 • Baseline up to Day 2511
|
14.3%
3/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
2.2%
4/184 • Baseline up to Day 2511
|
2.6%
4/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
4.4%
4/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
4.5%
2/44 • Baseline up to Day 2511
|
2.4%
3/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Blood creatinine increased
|
50.0%
2/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
9.5%
2/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
3.8%
7/184 • Baseline up to Day 2511
|
7.1%
11/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
11.1%
2/18 • Baseline up to Day 2511
|
14.0%
7/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
7.5%
4/53 • Baseline up to Day 2511
|
9.1%
4/44 • Baseline up to Day 2511
|
2.4%
3/125 • Baseline up to Day 2511
|
11.3%
7/62 • Baseline up to Day 2511
|
10.0%
2/20 • Baseline up to Day 2511
|
9.7%
10/103 • Baseline up to Day 2511
|
10.7%
22/205 • Baseline up to Day 2511
|
4.5%
6/132 • Baseline up to Day 2511
|
1.3%
2/153 • Baseline up to Day 2511
|
|
Investigations
Lipase increased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
19.0%
4/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
2.7%
5/184 • Baseline up to Day 2511
|
5.1%
8/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
3.3%
2/60 • Baseline up to Day 2511
|
2.2%
2/90 • Baseline up to Day 2511
|
14.3%
3/21 • Baseline up to Day 2511
|
5.6%
1/18 • Baseline up to Day 2511
|
8.0%
4/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
3.2%
4/125 • Baseline up to Day 2511
|
12.9%
8/62 • Baseline up to Day 2511
|
15.0%
3/20 • Baseline up to Day 2511
|
1.9%
2/103 • Baseline up to Day 2511
|
2.9%
6/205 • Baseline up to Day 2511
|
1.5%
2/132 • Baseline up to Day 2511
|
1.3%
2/153 • Baseline up to Day 2511
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/4 • Baseline up to Day 2511
|
15.4%
2/13 • Baseline up to Day 2511
|
13.3%
2/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
3.6%
6/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
33.3%
7/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
10.0%
5/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
13.2%
7/53 • Baseline up to Day 2511
|
6.8%
3/44 • Baseline up to Day 2511
|
2.4%
3/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
4.9%
5/103 • Baseline up to Day 2511
|
1.5%
3/205 • Baseline up to Day 2511
|
3.0%
4/132 • Baseline up to Day 2511
|
4.6%
7/153 • Baseline up to Day 2511
|
|
Investigations
Amylase increased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
9.5%
2/21 • Baseline up to Day 2511
|
12.5%
1/8 • Baseline up to Day 2511
|
2.7%
5/184 • Baseline up to Day 2511
|
3.8%
6/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
2.2%
2/90 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
11.1%
2/18 • Baseline up to Day 2511
|
4.0%
2/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
2.4%
3/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
10.0%
2/20 • Baseline up to Day 2511
|
2.9%
3/103 • Baseline up to Day 2511
|
2.9%
6/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Gamma-glutamyltransferase increased
|
25.0%
1/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
6.7%
1/15 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
2.2%
4/184 • Baseline up to Day 2511
|
3.2%
5/156 • Baseline up to Day 2511
|
3.6%
6/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
4.4%
4/90 • Baseline up to Day 2511
|
14.3%
3/21 • Baseline up to Day 2511
|
5.6%
1/18 • Baseline up to Day 2511
|
8.0%
4/50 • Baseline up to Day 2511
|
3.9%
2/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
11.4%
5/44 • Baseline up to Day 2511
|
3.2%
4/125 • Baseline up to Day 2511
|
4.8%
3/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
2.9%
6/205 • Baseline up to Day 2511
|
3.8%
5/132 • Baseline up to Day 2511
|
1.3%
2/153 • Baseline up to Day 2511
|
|
Investigations
Platelet count decreased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
20.0%
3/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
1.2%
2/168 • Baseline up to Day 2511
|
3.3%
2/60 • Baseline up to Day 2511
|
2.2%
2/90 • Baseline up to Day 2511
|
14.3%
3/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
4.0%
2/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
4.5%
2/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
2.0%
4/205 • Baseline up to Day 2511
|
3.0%
4/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/4 • Baseline up to Day 2511
|
7.7%
1/13 • Baseline up to Day 2511
|
6.7%
1/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/4 • Baseline up to Day 2511
|
7.7%
1/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
2.2%
4/184 • Baseline up to Day 2511
|
2.6%
4/156 • Baseline up to Day 2511
|
1.8%
3/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
9.5%
2/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
3.9%
2/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
2.9%
3/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
2.3%
3/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Investigations
Blood bilirubin increased
|
25.0%
1/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
1.3%
2/156 • Baseline up to Day 2511
|
1.8%
3/168 • Baseline up to Day 2511
|
5.0%
3/60 • Baseline up to Day 2511
|
4.4%
4/90 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
5.6%
1/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
1.6%
2/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
1.9%
2/103 • Baseline up to Day 2511
|
1.5%
3/205 • Baseline up to Day 2511
|
2.3%
3/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Investigations
Blood glucose increased
|
25.0%
1/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Blood pressure increased
|
0.00%
0/4 • Baseline up to Day 2511
|
7.7%
1/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
CD4 lymphocytes decreased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
6.7%
1/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
1.9%
3/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
10.0%
5/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
2.9%
3/103 • Baseline up to Day 2511
|
2.0%
4/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
2.6%
4/153 • Baseline up to Day 2511
|
|
Investigations
Prothrombin time prolonged
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
6.7%
1/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • Baseline up to Day 2511
|
15.4%
2/13 • Baseline up to Day 2511
|
40.0%
6/15 • Baseline up to Day 2511
|
9.5%
2/21 • Baseline up to Day 2511
|
12.5%
1/8 • Baseline up to Day 2511
|
29.9%
55/184 • Baseline up to Day 2511
|
30.1%
47/156 • Baseline up to Day 2511
|
29.8%
50/168 • Baseline up to Day 2511
|
30.0%
18/60 • Baseline up to Day 2511
|
22.2%
20/90 • Baseline up to Day 2511
|
28.6%
6/21 • Baseline up to Day 2511
|
11.1%
2/18 • Baseline up to Day 2511
|
42.0%
21/50 • Baseline up to Day 2511
|
19.6%
10/51 • Baseline up to Day 2511
|
22.6%
12/53 • Baseline up to Day 2511
|
27.3%
12/44 • Baseline up to Day 2511
|
24.8%
31/125 • Baseline up to Day 2511
|
32.3%
20/62 • Baseline up to Day 2511
|
20.0%
4/20 • Baseline up to Day 2511
|
32.0%
33/103 • Baseline up to Day 2511
|
27.3%
56/205 • Baseline up to Day 2511
|
23.5%
31/132 • Baseline up to Day 2511
|
19.0%
29/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
1/4 • Baseline up to Day 2511
|
15.4%
2/13 • Baseline up to Day 2511
|
13.3%
2/15 • Baseline up to Day 2511
|
9.5%
2/21 • Baseline up to Day 2511
|
25.0%
2/8 • Baseline up to Day 2511
|
7.6%
14/184 • Baseline up to Day 2511
|
7.1%
11/156 • Baseline up to Day 2511
|
10.1%
17/168 • Baseline up to Day 2511
|
13.3%
8/60 • Baseline up to Day 2511
|
23.3%
21/90 • Baseline up to Day 2511
|
14.3%
3/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
20.0%
10/50 • Baseline up to Day 2511
|
13.7%
7/51 • Baseline up to Day 2511
|
11.3%
6/53 • Baseline up to Day 2511
|
22.7%
10/44 • Baseline up to Day 2511
|
24.0%
30/125 • Baseline up to Day 2511
|
12.9%
8/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
30.1%
31/103 • Baseline up to Day 2511
|
14.6%
30/205 • Baseline up to Day 2511
|
22.0%
29/132 • Baseline up to Day 2511
|
5.2%
8/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Diarrhoea
|
25.0%
1/4 • Baseline up to Day 2511
|
7.7%
1/13 • Baseline up to Day 2511
|
20.0%
3/15 • Baseline up to Day 2511
|
14.3%
3/21 • Baseline up to Day 2511
|
12.5%
1/8 • Baseline up to Day 2511
|
21.7%
40/184 • Baseline up to Day 2511
|
22.4%
35/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
15.0%
9/60 • Baseline up to Day 2511
|
13.3%
12/90 • Baseline up to Day 2511
|
23.8%
5/21 • Baseline up to Day 2511
|
27.8%
5/18 • Baseline up to Day 2511
|
28.0%
14/50 • Baseline up to Day 2511
|
27.5%
14/51 • Baseline up to Day 2511
|
20.8%
11/53 • Baseline up to Day 2511
|
29.5%
13/44 • Baseline up to Day 2511
|
24.8%
31/125 • Baseline up to Day 2511
|
33.9%
21/62 • Baseline up to Day 2511
|
30.0%
6/20 • Baseline up to Day 2511
|
24.3%
25/103 • Baseline up to Day 2511
|
19.5%
40/205 • Baseline up to Day 2511
|
9.1%
12/132 • Baseline up to Day 2511
|
17.0%
26/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
2/4 • Baseline up to Day 2511
|
7.7%
1/13 • Baseline up to Day 2511
|
13.3%
2/15 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
12.5%
1/8 • Baseline up to Day 2511
|
17.4%
32/184 • Baseline up to Day 2511
|
16.7%
26/156 • Baseline up to Day 2511
|
16.7%
28/168 • Baseline up to Day 2511
|
25.0%
15/60 • Baseline up to Day 2511
|
21.1%
19/90 • Baseline up to Day 2511
|
14.3%
3/21 • Baseline up to Day 2511
|
5.6%
1/18 • Baseline up to Day 2511
|
32.0%
16/50 • Baseline up to Day 2511
|
9.8%
5/51 • Baseline up to Day 2511
|
9.4%
5/53 • Baseline up to Day 2511
|
13.6%
6/44 • Baseline up to Day 2511
|
21.6%
27/125 • Baseline up to Day 2511
|
16.1%
10/62 • Baseline up to Day 2511
|
10.0%
2/20 • Baseline up to Day 2511
|
19.4%
20/103 • Baseline up to Day 2511
|
18.0%
37/205 • Baseline up to Day 2511
|
15.9%
21/132 • Baseline up to Day 2511
|
10.5%
16/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
13.3%
2/15 • Baseline up to Day 2511
|
9.5%
2/21 • Baseline up to Day 2511
|
25.0%
2/8 • Baseline up to Day 2511
|
23.9%
44/184 • Baseline up to Day 2511
|
28.2%
44/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
20.0%
12/60 • Baseline up to Day 2511
|
21.1%
19/90 • Baseline up to Day 2511
|
9.5%
2/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
10.0%
5/50 • Baseline up to Day 2511
|
19.6%
10/51 • Baseline up to Day 2511
|
18.9%
10/53 • Baseline up to Day 2511
|
11.4%
5/44 • Baseline up to Day 2511
|
20.8%
26/125 • Baseline up to Day 2511
|
16.1%
10/62 • Baseline up to Day 2511
|
10.0%
2/20 • Baseline up to Day 2511
|
24.3%
25/103 • Baseline up to Day 2511
|
23.4%
48/205 • Baseline up to Day 2511
|
15.2%
20/132 • Baseline up to Day 2511
|
17.6%
27/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/4 • Baseline up to Day 2511
|
7.7%
1/13 • Baseline up to Day 2511
|
6.7%
1/15 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
3.3%
6/184 • Baseline up to Day 2511
|
1.3%
2/156 • Baseline up to Day 2511
|
6.5%
11/168 • Baseline up to Day 2511
|
5.0%
3/60 • Baseline up to Day 2511
|
4.4%
4/90 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
15.2%
19/125 • Baseline up to Day 2511
|
9.7%
6/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
9.7%
10/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
3.0%
4/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/4 • Baseline up to Day 2511
|
7.7%
1/13 • Baseline up to Day 2511
|
6.7%
1/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
12.5%
1/8 • Baseline up to Day 2511
|
2.7%
5/184 • Baseline up to Day 2511
|
3.8%
6/156 • Baseline up to Day 2511
|
3.0%
5/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
4.4%
4/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
6.0%
3/50 • Baseline up to Day 2511
|
11.8%
6/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
6.8%
3/44 • Baseline up to Day 2511
|
11.2%
14/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
5.8%
6/103 • Baseline up to Day 2511
|
6.3%
13/205 • Baseline up to Day 2511
|
2.3%
3/132 • Baseline up to Day 2511
|
3.9%
6/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/4 • Baseline up to Day 2511
|
7.7%
1/13 • Baseline up to Day 2511
|
6.7%
1/15 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
2.7%
5/184 • Baseline up to Day 2511
|
1.9%
3/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
2.2%
2/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
3.8%
2/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
9.5%
2/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
2.7%
5/184 • Baseline up to Day 2511
|
5.1%
8/156 • Baseline up to Day 2511
|
4.8%
8/168 • Baseline up to Day 2511
|
6.7%
4/60 • Baseline up to Day 2511
|
10.0%
9/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
11.1%
2/18 • Baseline up to Day 2511
|
10.0%
5/50 • Baseline up to Day 2511
|
3.9%
2/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
3.2%
4/125 • Baseline up to Day 2511
|
3.2%
2/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
3.9%
4/103 • Baseline up to Day 2511
|
5.9%
12/205 • Baseline up to Day 2511
|
6.1%
8/132 • Baseline up to Day 2511
|
2.6%
4/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
6.7%
1/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
12.5%
1/8 • Baseline up to Day 2511
|
2.2%
4/184 • Baseline up to Day 2511
|
1.9%
3/156 • Baseline up to Day 2511
|
1.8%
3/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
1.3%
2/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
6.7%
1/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
1.8%
3/168 • Baseline up to Day 2511
|
3.3%
2/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
3.2%
4/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
6.7%
1/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
2.2%
4/184 • Baseline up to Day 2511
|
1.9%
3/156 • Baseline up to Day 2511
|
1.2%
2/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
2.2%
2/90 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
3.2%
2/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
1.9%
2/103 • Baseline up to Day 2511
|
2.9%
6/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
12.5%
1/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
3.0%
5/168 • Baseline up to Day 2511
|
5.0%
3/60 • Baseline up to Day 2511
|
3.3%
3/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
5.9%
3/51 • Baseline up to Day 2511
|
5.7%
3/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
8.8%
11/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
11.7%
12/103 • Baseline up to Day 2511
|
2.0%
4/205 • Baseline up to Day 2511
|
8.3%
11/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/4 • Baseline up to Day 2511
|
7.7%
1/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
2.9%
3/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
6.7%
1/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
3.8%
7/184 • Baseline up to Day 2511
|
2.6%
4/156 • Baseline up to Day 2511
|
2.4%
4/168 • Baseline up to Day 2511
|
16.7%
10/60 • Baseline up to Day 2511
|
6.7%
6/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
3.9%
2/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
1.6%
2/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
1.9%
2/103 • Baseline up to Day 2511
|
2.9%
6/205 • Baseline up to Day 2511
|
3.0%
4/132 • Baseline up to Day 2511
|
13.1%
20/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
6.7%
1/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
6.7%
1/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
6.5%
12/184 • Baseline up to Day 2511
|
2.6%
4/156 • Baseline up to Day 2511
|
1.8%
3/168 • Baseline up to Day 2511
|
5.0%
3/60 • Baseline up to Day 2511
|
3.3%
3/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
8.0%
4/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
5.7%
3/53 • Baseline up to Day 2511
|
4.5%
2/44 • Baseline up to Day 2511
|
4.0%
5/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
10.7%
11/103 • Baseline up to Day 2511
|
2.4%
5/205 • Baseline up to Day 2511
|
2.3%
3/132 • Baseline up to Day 2511
|
2.0%
3/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
6.7%
1/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.6%
3/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
6.7%
1/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
2.7%
5/184 • Baseline up to Day 2511
|
3.2%
5/156 • Baseline up to Day 2511
|
3.6%
6/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
2.2%
2/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
6.0%
3/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
5.7%
3/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
4.0%
5/125 • Baseline up to Day 2511
|
8.1%
5/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
3.9%
4/103 • Baseline up to Day 2511
|
2.0%
4/205 • Baseline up to Day 2511
|
1.5%
2/132 • Baseline up to Day 2511
|
3.3%
5/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Tongue ulceration
|
0.00%
0/4 • Baseline up to Day 2511
|
7.7%
1/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
20.0%
3/15 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
37.5%
3/8 • Baseline up to Day 2511
|
16.3%
30/184 • Baseline up to Day 2511
|
18.6%
29/156 • Baseline up to Day 2511
|
14.3%
24/168 • Baseline up to Day 2511
|
11.7%
7/60 • Baseline up to Day 2511
|
11.1%
10/90 • Baseline up to Day 2511
|
9.5%
2/21 • Baseline up to Day 2511
|
16.7%
3/18 • Baseline up to Day 2511
|
20.0%
10/50 • Baseline up to Day 2511
|
13.7%
7/51 • Baseline up to Day 2511
|
20.8%
11/53 • Baseline up to Day 2511
|
9.1%
4/44 • Baseline up to Day 2511
|
12.0%
15/125 • Baseline up to Day 2511
|
21.0%
13/62 • Baseline up to Day 2511
|
10.0%
2/20 • Baseline up to Day 2511
|
12.6%
13/103 • Baseline up to Day 2511
|
16.1%
33/205 • Baseline up to Day 2511
|
11.4%
15/132 • Baseline up to Day 2511
|
9.2%
14/153 • Baseline up to Day 2511
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4 • Baseline up to Day 2511
|
7.7%
1/13 • Baseline up to Day 2511
|
6.7%
1/15 • Baseline up to Day 2511
|
9.5%
2/21 • Baseline up to Day 2511
|
25.0%
2/8 • Baseline up to Day 2511
|
6.0%
11/184 • Baseline up to Day 2511
|
15.4%
24/156 • Baseline up to Day 2511
|
8.3%
14/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
5.6%
5/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
4.0%
2/50 • Baseline up to Day 2511
|
7.8%
4/51 • Baseline up to Day 2511
|
9.4%
5/53 • Baseline up to Day 2511
|
6.8%
3/44 • Baseline up to Day 2511
|
3.2%
4/125 • Baseline up to Day 2511
|
11.3%
7/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
7.8%
8/103 • Baseline up to Day 2511
|
6.3%
13/205 • Baseline up to Day 2511
|
4.5%
6/132 • Baseline up to Day 2511
|
4.6%
7/153 • Baseline up to Day 2511
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.0%
1/4 • Baseline up to Day 2511
|
7.7%
1/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
14.3%
3/21 • Baseline up to Day 2511
|
12.5%
1/8 • Baseline up to Day 2511
|
7.6%
14/184 • Baseline up to Day 2511
|
6.4%
10/156 • Baseline up to Day 2511
|
3.6%
6/168 • Baseline up to Day 2511
|
3.3%
2/60 • Baseline up to Day 2511
|
6.7%
6/90 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
8.0%
4/50 • Baseline up to Day 2511
|
7.8%
4/51 • Baseline up to Day 2511
|
11.3%
6/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
7.2%
9/125 • Baseline up to Day 2511
|
14.5%
9/62 • Baseline up to Day 2511
|
15.0%
3/20 • Baseline up to Day 2511
|
7.8%
8/103 • Baseline up to Day 2511
|
4.4%
9/205 • Baseline up to Day 2511
|
6.1%
8/132 • Baseline up to Day 2511
|
6.5%
10/153 • Baseline up to Day 2511
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
13.3%
2/15 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
12.5%
1/8 • Baseline up to Day 2511
|
13.0%
24/184 • Baseline up to Day 2511
|
12.8%
20/156 • Baseline up to Day 2511
|
15.5%
26/168 • Baseline up to Day 2511
|
3.3%
2/60 • Baseline up to Day 2511
|
8.9%
8/90 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
27.8%
5/18 • Baseline up to Day 2511
|
10.0%
5/50 • Baseline up to Day 2511
|
15.7%
8/51 • Baseline up to Day 2511
|
13.2%
7/53 • Baseline up to Day 2511
|
13.6%
6/44 • Baseline up to Day 2511
|
12.0%
15/125 • Baseline up to Day 2511
|
19.4%
12/62 • Baseline up to Day 2511
|
30.0%
6/20 • Baseline up to Day 2511
|
11.7%
12/103 • Baseline up to Day 2511
|
10.2%
21/205 • Baseline up to Day 2511
|
7.6%
10/132 • Baseline up to Day 2511
|
6.5%
10/153 • Baseline up to Day 2511
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/4 • Baseline up to Day 2511
|
7.7%
1/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
9.5%
2/21 • Baseline up to Day 2511
|
12.5%
1/8 • Baseline up to Day 2511
|
3.3%
6/184 • Baseline up to Day 2511
|
2.6%
4/156 • Baseline up to Day 2511
|
2.4%
4/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
3.3%
3/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
6.0%
3/50 • Baseline up to Day 2511
|
3.9%
2/51 • Baseline up to Day 2511
|
3.8%
2/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
1.6%
2/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
3.9%
4/103 • Baseline up to Day 2511
|
4.4%
9/205 • Baseline up to Day 2511
|
2.3%
3/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/4 • Baseline up to Day 2511
|
7.7%
1/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
5.4%
10/184 • Baseline up to Day 2511
|
1.9%
3/156 • Baseline up to Day 2511
|
6.0%
10/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
5.9%
3/51 • Baseline up to Day 2511
|
5.7%
3/53 • Baseline up to Day 2511
|
4.5%
2/44 • Baseline up to Day 2511
|
7.2%
9/125 • Baseline up to Day 2511
|
8.1%
5/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
6.8%
7/103 • Baseline up to Day 2511
|
3.9%
8/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
1.3%
2/153 • Baseline up to Day 2511
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
6.7%
1/15 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
3.8%
7/184 • Baseline up to Day 2511
|
5.1%
8/156 • Baseline up to Day 2511
|
2.4%
4/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
8.0%
4/50 • Baseline up to Day 2511
|
3.9%
2/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
3.2%
4/125 • Baseline up to Day 2511
|
6.5%
4/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
2.9%
3/103 • Baseline up to Day 2511
|
1.5%
3/205 • Baseline up to Day 2511
|
1.5%
2/132 • Baseline up to Day 2511
|
2.0%
3/153 • Baseline up to Day 2511
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/4 • Baseline up to Day 2511
|
7.7%
1/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
8.7%
16/184 • Baseline up to Day 2511
|
5.8%
9/156 • Baseline up to Day 2511
|
5.4%
9/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
5.6%
1/18 • Baseline up to Day 2511
|
10.0%
5/50 • Baseline up to Day 2511
|
7.8%
4/51 • Baseline up to Day 2511
|
15.1%
8/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
4.8%
3/62 • Baseline up to Day 2511
|
15.0%
3/20 • Baseline up to Day 2511
|
4.9%
5/103 • Baseline up to Day 2511
|
2.9%
6/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
3.9%
6/153 • Baseline up to Day 2511
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
13.3%
2/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
9.8%
18/184 • Baseline up to Day 2511
|
10.3%
16/156 • Baseline up to Day 2511
|
7.7%
13/168 • Baseline up to Day 2511
|
3.3%
2/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
9.5%
2/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
6.0%
3/50 • Baseline up to Day 2511
|
7.8%
4/51 • Baseline up to Day 2511
|
17.0%
9/53 • Baseline up to Day 2511
|
18.2%
8/44 • Baseline up to Day 2511
|
4.8%
6/125 • Baseline up to Day 2511
|
16.1%
10/62 • Baseline up to Day 2511
|
20.0%
4/20 • Baseline up to Day 2511
|
2.9%
3/103 • Baseline up to Day 2511
|
7.3%
15/205 • Baseline up to Day 2511
|
1.5%
2/132 • Baseline up to Day 2511
|
5.2%
8/153 • Baseline up to Day 2511
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
12.5%
1/8 • Baseline up to Day 2511
|
4.9%
9/184 • Baseline up to Day 2511
|
4.5%
7/156 • Baseline up to Day 2511
|
6.0%
10/168 • Baseline up to Day 2511
|
3.3%
2/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
4.0%
2/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
3.8%
2/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
3.2%
4/125 • Baseline up to Day 2511
|
4.8%
3/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
3.9%
4/103 • Baseline up to Day 2511
|
3.9%
8/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
9.2%
14/153 • Baseline up to Day 2511
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
12.5%
1/8 • Baseline up to Day 2511
|
2.7%
5/184 • Baseline up to Day 2511
|
4.5%
7/156 • Baseline up to Day 2511
|
3.0%
5/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
11.1%
2/18 • Baseline up to Day 2511
|
4.0%
2/50 • Baseline up to Day 2511
|
3.9%
2/51 • Baseline up to Day 2511
|
3.8%
2/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
1.6%
2/125 • Baseline up to Day 2511
|
3.2%
2/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
2.9%
3/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
2.0%
3/153 • Baseline up to Day 2511
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
6.7%
1/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
1.8%
3/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
3.9%
8/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
1.3%
2/153 • Baseline up to Day 2511
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
6.7%
1/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
12.5%
1/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4 • Baseline up to Day 2511
|
7.7%
1/13 • Baseline up to Day 2511
|
20.0%
3/15 • Baseline up to Day 2511
|
14.3%
3/21 • Baseline up to Day 2511
|
12.5%
1/8 • Baseline up to Day 2511
|
27.7%
51/184 • Baseline up to Day 2511
|
16.7%
26/156 • Baseline up to Day 2511
|
13.7%
23/168 • Baseline up to Day 2511
|
8.3%
5/60 • Baseline up to Day 2511
|
12.2%
11/90 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
16.7%
3/18 • Baseline up to Day 2511
|
30.0%
15/50 • Baseline up to Day 2511
|
21.6%
11/51 • Baseline up to Day 2511
|
37.7%
20/53 • Baseline up to Day 2511
|
11.4%
5/44 • Baseline up to Day 2511
|
7.2%
9/125 • Baseline up to Day 2511
|
35.5%
22/62 • Baseline up to Day 2511
|
15.0%
3/20 • Baseline up to Day 2511
|
8.7%
9/103 • Baseline up to Day 2511
|
18.0%
37/205 • Baseline up to Day 2511
|
10.6%
14/132 • Baseline up to Day 2511
|
8.5%
13/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/4 • Baseline up to Day 2511
|
15.4%
2/13 • Baseline up to Day 2511
|
6.7%
1/15 • Baseline up to Day 2511
|
9.5%
2/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.6%
3/184 • Baseline up to Day 2511
|
3.2%
5/156 • Baseline up to Day 2511
|
1.8%
3/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
5.6%
1/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
2.4%
3/125 • Baseline up to Day 2511
|
3.2%
2/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/4 • Baseline up to Day 2511
|
7.7%
1/13 • Baseline up to Day 2511
|
6.7%
1/15 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
14.1%
26/184 • Baseline up to Day 2511
|
21.2%
33/156 • Baseline up to Day 2511
|
11.3%
19/168 • Baseline up to Day 2511
|
10.0%
6/60 • Baseline up to Day 2511
|
2.2%
2/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
24.0%
12/50 • Baseline up to Day 2511
|
13.7%
7/51 • Baseline up to Day 2511
|
26.4%
14/53 • Baseline up to Day 2511
|
20.5%
9/44 • Baseline up to Day 2511
|
10.4%
13/125 • Baseline up to Day 2511
|
22.6%
14/62 • Baseline up to Day 2511
|
40.0%
8/20 • Baseline up to Day 2511
|
20.4%
21/103 • Baseline up to Day 2511
|
16.1%
33/205 • Baseline up to Day 2511
|
7.6%
10/132 • Baseline up to Day 2511
|
10.5%
16/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
6.7%
1/15 • Baseline up to Day 2511
|
9.5%
2/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
13.6%
25/184 • Baseline up to Day 2511
|
7.7%
12/156 • Baseline up to Day 2511
|
14.3%
24/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
4.4%
4/90 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
16.0%
8/50 • Baseline up to Day 2511
|
7.8%
4/51 • Baseline up to Day 2511
|
9.4%
5/53 • Baseline up to Day 2511
|
6.8%
3/44 • Baseline up to Day 2511
|
6.4%
8/125 • Baseline up to Day 2511
|
4.8%
3/62 • Baseline up to Day 2511
|
10.0%
2/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
3.4%
7/205 • Baseline up to Day 2511
|
2.3%
3/132 • Baseline up to Day 2511
|
1.3%
2/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
6.7%
1/15 • Baseline up to Day 2511
|
9.5%
2/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
7.1%
13/184 • Baseline up to Day 2511
|
7.1%
11/156 • Baseline up to Day 2511
|
2.4%
4/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
2.2%
2/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
8.0%
4/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
9.4%
5/53 • Baseline up to Day 2511
|
6.8%
3/44 • Baseline up to Day 2511
|
1.6%
2/125 • Baseline up to Day 2511
|
8.1%
5/62 • Baseline up to Day 2511
|
15.0%
3/20 • Baseline up to Day 2511
|
1.9%
2/103 • Baseline up to Day 2511
|
4.4%
9/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
8.5%
13/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
6.7%
1/15 • Baseline up to Day 2511
|
9.5%
2/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
4.3%
8/184 • Baseline up to Day 2511
|
2.6%
4/156 • Baseline up to Day 2511
|
3.6%
6/168 • Baseline up to Day 2511
|
3.3%
2/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
4.0%
2/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
3.8%
2/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
20.0%
4/20 • Baseline up to Day 2511
|
2.9%
3/103 • Baseline up to Day 2511
|
1.5%
3/205 • Baseline up to Day 2511
|
1.5%
2/132 • Baseline up to Day 2511
|
1.3%
2/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
6.7%
1/15 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
3.8%
7/184 • Baseline up to Day 2511
|
2.6%
4/156 • Baseline up to Day 2511
|
6.0%
10/168 • Baseline up to Day 2511
|
3.3%
2/60 • Baseline up to Day 2511
|
2.2%
2/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
6.0%
3/50 • Baseline up to Day 2511
|
5.9%
3/51 • Baseline up to Day 2511
|
9.4%
5/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
4.0%
5/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
10.0%
2/20 • Baseline up to Day 2511
|
4.9%
5/103 • Baseline up to Day 2511
|
3.9%
8/205 • Baseline up to Day 2511
|
6.1%
8/132 • Baseline up to Day 2511
|
2.0%
3/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/4 • Baseline up to Day 2511
|
7.7%
1/13 • Baseline up to Day 2511
|
6.7%
1/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
3.8%
7/184 • Baseline up to Day 2511
|
1.3%
2/156 • Baseline up to Day 2511
|
1.2%
2/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
2.2%
2/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
1.5%
3/205 • Baseline up to Day 2511
|
1.5%
2/132 • Baseline up to Day 2511
|
2.6%
4/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
6.7%
1/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
6.7%
1/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
3.3%
6/184 • Baseline up to Day 2511
|
3.2%
5/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
4.0%
2/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
6.5%
4/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
1.9%
2/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
3.3%
5/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/4 • Baseline up to Day 2511
|
7.7%
1/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
2.2%
4/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
2.4%
3/125 • Baseline up to Day 2511
|
3.2%
2/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
1.5%
3/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
3.3%
5/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
6.7%
1/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
6.5%
12/184 • Baseline up to Day 2511
|
4.5%
7/156 • Baseline up to Day 2511
|
3.0%
5/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
5.6%
1/18 • Baseline up to Day 2511
|
4.0%
2/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
3.8%
2/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
3.2%
4/125 • Baseline up to Day 2511
|
3.2%
2/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
3.9%
4/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
1.5%
2/132 • Baseline up to Day 2511
|
2.0%
3/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
6.7%
1/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
4.9%
9/184 • Baseline up to Day 2511
|
5.1%
8/156 • Baseline up to Day 2511
|
4.2%
7/168 • Baseline up to Day 2511
|
3.3%
2/60 • Baseline up to Day 2511
|
2.2%
2/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
4.0%
2/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
4.5%
2/44 • Baseline up to Day 2511
|
3.2%
4/125 • Baseline up to Day 2511
|
4.8%
3/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
8.7%
9/103 • Baseline up to Day 2511
|
3.4%
7/205 • Baseline up to Day 2511
|
1.5%
2/132 • Baseline up to Day 2511
|
3.3%
5/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
2.6%
4/156 • Baseline up to Day 2511
|
1.2%
2/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
1.9%
2/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
6.7%
1/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
3.2%
5/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
4.0%
2/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
4.5%
2/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
2.9%
6/205 • Baseline up to Day 2511
|
2.3%
3/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory symptom
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
12.5%
1/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Upper respiratory tract infection
|
25.0%
1/4 • Baseline up to Day 2511
|
15.4%
2/13 • Baseline up to Day 2511
|
13.3%
2/15 • Baseline up to Day 2511
|
9.5%
2/21 • Baseline up to Day 2511
|
25.0%
2/8 • Baseline up to Day 2511
|
11.4%
21/184 • Baseline up to Day 2511
|
13.5%
21/156 • Baseline up to Day 2511
|
3.0%
5/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
8.9%
8/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
5.6%
1/18 • Baseline up to Day 2511
|
8.0%
4/50 • Baseline up to Day 2511
|
9.8%
5/51 • Baseline up to Day 2511
|
11.3%
6/53 • Baseline up to Day 2511
|
4.5%
2/44 • Baseline up to Day 2511
|
8.8%
11/125 • Baseline up to Day 2511
|
11.3%
7/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
6.8%
7/103 • Baseline up to Day 2511
|
5.9%
12/205 • Baseline up to Day 2511
|
1.5%
2/132 • Baseline up to Day 2511
|
6.5%
10/153 • Baseline up to Day 2511
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • Baseline up to Day 2511
|
7.7%
1/13 • Baseline up to Day 2511
|
6.7%
1/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
12.5%
1/8 • Baseline up to Day 2511
|
8.2%
15/184 • Baseline up to Day 2511
|
5.8%
9/156 • Baseline up to Day 2511
|
1.8%
3/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
6.0%
3/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
4.0%
5/125 • Baseline up to Day 2511
|
6.5%
4/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
1.9%
2/103 • Baseline up to Day 2511
|
2.4%
5/205 • Baseline up to Day 2511
|
1.5%
2/132 • Baseline up to Day 2511
|
4.6%
7/153 • Baseline up to Day 2511
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
9.5%
2/21 • Baseline up to Day 2511
|
12.5%
1/8 • Baseline up to Day 2511
|
10.3%
19/184 • Baseline up to Day 2511
|
9.0%
14/156 • Baseline up to Day 2511
|
10.1%
17/168 • Baseline up to Day 2511
|
3.3%
2/60 • Baseline up to Day 2511
|
2.2%
2/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
5.6%
1/18 • Baseline up to Day 2511
|
8.0%
4/50 • Baseline up to Day 2511
|
13.7%
7/51 • Baseline up to Day 2511
|
5.7%
3/53 • Baseline up to Day 2511
|
15.9%
7/44 • Baseline up to Day 2511
|
16.8%
21/125 • Baseline up to Day 2511
|
12.9%
8/62 • Baseline up to Day 2511
|
10.0%
2/20 • Baseline up to Day 2511
|
17.5%
18/103 • Baseline up to Day 2511
|
22.9%
47/205 • Baseline up to Day 2511
|
4.5%
6/132 • Baseline up to Day 2511
|
5.2%
8/153 • Baseline up to Day 2511
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
9.5%
2/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
1.3%
2/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
9.7%
6/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Hordeolum
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
12.5%
1/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
2.2%
2/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
4.0%
2/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Bronchitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
7.1%
13/184 • Baseline up to Day 2511
|
9.6%
15/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
2.2%
2/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
2.4%
3/125 • Baseline up to Day 2511
|
3.2%
2/62 • Baseline up to Day 2511
|
10.0%
2/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
2.9%
6/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
3.9%
6/153 • Baseline up to Day 2511
|
|
Infections and infestations
Enterocolitis viral
|
0.00%
0/4 • Baseline up to Day 2511
|
7.7%
1/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Localised infection
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
12.5%
1/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Otitis media
|
0.00%
0/4 • Baseline up to Day 2511
|
7.7%
1/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Sinusitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
12.5%
1/8 • Baseline up to Day 2511
|
3.3%
6/184 • Baseline up to Day 2511
|
1.9%
3/156 • Baseline up to Day 2511
|
1.2%
2/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
3.8%
2/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
3.2%
4/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
1.9%
2/103 • Baseline up to Day 2511
|
2.0%
4/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
3.3%
5/153 • Baseline up to Day 2511
|
|
Infections and infestations
Sinusitis bacterial
|
0.00%
0/4 • Baseline up to Day 2511
|
7.7%
1/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
2.4%
4/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Staphylococcal infection
|
25.0%
1/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Parosmia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/4 • Baseline up to Day 2511
|
7.7%
1/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
1.3%
2/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
8.9%
8/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
4.5%
2/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Blood and lymphatic system disorders
Anaemia
|
50.0%
2/4 • Baseline up to Day 2511
|
30.8%
4/13 • Baseline up to Day 2511
|
40.0%
6/15 • Baseline up to Day 2511
|
14.3%
3/21 • Baseline up to Day 2511
|
12.5%
1/8 • Baseline up to Day 2511
|
15.2%
28/184 • Baseline up to Day 2511
|
14.1%
22/156 • Baseline up to Day 2511
|
10.7%
18/168 • Baseline up to Day 2511
|
20.0%
12/60 • Baseline up to Day 2511
|
14.4%
13/90 • Baseline up to Day 2511
|
23.8%
5/21 • Baseline up to Day 2511
|
11.1%
2/18 • Baseline up to Day 2511
|
32.0%
16/50 • Baseline up to Day 2511
|
13.7%
7/51 • Baseline up to Day 2511
|
22.6%
12/53 • Baseline up to Day 2511
|
27.3%
12/44 • Baseline up to Day 2511
|
7.2%
9/125 • Baseline up to Day 2511
|
6.5%
4/62 • Baseline up to Day 2511
|
15.0%
3/20 • Baseline up to Day 2511
|
10.7%
11/103 • Baseline up to Day 2511
|
17.6%
36/205 • Baseline up to Day 2511
|
22.7%
30/132 • Baseline up to Day 2511
|
16.3%
25/153 • Baseline up to Day 2511
|
|
Blood and lymphatic system disorders
Lymphopenia
|
50.0%
2/4 • Baseline up to Day 2511
|
23.1%
3/13 • Baseline up to Day 2511
|
13.3%
2/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
1.3%
2/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
6.0%
3/50 • Baseline up to Day 2511
|
5.9%
3/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
1.6%
2/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
1.5%
2/132 • Baseline up to Day 2511
|
3.3%
5/153 • Baseline up to Day 2511
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/4 • Baseline up to Day 2511
|
7.7%
1/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
1.3%
2/156 • Baseline up to Day 2511
|
1.8%
3/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
1.5%
2/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Peripheral sensorimotor neuropathy
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
25.0%
1/4 • Baseline up to Day 2511
|
15.4%
2/13 • Baseline up to Day 2511
|
20.0%
3/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
12.5%
1/8 • Baseline up to Day 2511
|
6.0%
11/184 • Baseline up to Day 2511
|
3.8%
6/156 • Baseline up to Day 2511
|
2.4%
4/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
4.4%
4/90 • Baseline up to Day 2511
|
19.0%
4/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
3.9%
2/51 • Baseline up to Day 2511
|
9.4%
5/53 • Baseline up to Day 2511
|
9.1%
4/44 • Baseline up to Day 2511
|
1.6%
2/125 • Baseline up to Day 2511
|
6.5%
4/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
3.9%
4/103 • Baseline up to Day 2511
|
3.9%
8/205 • Baseline up to Day 2511
|
3.0%
4/132 • Baseline up to Day 2511
|
1.3%
2/153 • Baseline up to Day 2511
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
50.0%
2/4 • Baseline up to Day 2511
|
15.4%
2/13 • Baseline up to Day 2511
|
6.7%
1/15 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
4.3%
8/184 • Baseline up to Day 2511
|
3.8%
6/156 • Baseline up to Day 2511
|
3.6%
6/168 • Baseline up to Day 2511
|
5.0%
3/60 • Baseline up to Day 2511
|
3.3%
3/90 • Baseline up to Day 2511
|
14.3%
3/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
8.0%
4/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
17.0%
9/53 • Baseline up to Day 2511
|
4.5%
2/44 • Baseline up to Day 2511
|
4.0%
5/125 • Baseline up to Day 2511
|
3.2%
2/62 • Baseline up to Day 2511
|
10.0%
2/20 • Baseline up to Day 2511
|
4.9%
5/103 • Baseline up to Day 2511
|
3.4%
7/205 • Baseline up to Day 2511
|
6.8%
9/132 • Baseline up to Day 2511
|
5.2%
8/153 • Baseline up to Day 2511
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
25.0%
1/4 • Baseline up to Day 2511
|
30.8%
4/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
12.5%
1/8 • Baseline up to Day 2511
|
9.2%
17/184 • Baseline up to Day 2511
|
10.9%
17/156 • Baseline up to Day 2511
|
5.4%
9/168 • Baseline up to Day 2511
|
10.0%
6/60 • Baseline up to Day 2511
|
3.3%
3/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
12.0%
6/50 • Baseline up to Day 2511
|
11.8%
6/51 • Baseline up to Day 2511
|
3.8%
2/53 • Baseline up to Day 2511
|
9.1%
4/44 • Baseline up to Day 2511
|
6.4%
8/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
10.7%
11/103 • Baseline up to Day 2511
|
4.9%
10/205 • Baseline up to Day 2511
|
11.4%
15/132 • Baseline up to Day 2511
|
7.2%
11/153 • Baseline up to Day 2511
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
50.0%
2/4 • Baseline up to Day 2511
|
15.4%
2/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
8.7%
16/184 • Baseline up to Day 2511
|
10.9%
17/156 • Baseline up to Day 2511
|
1.8%
3/168 • Baseline up to Day 2511
|
10.0%
6/60 • Baseline up to Day 2511
|
4.4%
4/90 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
12.0%
6/50 • Baseline up to Day 2511
|
3.9%
2/51 • Baseline up to Day 2511
|
3.8%
2/53 • Baseline up to Day 2511
|
13.6%
6/44 • Baseline up to Day 2511
|
5.6%
7/125 • Baseline up to Day 2511
|
6.5%
4/62 • Baseline up to Day 2511
|
15.0%
3/20 • Baseline up to Day 2511
|
11.7%
12/103 • Baseline up to Day 2511
|
8.8%
18/205 • Baseline up to Day 2511
|
9.1%
12/132 • Baseline up to Day 2511
|
7.2%
11/153 • Baseline up to Day 2511
|
|
Metabolism and nutrition disorders
Decreased appetite
|
25.0%
1/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
13.3%
2/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
22.8%
42/184 • Baseline up to Day 2511
|
23.1%
36/156 • Baseline up to Day 2511
|
19.6%
33/168 • Baseline up to Day 2511
|
28.3%
17/60 • Baseline up to Day 2511
|
15.6%
14/90 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
26.0%
13/50 • Baseline up to Day 2511
|
17.6%
9/51 • Baseline up to Day 2511
|
22.6%
12/53 • Baseline up to Day 2511
|
20.5%
9/44 • Baseline up to Day 2511
|
16.8%
21/125 • Baseline up to Day 2511
|
27.4%
17/62 • Baseline up to Day 2511
|
15.0%
3/20 • Baseline up to Day 2511
|
18.4%
19/103 • Baseline up to Day 2511
|
25.9%
53/205 • Baseline up to Day 2511
|
23.5%
31/132 • Baseline up to Day 2511
|
11.8%
18/153 • Baseline up to Day 2511
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/4 • Baseline up to Day 2511
|
15.4%
2/13 • Baseline up to Day 2511
|
6.7%
1/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
7.1%
13/184 • Baseline up to Day 2511
|
3.2%
5/156 • Baseline up to Day 2511
|
1.8%
3/168 • Baseline up to Day 2511
|
5.0%
3/60 • Baseline up to Day 2511
|
2.2%
2/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
14.0%
7/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
5.7%
3/53 • Baseline up to Day 2511
|
4.5%
2/44 • Baseline up to Day 2511
|
7.2%
9/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
12.6%
13/103 • Baseline up to Day 2511
|
5.9%
12/205 • Baseline up to Day 2511
|
6.8%
9/132 • Baseline up to Day 2511
|
4.6%
7/153 • Baseline up to Day 2511
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
12.5%
1/8 • Baseline up to Day 2511
|
2.7%
5/184 • Baseline up to Day 2511
|
2.6%
4/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
3.3%
2/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
5.6%
1/18 • Baseline up to Day 2511
|
8.0%
4/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
4.5%
2/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
6.5%
4/62 • Baseline up to Day 2511
|
15.0%
3/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
4.9%
10/205 • Baseline up to Day 2511
|
3.0%
4/132 • Baseline up to Day 2511
|
3.3%
5/153 • Baseline up to Day 2511
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
50.0%
2/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
1.3%
2/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
5.0%
3/60 • Baseline up to Day 2511
|
3.3%
3/90 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
10.0%
5/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
3.8%
2/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
2.9%
3/103 • Baseline up to Day 2511
|
1.5%
3/205 • Baseline up to Day 2511
|
4.5%
6/132 • Baseline up to Day 2511
|
3.3%
5/153 • Baseline up to Day 2511
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
6.7%
1/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
2.6%
4/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
2.2%
2/90 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
3.8%
2/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
25.0%
1/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
6.0%
11/184 • Baseline up to Day 2511
|
3.8%
6/156 • Baseline up to Day 2511
|
1.2%
2/168 • Baseline up to Day 2511
|
5.0%
3/60 • Baseline up to Day 2511
|
2.2%
2/90 • Baseline up to Day 2511
|
9.5%
2/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
16.0%
8/50 • Baseline up to Day 2511
|
7.8%
4/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
4.5%
2/44 • Baseline up to Day 2511
|
1.6%
2/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
10.0%
2/20 • Baseline up to Day 2511
|
3.9%
4/103 • Baseline up to Day 2511
|
5.9%
12/205 • Baseline up to Day 2511
|
2.3%
3/132 • Baseline up to Day 2511
|
5.9%
9/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Rash
|
25.0%
1/4 • Baseline up to Day 2511
|
7.7%
1/13 • Baseline up to Day 2511
|
13.3%
2/15 • Baseline up to Day 2511
|
9.5%
2/21 • Baseline up to Day 2511
|
25.0%
2/8 • Baseline up to Day 2511
|
6.5%
12/184 • Baseline up to Day 2511
|
10.9%
17/156 • Baseline up to Day 2511
|
4.2%
7/168 • Baseline up to Day 2511
|
3.3%
2/60 • Baseline up to Day 2511
|
12.2%
11/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
5.6%
1/18 • Baseline up to Day 2511
|
20.0%
10/50 • Baseline up to Day 2511
|
7.8%
4/51 • Baseline up to Day 2511
|
9.4%
5/53 • Baseline up to Day 2511
|
9.1%
4/44 • Baseline up to Day 2511
|
10.4%
13/125 • Baseline up to Day 2511
|
17.7%
11/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
5.8%
6/103 • Baseline up to Day 2511
|
11.2%
23/205 • Baseline up to Day 2511
|
4.5%
6/132 • Baseline up to Day 2511
|
7.8%
12/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
25.0%
2/8 • Baseline up to Day 2511
|
5.4%
10/184 • Baseline up to Day 2511
|
9.0%
14/156 • Baseline up to Day 2511
|
5.4%
9/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
15.6%
14/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
14.0%
7/50 • Baseline up to Day 2511
|
11.8%
6/51 • Baseline up to Day 2511
|
13.2%
7/53 • Baseline up to Day 2511
|
13.6%
6/44 • Baseline up to Day 2511
|
7.2%
9/125 • Baseline up to Day 2511
|
24.2%
15/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
5.8%
6/103 • Baseline up to Day 2511
|
13.2%
27/205 • Baseline up to Day 2511
|
6.1%
8/132 • Baseline up to Day 2511
|
11.8%
18/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
6.7%
1/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
12.5%
1/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
1.9%
2/103 • Baseline up to Day 2511
|
2.0%
4/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
12.5%
1/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
2.2%
2/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
4.0%
2/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
3.2%
5/156 • Baseline up to Day 2511
|
3.0%
5/168 • Baseline up to Day 2511
|
5.0%
3/60 • Baseline up to Day 2511
|
3.3%
3/90 • Baseline up to Day 2511
|
9.5%
2/21 • Baseline up to Day 2511
|
11.1%
2/18 • Baseline up to Day 2511
|
8.0%
4/50 • Baseline up to Day 2511
|
3.9%
2/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
11.4%
5/44 • Baseline up to Day 2511
|
7.2%
9/125 • Baseline up to Day 2511
|
3.2%
2/62 • Baseline up to Day 2511
|
10.0%
2/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
3.9%
8/205 • Baseline up to Day 2511
|
1.5%
2/132 • Baseline up to Day 2511
|
1.3%
2/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
12.5%
1/8 • Baseline up to Day 2511
|
2.7%
5/184 • Baseline up to Day 2511
|
1.3%
2/156 • Baseline up to Day 2511
|
1.2%
2/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
2.2%
2/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
3.9%
2/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
4.5%
2/44 • Baseline up to Day 2511
|
1.6%
2/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
2.0%
4/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Rash vesicular
|
25.0%
1/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
12.5%
1/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • Baseline up to Day 2511
|
7.7%
1/13 • Baseline up to Day 2511
|
20.0%
3/15 • Baseline up to Day 2511
|
14.3%
3/21 • Baseline up to Day 2511
|
12.5%
1/8 • Baseline up to Day 2511
|
4.3%
8/184 • Baseline up to Day 2511
|
16.7%
26/156 • Baseline up to Day 2511
|
7.1%
12/168 • Baseline up to Day 2511
|
3.3%
2/60 • Baseline up to Day 2511
|
5.6%
5/90 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
24.0%
12/50 • Baseline up to Day 2511
|
9.8%
5/51 • Baseline up to Day 2511
|
11.3%
6/53 • Baseline up to Day 2511
|
9.1%
4/44 • Baseline up to Day 2511
|
10.4%
13/125 • Baseline up to Day 2511
|
9.7%
6/62 • Baseline up to Day 2511
|
20.0%
4/20 • Baseline up to Day 2511
|
10.7%
11/103 • Baseline up to Day 2511
|
14.6%
30/205 • Baseline up to Day 2511
|
6.8%
9/132 • Baseline up to Day 2511
|
12.4%
19/153 • Baseline up to Day 2511
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
14.3%
3/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
4.9%
9/184 • Baseline up to Day 2511
|
3.8%
6/156 • Baseline up to Day 2511
|
1.8%
3/168 • Baseline up to Day 2511
|
3.3%
2/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
6.0%
3/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
7.5%
4/53 • Baseline up to Day 2511
|
11.4%
5/44 • Baseline up to Day 2511
|
3.2%
4/125 • Baseline up to Day 2511
|
4.8%
3/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
2.9%
3/103 • Baseline up to Day 2511
|
2.9%
6/205 • Baseline up to Day 2511
|
3.8%
5/132 • Baseline up to Day 2511
|
2.6%
4/153 • Baseline up to Day 2511
|
|
Vascular disorders
Embolism
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
6.7%
1/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • Baseline up to Day 2511
|
15.4%
2/13 • Baseline up to Day 2511
|
6.7%
1/15 • Baseline up to Day 2511
|
14.3%
3/21 • Baseline up to Day 2511
|
12.5%
1/8 • Baseline up to Day 2511
|
14.7%
27/184 • Baseline up to Day 2511
|
17.3%
27/156 • Baseline up to Day 2511
|
8.9%
15/168 • Baseline up to Day 2511
|
3.3%
2/60 • Baseline up to Day 2511
|
8.9%
8/90 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
5.6%
1/18 • Baseline up to Day 2511
|
12.0%
6/50 • Baseline up to Day 2511
|
9.8%
5/51 • Baseline up to Day 2511
|
7.5%
4/53 • Baseline up to Day 2511
|
9.1%
4/44 • Baseline up to Day 2511
|
12.8%
16/125 • Baseline up to Day 2511
|
14.5%
9/62 • Baseline up to Day 2511
|
20.0%
4/20 • Baseline up to Day 2511
|
5.8%
6/103 • Baseline up to Day 2511
|
7.8%
16/205 • Baseline up to Day 2511
|
6.1%
8/132 • Baseline up to Day 2511
|
11.1%
17/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
12.5%
1/8 • Baseline up to Day 2511
|
12.0%
22/184 • Baseline up to Day 2511
|
10.9%
17/156 • Baseline up to Day 2511
|
6.5%
11/168 • Baseline up to Day 2511
|
8.3%
5/60 • Baseline up to Day 2511
|
7.8%
7/90 • Baseline up to Day 2511
|
9.5%
2/21 • Baseline up to Day 2511
|
5.6%
1/18 • Baseline up to Day 2511
|
8.0%
4/50 • Baseline up to Day 2511
|
7.8%
4/51 • Baseline up to Day 2511
|
9.4%
5/53 • Baseline up to Day 2511
|
9.1%
4/44 • Baseline up to Day 2511
|
7.2%
9/125 • Baseline up to Day 2511
|
8.1%
5/62 • Baseline up to Day 2511
|
15.0%
3/20 • Baseline up to Day 2511
|
11.7%
12/103 • Baseline up to Day 2511
|
5.9%
12/205 • Baseline up to Day 2511
|
3.8%
5/132 • Baseline up to Day 2511
|
8.5%
13/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Lethargy
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.6%
3/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
3.0%
5/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
6.7%
1/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
2.7%
5/184 • Baseline up to Day 2511
|
1.3%
2/156 • Baseline up to Day 2511
|
1.8%
3/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
4.0%
2/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
1.6%
2/125 • Baseline up to Day 2511
|
4.8%
3/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
1.9%
2/103 • Baseline up to Day 2511
|
1.5%
3/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
2.6%
4/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
6.7%
1/15 • Baseline up to Day 2511
|
14.3%
3/21 • Baseline up to Day 2511
|
50.0%
4/8 • Baseline up to Day 2511
|
19.0%
35/184 • Baseline up to Day 2511
|
16.0%
25/156 • Baseline up to Day 2511
|
14.3%
24/168 • Baseline up to Day 2511
|
10.0%
6/60 • Baseline up to Day 2511
|
14.4%
13/90 • Baseline up to Day 2511
|
28.6%
6/21 • Baseline up to Day 2511
|
22.2%
4/18 • Baseline up to Day 2511
|
12.0%
6/50 • Baseline up to Day 2511
|
23.5%
12/51 • Baseline up to Day 2511
|
35.8%
19/53 • Baseline up to Day 2511
|
20.5%
9/44 • Baseline up to Day 2511
|
13.6%
17/125 • Baseline up to Day 2511
|
19.4%
12/62 • Baseline up to Day 2511
|
25.0%
5/20 • Baseline up to Day 2511
|
16.5%
17/103 • Baseline up to Day 2511
|
22.9%
47/205 • Baseline up to Day 2511
|
13.6%
18/132 • Baseline up to Day 2511
|
8.5%
13/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
4.3%
8/184 • Baseline up to Day 2511
|
7.7%
12/156 • Baseline up to Day 2511
|
3.6%
6/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
6.0%
3/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
5.7%
3/53 • Baseline up to Day 2511
|
9.1%
4/44 • Baseline up to Day 2511
|
2.4%
3/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
10.0%
2/20 • Baseline up to Day 2511
|
6.8%
7/103 • Baseline up to Day 2511
|
4.4%
9/205 • Baseline up to Day 2511
|
3.8%
5/132 • Baseline up to Day 2511
|
5.2%
8/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
12.5%
1/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
2.6%
4/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Psychiatric disorders
Insomnia
|
25.0%
1/4 • Baseline up to Day 2511
|
7.7%
1/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
12.5%
1/8 • Baseline up to Day 2511
|
7.6%
14/184 • Baseline up to Day 2511
|
8.3%
13/156 • Baseline up to Day 2511
|
7.7%
13/168 • Baseline up to Day 2511
|
8.3%
5/60 • Baseline up to Day 2511
|
8.9%
8/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
5.6%
1/18 • Baseline up to Day 2511
|
8.0%
4/50 • Baseline up to Day 2511
|
9.8%
5/51 • Baseline up to Day 2511
|
11.3%
6/53 • Baseline up to Day 2511
|
4.5%
2/44 • Baseline up to Day 2511
|
9.6%
12/125 • Baseline up to Day 2511
|
4.8%
3/62 • Baseline up to Day 2511
|
15.0%
3/20 • Baseline up to Day 2511
|
5.8%
6/103 • Baseline up to Day 2511
|
8.3%
17/205 • Baseline up to Day 2511
|
9.8%
13/132 • Baseline up to Day 2511
|
3.3%
5/153 • Baseline up to Day 2511
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
12.5%
1/8 • Baseline up to Day 2511
|
14.7%
27/184 • Baseline up to Day 2511
|
7.1%
11/156 • Baseline up to Day 2511
|
6.5%
11/168 • Baseline up to Day 2511
|
8.3%
5/60 • Baseline up to Day 2511
|
4.4%
4/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
5.6%
1/18 • Baseline up to Day 2511
|
4.0%
2/50 • Baseline up to Day 2511
|
3.9%
2/51 • Baseline up to Day 2511
|
5.7%
3/53 • Baseline up to Day 2511
|
11.4%
5/44 • Baseline up to Day 2511
|
4.8%
6/125 • Baseline up to Day 2511
|
3.2%
2/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
7.8%
8/103 • Baseline up to Day 2511
|
8.3%
17/205 • Baseline up to Day 2511
|
2.3%
3/132 • Baseline up to Day 2511
|
4.6%
7/153 • Baseline up to Day 2511
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
6.7%
1/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
6.7%
1/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
1.2%
2/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
4.0%
2/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/4 • Baseline up to Day 2511
|
15.4%
2/13 • Baseline up to Day 2511
|
6.7%
1/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.6%
3/184 • Baseline up to Day 2511
|
2.6%
4/156 • Baseline up to Day 2511
|
1.8%
3/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
2.2%
2/90 • Baseline up to Day 2511
|
9.5%
2/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
10.0%
5/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
2.4%
3/125 • Baseline up to Day 2511
|
4.8%
3/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
1.9%
2/103 • Baseline up to Day 2511
|
2.0%
4/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
3.3%
6/184 • Baseline up to Day 2511
|
3.2%
5/156 • Baseline up to Day 2511
|
1.2%
2/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
3.3%
3/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
3.9%
2/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
4.5%
2/44 • Baseline up to Day 2511
|
4.0%
5/125 • Baseline up to Day 2511
|
6.5%
4/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
5.4%
11/205 • Baseline up to Day 2511
|
1.5%
2/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Renal and urinary disorders
Haemoglobinuria
|
0.00%
0/4 • Baseline up to Day 2511
|
7.7%
1/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
12.5%
1/8 • Baseline up to Day 2511
|
1.6%
3/184 • Baseline up to Day 2511
|
1.3%
2/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
6.0%
3/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
3.8%
2/53 • Baseline up to Day 2511
|
4.5%
2/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
3.4%
7/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
1.3%
2/153 • Baseline up to Day 2511
|
|
Cardiac disorders
Tachycardia
|
25.0%
1/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
9.5%
2/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
2.7%
5/184 • Baseline up to Day 2511
|
5.1%
8/156 • Baseline up to Day 2511
|
3.0%
5/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
2.2%
2/90 • Baseline up to Day 2511
|
9.5%
2/21 • Baseline up to Day 2511
|
5.6%
1/18 • Baseline up to Day 2511
|
6.0%
3/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
2.4%
3/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
5.8%
6/103 • Baseline up to Day 2511
|
1.5%
3/205 • Baseline up to Day 2511
|
1.5%
2/132 • Baseline up to Day 2511
|
1.3%
2/153 • Baseline up to Day 2511
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
6.7%
1/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/4 • Baseline up to Day 2511
|
7.7%
1/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
37.5%
3/8 • Baseline up to Day 2511
|
8.7%
16/184 • Baseline up to Day 2511
|
10.3%
16/156 • Baseline up to Day 2511
|
7.1%
12/168 • Baseline up to Day 2511
|
3.3%
2/60 • Baseline up to Day 2511
|
3.3%
3/90 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
16.7%
3/18 • Baseline up to Day 2511
|
22.0%
11/50 • Baseline up to Day 2511
|
5.9%
3/51 • Baseline up to Day 2511
|
7.5%
4/53 • Baseline up to Day 2511
|
6.8%
3/44 • Baseline up to Day 2511
|
8.8%
11/125 • Baseline up to Day 2511
|
11.3%
7/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
4.9%
5/103 • Baseline up to Day 2511
|
3.4%
7/205 • Baseline up to Day 2511
|
3.8%
5/132 • Baseline up to Day 2511
|
9.2%
14/153 • Baseline up to Day 2511
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
12.5%
1/8 • Baseline up to Day 2511
|
2.2%
4/184 • Baseline up to Day 2511
|
3.2%
5/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
2.2%
2/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
3.8%
2/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
4.8%
3/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
1.5%
2/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/4 • Baseline up to Day 2511
|
7.7%
1/13 • Baseline up to Day 2511
|
6.7%
1/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
4.0%
2/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
1.9%
2/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Eye disorders
Dry eye
|
0.00%
0/4 • Baseline up to Day 2511
|
7.7%
1/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.6%
3/184 • Baseline up to Day 2511
|
1.3%
2/156 • Baseline up to Day 2511
|
1.2%
2/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
5.6%
5/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
1.6%
2/125 • Baseline up to Day 2511
|
3.2%
2/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
3.9%
4/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
1.3%
2/153 • Baseline up to Day 2511
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Reproductive system and breast disorders
Adnexa uteri mass
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
12.5%
1/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Reproductive system and breast disorders
Breast tenderness
|
25.0%
1/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Reproductive system and breast disorders
Pelvic discomfort
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
25.0%
1/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
1.3%
2/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
1.9%
2/103 • Baseline up to Day 2511
|
2.0%
4/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
1.3%
2/153 • Baseline up to Day 2511
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
6.7%
1/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
6.0%
3/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
1.6%
2/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
1.9%
2/103 • Baseline up to Day 2511
|
2.4%
5/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
2.6%
4/153 • Baseline up to Day 2511
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
5.6%
1/18 • Baseline up to Day 2511
|
4.0%
2/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
6.8%
3/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
3.2%
2/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
2.4%
5/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
General disorders
Pain
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
3.8%
7/184 • Baseline up to Day 2511
|
4.5%
7/156 • Baseline up to Day 2511
|
4.2%
7/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
4.0%
2/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
5.7%
3/53 • Baseline up to Day 2511
|
6.8%
3/44 • Baseline up to Day 2511
|
4.0%
5/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
2.3%
3/132 • Baseline up to Day 2511
|
2.6%
4/153 • Baseline up to Day 2511
|
|
General disorders
Gait disturbance
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
2.7%
5/184 • Baseline up to Day 2511
|
1.3%
2/156 • Baseline up to Day 2511
|
1.2%
2/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
3.2%
2/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
3.0%
4/132 • Baseline up to Day 2511
|
1.3%
2/153 • Baseline up to Day 2511
|
|
General disorders
Axillary pain
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
2.2%
4/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
1.8%
3/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
General disorders
Catheter site pain
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.6%
3/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
2.4%
4/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
1.9%
2/103 • Baseline up to Day 2511
|
1.5%
3/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
General disorders
Feeling cold
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.6%
3/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
General disorders
Localised oedema
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.6%
3/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
2.4%
3/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
General disorders
Chest discomfort
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
3.2%
5/156 • Baseline up to Day 2511
|
2.4%
4/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
General disorders
Discomfort
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
General disorders
Early satiety
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
1.6%
2/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
1.9%
2/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
General disorders
Face oedema
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
1.5%
2/132 • Baseline up to Day 2511
|
5.2%
8/153 • Baseline up to Day 2511
|
|
General disorders
Feeling hot
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
General disorders
Nodule
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
General disorders
Temperature intolerance
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
General disorders
Adverse drug reaction
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
General disorders
Cyst
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
General disorders
Inflammation
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
General disorders
Infusion site extravasation
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
1.3%
2/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
3.2%
2/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
General disorders
Oedema
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
1.3%
2/153 • Baseline up to Day 2511
|
|
General disorders
Polyp
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
General disorders
Secretion discharge
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
General disorders
Swelling
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
General disorders
Disease progression
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
1.3%
2/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
2.3%
3/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
General disorders
Administration site extravasation
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
General disorders
Catheter site erythema
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
General disorders
General physical health deterioration
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
1.2%
2/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
2.0%
3/153 • Baseline up to Day 2511
|
|
General disorders
Injection site pain
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
General disorders
Mass
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
3.8%
2/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
General disorders
Medical device site pain
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
1.9%
2/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
General disorders
Medical device site rash
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
General disorders
Oedema due to cardiac disease
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
General disorders
Performance status decreased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
General disorders
Xerosis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
General disorders
Crying
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
General disorders
Generalised oedema
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
General disorders
Catheter site swelling
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
General disorders
Catheter site warmth
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
General disorders
Local swelling
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
General disorders
Medical device pain
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
General disorders
Thirst
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
2.7%
5/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
3.0%
5/168 • Baseline up to Day 2511
|
3.3%
2/60 • Baseline up to Day 2511
|
2.2%
2/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
4.0%
2/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
3.2%
4/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
2.9%
3/103 • Baseline up to Day 2511
|
1.5%
3/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Rhonchi
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
2.2%
4/184 • Baseline up to Day 2511
|
3.2%
5/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
10.0%
6/60 • Baseline up to Day 2511
|
13.3%
12/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
18.0%
9/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
7.5%
4/53 • Baseline up to Day 2511
|
4.5%
2/44 • Baseline up to Day 2511
|
5.6%
7/125 • Baseline up to Day 2511
|
4.8%
3/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
4.9%
5/103 • Baseline up to Day 2511
|
3.4%
7/205 • Baseline up to Day 2511
|
10.6%
14/132 • Baseline up to Day 2511
|
1.3%
2/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.6%
3/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
2.2%
2/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
3.2%
2/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
2.0%
3/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
1.9%
2/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
1.5%
2/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Coeliac disease
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
1.3%
2/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
1.3%
2/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Gingival ulceration
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
1.3%
2/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Lip oedema
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Lip swelling
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
3.3%
3/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
1.9%
3/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
5.6%
1/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
1.6%
2/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
1.5%
3/205 • Baseline up to Day 2511
|
1.5%
2/132 • Baseline up to Day 2511
|
1.3%
2/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Tongue geographic
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Tongue haemorrhage
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Tooth disorder
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
2.6%
4/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
2.2%
2/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
1.9%
2/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Anal incontinence
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Hemianopia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Gingival swelling
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Oesophageal pain
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Oral dysaesthesia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Perianal erythema
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Poor dental condition
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
1.3%
2/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
1.8%
3/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
1.2%
2/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Abdominal rigidity
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Breath odour
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Faeces hard
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Glossitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
1.5%
2/132 • Baseline up to Day 2511
|
1.3%
2/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Swollen tongue
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Tongue blistering
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
3.0%
4/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Oesophageal obstruction
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Rectal tenesmus
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Salivary gland mass
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Aptyalism
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
2.2%
2/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
4.0%
2/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
2.3%
3/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
8.7%
16/184 • Baseline up to Day 2511
|
6.4%
10/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
5.7%
3/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
2.4%
5/205 • Baseline up to Day 2511
|
1.5%
2/132 • Baseline up to Day 2511
|
7.2%
11/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
4.3%
8/184 • Baseline up to Day 2511
|
2.6%
4/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
1.5%
3/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
1.3%
2/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
3.3%
6/184 • Baseline up to Day 2511
|
2.6%
4/156 • Baseline up to Day 2511
|
1.8%
3/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
3.8%
2/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
2.0%
4/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
3.9%
6/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
2.7%
5/184 • Baseline up to Day 2511
|
3.2%
5/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
4.0%
2/50 • Baseline up to Day 2511
|
3.9%
2/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
3.2%
2/62 • Baseline up to Day 2511
|
15.0%
3/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
2.9%
6/205 • Baseline up to Day 2511
|
1.5%
2/132 • Baseline up to Day 2511
|
2.6%
4/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
2.2%
4/184 • Baseline up to Day 2511
|
3.2%
5/156 • Baseline up to Day 2511
|
2.4%
4/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
4.0%
2/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
3.2%
2/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
2.9%
6/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
1.3%
2/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.6%
3/184 • Baseline up to Day 2511
|
1.9%
3/156 • Baseline up to Day 2511
|
1.2%
2/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
1.6%
2/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
1.3%
2/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.6%
3/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
1.2%
2/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Allergic sinusitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
1.3%
2/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnoea
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary venous thrombosis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
1.3%
2/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
1.3%
2/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
3.8%
2/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
2.4%
3/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
1.3%
2/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Throat tightness
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
1.6%
2/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
1.3%
2/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
1.3%
2/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Lower respiratory tract congestion
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal pain
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
1.2%
2/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus discomfort
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Sputum discoloured
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
1.3%
2/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
2.0%
3/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal haemorrhage
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
2.2%
4/184 • Baseline up to Day 2511
|
1.3%
2/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
2.4%
3/125 • Baseline up to Day 2511
|
4.8%
3/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
1.9%
2/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.6%
3/184 • Baseline up to Day 2511
|
1.3%
2/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
1.3%
2/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Musculoskeletal and connective tissue disorders
Muscle oedema
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
5.6%
1/18 • Baseline up to Day 2511
|
4.0%
2/50 • Baseline up to Day 2511
|
3.9%
2/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
1.5%
2/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
2.6%
4/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
1.6%
2/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
2.0%
3/153 • Baseline up to Day 2511
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
1.3%
2/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
4.6%
7/153 • Baseline up to Day 2511
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
1.3%
2/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Musculoskeletal and connective tissue disorders
Hypercreatinaemia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Lichenoid keratosis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Musculoskeletal and connective tissue disorders
Kyphosis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
4.5%
2/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
1.2%
2/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Musculoskeletal and connective tissue disorders
Coccydynia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Musculoskeletal and connective tissue disorders
Joint lock
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Musculoskeletal and connective tissue disorders
Muscle atrophy
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Musculoskeletal and connective tissue disorders
Tendon disorder
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Arteritis infective
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract inflammation
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
9.8%
18/184 • Baseline up to Day 2511
|
10.9%
17/156 • Baseline up to Day 2511
|
3.6%
6/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
6.7%
6/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
8.0%
4/50 • Baseline up to Day 2511
|
11.8%
6/51 • Baseline up to Day 2511
|
11.3%
6/53 • Baseline up to Day 2511
|
9.1%
4/44 • Baseline up to Day 2511
|
7.2%
9/125 • Baseline up to Day 2511
|
8.1%
5/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
9.7%
10/103 • Baseline up to Day 2511
|
8.8%
18/205 • Baseline up to Day 2511
|
10.6%
14/132 • Baseline up to Day 2511
|
4.6%
7/153 • Baseline up to Day 2511
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
4.3%
8/184 • Baseline up to Day 2511
|
1.9%
3/156 • Baseline up to Day 2511
|
1.2%
2/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
9.5%
2/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
9.1%
4/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
8.1%
5/62 • Baseline up to Day 2511
|
15.0%
3/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
2.9%
6/205 • Baseline up to Day 2511
|
2.3%
3/132 • Baseline up to Day 2511
|
7.2%
11/153 • Baseline up to Day 2511
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
2.2%
4/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
1.3%
2/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
2.9%
3/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
1.5%
2/132 • Baseline up to Day 2511
|
1.3%
2/153 • Baseline up to Day 2511
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
1.3%
2/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
3.9%
2/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
3.3%
2/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
1.6%
2/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
1.9%
2/103 • Baseline up to Day 2511
|
2.0%
4/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
1.9%
3/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Metabolism and nutrition disorders
Steroid diabetes
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
1.3%
2/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
4.0%
2/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
4.5%
2/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Metabolism and nutrition disorders
Abnormal loss of weight
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Metabolism and nutrition disorders
Appetite disorder
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Metabolism and nutrition disorders
Hyperamylasaemia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
1.5%
2/132 • Baseline up to Day 2511
|
2.0%
3/153 • Baseline up to Day 2511
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
1.2%
2/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
1.3%
2/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
2.7%
5/184 • Baseline up to Day 2511
|
3.2%
5/156 • Baseline up to Day 2511
|
2.4%
4/168 • Baseline up to Day 2511
|
5.0%
3/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
4.0%
2/50 • Baseline up to Day 2511
|
9.8%
5/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
1.6%
2/125 • Baseline up to Day 2511
|
6.5%
4/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
1.9%
2/103 • Baseline up to Day 2511
|
2.0%
4/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
1.3%
2/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
2.7%
5/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
1.8%
3/168 • Baseline up to Day 2511
|
3.3%
2/60 • Baseline up to Day 2511
|
2.2%
2/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
3.9%
2/51 • Baseline up to Day 2511
|
3.8%
2/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
2.4%
3/125 • Baseline up to Day 2511
|
3.2%
2/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
3.9%
4/103 • Baseline up to Day 2511
|
1.5%
3/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
2.0%
3/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
2.7%
5/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
3.2%
2/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
1.5%
3/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Somnolence
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
2.7%
5/184 • Baseline up to Day 2511
|
1.9%
3/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
5.9%
3/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
6.8%
3/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
3.2%
2/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.6%
3/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
3.9%
2/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.6%
3/184 • Baseline up to Day 2511
|
1.9%
3/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.6%
3/184 • Baseline up to Day 2511
|
2.6%
4/156 • Baseline up to Day 2511
|
1.2%
2/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
2.2%
2/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
5.6%
1/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
3.9%
2/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
3.2%
4/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
15.0%
3/20 • Baseline up to Day 2511
|
2.9%
3/103 • Baseline up to Day 2511
|
2.4%
5/205 • Baseline up to Day 2511
|
3.0%
4/132 • Baseline up to Day 2511
|
1.3%
2/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.6%
3/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
1.2%
2/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
2.4%
3/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
1.9%
2/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Syncope
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.6%
3/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
1.5%
2/132 • Baseline up to Day 2511
|
1.3%
2/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Vasogenic cerebral oedema
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.6%
3/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
1.3%
2/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
1.5%
3/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Migraine
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Monoparesis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Radiculopathy
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Tremor
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
2.6%
4/156 • Baseline up to Day 2511
|
1.2%
2/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
3.8%
2/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
3.2%
4/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Aphasia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Facial paresis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Horner's syndrome
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
1.9%
3/156 • Baseline up to Day 2511
|
1.2%
2/168 • Baseline up to Day 2511
|
3.3%
2/60 • Baseline up to Day 2511
|
2.2%
2/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
4.5%
2/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
2.0%
3/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Phantom limb syndrome
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Seizure
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
1.3%
2/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Sciatica
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
1.9%
3/156 • Baseline up to Day 2511
|
1.2%
2/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
3.2%
2/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
2.9%
6/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
2.0%
3/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Ataxia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
5.6%
1/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
4.0%
2/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Hypoxic-ischaemic encephalopathy
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Intracranial aneurysm
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Monoplegia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
1.9%
3/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
1.3%
2/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Nerve compression
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Parkinson's disease
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Presyncope
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
1.2%
2/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Psychomotor skills impaired
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Taste disorder
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
3.2%
2/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
2.4%
4/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Myoclonus
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Psychomotor hyperactivity
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Tongue paralysis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Ageusia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
2.7%
5/184 • Baseline up to Day 2511
|
3.8%
6/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
3.9%
2/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
2.4%
3/125 • Baseline up to Day 2511
|
3.2%
2/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
1.9%
2/103 • Baseline up to Day 2511
|
2.9%
6/205 • Baseline up to Day 2511
|
2.3%
3/132 • Baseline up to Day 2511
|
2.6%
4/153 • Baseline up to Day 2511
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
2.2%
4/184 • Baseline up to Day 2511
|
2.6%
4/156 • Baseline up to Day 2511
|
1.2%
2/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
3.9%
2/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
1.9%
2/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
1.5%
2/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
2.2%
4/184 • Baseline up to Day 2511
|
3.8%
6/156 • Baseline up to Day 2511
|
1.2%
2/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
18.0%
9/50 • Baseline up to Day 2511
|
7.8%
4/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
4.5%
2/44 • Baseline up to Day 2511
|
1.6%
2/125 • Baseline up to Day 2511
|
12.9%
8/62 • Baseline up to Day 2511
|
10.0%
2/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
2.9%
6/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
2.6%
4/153 • Baseline up to Day 2511
|
|
Infections and infestations
Tooth infection
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
2.2%
4/184 • Baseline up to Day 2511
|
1.3%
2/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
2.0%
3/153 • Baseline up to Day 2511
|
|
Infections and infestations
Abscess limb
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Candida infection
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
2.2%
2/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Infections and infestations
Lung infection
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
3.8%
6/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
1.3%
2/153 • Baseline up to Day 2511
|
|
Infections and infestations
Asymptomatic bacteriuria
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Bacterial disease carrier
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Bacteriuria
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Chest wall abscess
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Infections and infestations
Cystitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
1.2%
2/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
2.0%
4/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Ear infection
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
5.6%
1/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Eye infection
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Fungal infection
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Furuncle
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Helicobacter infection
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Infection
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
4.0%
2/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
1.5%
2/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Influenza
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
1.3%
2/156 • Baseline up to Day 2511
|
1.2%
2/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
4.8%
3/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Infections and infestations
Lung abscess
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Nail infection
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Oral fungal infection
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Infections and infestations
Oral infection
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
1.2%
2/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
3.8%
2/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
3.2%
2/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Rash pustular
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
1.3%
2/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
4.5%
2/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
1.3%
2/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Skin candida
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Stenotrophomonas infection
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
1.3%
2/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
1.3%
2/153 • Baseline up to Day 2511
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
1.9%
2/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Vulval abscess
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
4.0%
2/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
2.4%
3/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
10.0%
2/20 • Baseline up to Day 2511
|
1.9%
2/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Cellulitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
2.6%
4/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
3.8%
2/53 • Baseline up to Day 2511
|
4.5%
2/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
1.9%
2/103 • Baseline up to Day 2511
|
2.0%
4/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
2.2%
4/184 • Baseline up to Day 2511
|
1.9%
3/156 • Baseline up to Day 2511
|
2.4%
4/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
5.6%
1/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
3.2%
2/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
3.9%
6/153 • Baseline up to Day 2511
|
|
Infections and infestations
Skin infection
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
1.9%
3/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
1.3%
2/153 • Baseline up to Day 2511
|
|
Infections and infestations
Erysipelas
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
1.3%
2/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Cystitis klebsiella
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Fungal oesophagitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
3.2%
2/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Infected dermal cyst
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Labyrinthitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Infections and infestations
Laryngitis viral
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Mycobacterial infection
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Oral herpes
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
3.8%
2/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
1.6%
2/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
1.5%
3/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Infections and infestations
Rhinitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
6.5%
4/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
3.3%
5/153 • Baseline up to Day 2511
|
|
Infections and infestations
Sputum purulent
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Viral infection
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
1.2%
2/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Angular cheilitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Infections and infestations
Bacterial rhinitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Device related infection
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Impetigo
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Infections and infestations
Tongue fungal infection
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Tracheitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Infections and infestations
Acarodermatitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
4.0%
2/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Endophthalmitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Fungal pharyngitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Gingivitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Laryngitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Lice infestation
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Periodontitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Vestibulitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
C-reactive protein increased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
2.2%
4/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
1.6%
2/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
1.9%
2/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
2.3%
3/132 • Baseline up to Day 2511
|
2.0%
3/153 • Baseline up to Day 2511
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
3.2%
2/62 • Baseline up to Day 2511
|
10.0%
2/20 • Baseline up to Day 2511
|
1.9%
2/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Breath sounds abnormal
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
1.2%
2/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
4.5%
2/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Investigations
Heart rate increased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
International normalised ratio increased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
1.2%
2/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
2.2%
2/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
3.2%
2/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
1.9%
2/103 • Baseline up to Day 2511
|
2.0%
4/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Rheumatoid factor increased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Investigations
Troponin I increased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
White blood cell count increased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
3.8%
2/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Antinuclear antibody positive
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
1.3%
2/153 • Baseline up to Day 2511
|
|
Investigations
Bacterial test positive
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Blood follicle stimulating hormone increased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
1.2%
2/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
3.9%
2/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
1.6%
2/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
10.0%
2/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Blood magnesium decreased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
3.3%
2/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
4.0%
2/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Blood uric acid increased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Cortisol increased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Electrophoresis protein abnormal
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Fibrin D dimer increased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Haematocrit decreased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Heart rate irregular
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Lymphocyte count
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Lymphocyte count increased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Mean cell volume decreased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Pulmonary physical examination abnormal
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Reticulocyte percentage increased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Transaminases increased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Troponin increased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Investigations
Urinary sediment present
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Urine leukocyte esterase positive
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
White blood cells urine positive
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Blood creatine phosphokinase decreased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Blood potassium decreased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Investigations
Electrocardiogram T wave abnormal
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Liver function test increased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Monocyte count increased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Antineutrophil cytoplasmic antibody increased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Blood iron decreased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Vitamin D decreased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
2.2%
4/184 • Baseline up to Day 2511
|
3.2%
5/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
4.0%
2/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
3.8%
2/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
4.0%
5/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
2.9%
3/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
2.3%
3/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.6%
3/184 • Baseline up to Day 2511
|
1.3%
2/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Post-thoracotomy pain syndrome
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
1.3%
2/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Incision site pain
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
3.2%
2/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
2.6%
4/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Ear injury
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Hypobarism
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
1.3%
2/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Procedural anxiety
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Radiation necrosis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Radiation pneumonitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
2.6%
4/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Eschar
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
1.3%
2/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
1.3%
2/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Burn oesophageal
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Cartilage injury
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Incision site haematoma
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
1.6%
2/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Skin wound
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
VIIth nerve injury
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Incision site complication
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Wound secretion
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
2.2%
2/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Radiation injury
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
6.0%
11/184 • Baseline up to Day 2511
|
3.2%
5/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
4.0%
2/50 • Baseline up to Day 2511
|
3.9%
2/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
1.9%
2/103 • Baseline up to Day 2511
|
3.4%
7/205 • Baseline up to Day 2511
|
3.0%
4/132 • Baseline up to Day 2511
|
3.9%
6/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
4.3%
8/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
3.6%
6/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
4.0%
2/50 • Baseline up to Day 2511
|
5.9%
3/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
6.5%
4/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
3.9%
4/103 • Baseline up to Day 2511
|
2.0%
4/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
3.9%
6/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
2.7%
5/184 • Baseline up to Day 2511
|
9.0%
14/156 • Baseline up to Day 2511
|
4.8%
8/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
4.4%
4/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
5.6%
1/18 • Baseline up to Day 2511
|
8.0%
4/50 • Baseline up to Day 2511
|
3.9%
2/51 • Baseline up to Day 2511
|
5.7%
3/53 • Baseline up to Day 2511
|
6.8%
3/44 • Baseline up to Day 2511
|
2.4%
3/125 • Baseline up to Day 2511
|
14.5%
9/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
6.8%
14/205 • Baseline up to Day 2511
|
2.3%
3/132 • Baseline up to Day 2511
|
5.2%
8/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
2.7%
5/184 • Baseline up to Day 2511
|
2.6%
4/156 • Baseline up to Day 2511
|
2.4%
4/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
7.5%
4/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
3.2%
2/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
4.9%
5/103 • Baseline up to Day 2511
|
1.5%
3/205 • Baseline up to Day 2511
|
1.5%
2/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.6%
3/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
4.0%
2/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.6%
3/184 • Baseline up to Day 2511
|
1.3%
2/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
2.0%
3/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
1.3%
2/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
3.2%
2/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
1.3%
2/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
1.8%
3/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
1.5%
3/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
3.8%
6/156 • Baseline up to Day 2511
|
1.8%
3/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
2.2%
2/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
4.5%
2/44 • Baseline up to Day 2511
|
3.2%
4/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
2.0%
4/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Anhidrosis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative generalised
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
1.9%
3/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
3.8%
2/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
2.4%
3/125 • Baseline up to Day 2511
|
4.8%
3/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
1.5%
2/132 • Baseline up to Day 2511
|
1.3%
2/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Paraneoplastic rash
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Pigmentation disorder
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
2.6%
4/156 • Baseline up to Day 2511
|
2.4%
4/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
2.2%
2/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
1.9%
3/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.6%
3/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
1.3%
2/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
1.3%
2/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
1.2%
2/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Hand dermatitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Lichen planus
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
1.2%
2/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
2.2%
2/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
3.2%
2/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
1.2%
2/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Facial wasting
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Kidney infection
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Pemphigoid
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
2.2%
2/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
3.3%
2/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Hypertrichosis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
4.3%
8/184 • Baseline up to Day 2511
|
3.2%
5/156 • Baseline up to Day 2511
|
1.8%
3/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
6.0%
3/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
1.6%
2/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
1.9%
2/103 • Baseline up to Day 2511
|
5.4%
11/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
3.9%
6/153 • Baseline up to Day 2511
|
|
Psychiatric disorders
Depression
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
2.7%
5/184 • Baseline up to Day 2511
|
5.1%
8/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
3.3%
2/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
4.0%
2/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
3.8%
2/53 • Baseline up to Day 2511
|
4.5%
2/44 • Baseline up to Day 2511
|
1.6%
2/125 • Baseline up to Day 2511
|
3.2%
2/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
1.9%
2/103 • Baseline up to Day 2511
|
3.9%
8/205 • Baseline up to Day 2511
|
1.5%
2/132 • Baseline up to Day 2511
|
3.3%
5/153 • Baseline up to Day 2511
|
|
Psychiatric disorders
Depressive symptom
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
2.2%
4/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
3.3%
3/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Psychiatric disorders
Agitation
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.6%
3/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
6.0%
3/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
2.0%
4/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
1.3%
2/153 • Baseline up to Day 2511
|
|
Psychiatric disorders
Irritability
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Psychiatric disorders
Major depression
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
1.6%
2/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Psychiatric disorders
Delirium
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Psychiatric disorders
Mood altered
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
1.3%
2/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
1.5%
3/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Psychiatric disorders
Anxiety disorder
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Psychiatric disorders
Apathy
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Psychiatric disorders
Stress
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Psychiatric disorders
Emotional distress
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Eye disorders
Blindness
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
4.9%
9/184 • Baseline up to Day 2511
|
2.6%
4/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
5.9%
3/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
1.5%
3/205 • Baseline up to Day 2511
|
1.5%
2/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
2.2%
4/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
3.3%
5/153 • Baseline up to Day 2511
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
1.2%
2/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
3.3%
2/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Blood and lymphatic system disorders
Hypothrombinaemia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Blood and lymphatic system disorders
Splenic infarction
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Blood and lymphatic system disorders
Increased tendency to bruise
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Blood and lymphatic system disorders
Lymphatic disorder
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Vascular disorders
Hot flush
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
4.3%
8/184 • Baseline up to Day 2511
|
4.5%
7/156 • Baseline up to Day 2511
|
3.0%
5/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
4.8%
6/125 • Baseline up to Day 2511
|
3.2%
2/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
2.9%
3/103 • Baseline up to Day 2511
|
2.0%
4/205 • Baseline up to Day 2511
|
2.3%
3/132 • Baseline up to Day 2511
|
1.3%
2/153 • Baseline up to Day 2511
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
2.2%
4/184 • Baseline up to Day 2511
|
2.6%
4/156 • Baseline up to Day 2511
|
1.2%
2/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
3.2%
2/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
1.5%
2/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Vascular disorders
Haematoma
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
1.3%
2/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Vascular disorders
Arterial thrombosis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Vascular disorders
Ischaemic limb pain
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Vascular disorders
Jugular vein thrombosis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
1.2%
2/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
1.9%
2/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
1.3%
2/153 • Baseline up to Day 2511
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
1.2%
2/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
1.6%
2/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
2.9%
3/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Vascular disorders
Peripheral embolism
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Vascular disorders
Brachiocephalic vein thrombosis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Vascular disorders
Subclavian vein thrombosis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Vascular disorders
Thrombosis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
3.8%
7/184 • Baseline up to Day 2511
|
1.3%
2/156 • Baseline up to Day 2511
|
1.2%
2/168 • Baseline up to Day 2511
|
3.3%
2/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
8.0%
4/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
5.7%
3/53 • Baseline up to Day 2511
|
4.5%
2/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
1.9%
2/103 • Baseline up to Day 2511
|
1.5%
3/205 • Baseline up to Day 2511
|
1.5%
2/132 • Baseline up to Day 2511
|
1.3%
2/153 • Baseline up to Day 2511
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.6%
3/184 • Baseline up to Day 2511
|
1.9%
3/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
1.5%
3/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Cardiac disorders
Palpitations
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.6%
3/184 • Baseline up to Day 2511
|
3.8%
6/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
2.9%
3/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.6%
3/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
3.8%
2/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
1.3%
2/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
1.8%
3/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
1.3%
2/153 • Baseline up to Day 2511
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Cardiac disorders
Cyanosis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Cardiac disorders
Diastolic dysfunction
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Cardiac disorders
Sinus arrhythmia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
1.3%
2/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
1.3%
2/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Cardiac disorders
Atrial tachycardia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Cardiac disorders
Bundle branch block
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Cardiac disorders
Left atrial enlargement
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Cardiac disorders
Right atrial enlargement
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
2.7%
5/184 • Baseline up to Day 2511
|
6.4%
10/156 • Baseline up to Day 2511
|
1.2%
2/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
2.2%
2/90 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
6.0%
3/50 • Baseline up to Day 2511
|
5.9%
3/51 • Baseline up to Day 2511
|
5.7%
3/53 • Baseline up to Day 2511
|
4.5%
2/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
4.8%
3/62 • Baseline up to Day 2511
|
10.0%
2/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
8.3%
17/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
2.2%
4/184 • Baseline up to Day 2511
|
3.2%
5/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
5.6%
1/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
4.5%
2/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
4.9%
10/205 • Baseline up to Day 2511
|
3.0%
4/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
1.3%
2/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
1.3%
2/153 • Baseline up to Day 2511
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
1.9%
3/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
2.4%
5/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Renal and urinary disorders
Azotaemia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Renal and urinary disorders
Costovertebral angle tenderness
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
2.2%
2/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
5.8%
6/103 • Baseline up to Day 2511
|
2.9%
6/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
1.3%
2/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
2.2%
2/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Renal and urinary disorders
Renal infarct
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
1.9%
2/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Renal and urinary disorders
Urine odour abnormal
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
1.9%
3/156 • Baseline up to Day 2511
|
1.8%
3/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
2.9%
6/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
1.9%
3/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Renal and urinary disorders
Bladder spasm
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
1.6%
2/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
2.4%
5/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
2.3%
3/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Renal and urinary disorders
Leukocyturia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Renal and urinary disorders
Urethral disorder
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Renal and urinary disorders
Urine flow decreased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Renal and urinary disorders
Incontinence
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Renal and urinary disorders
Stress urinary incontinence
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Renal and urinary disorders
Hypertonic bladder
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
4.5%
2/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
2.9%
6/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
5.6%
1/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
2.0%
4/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.6%
3/184 • Baseline up to Day 2511
|
1.3%
2/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
6.0%
3/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Endocrine disorders
Autoimmune thyroiditis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Endocrine disorders
Hypopituitarism
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Endocrine disorders
Goitre
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Endocrine disorders
Hypogonadism
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Endocrine disorders
Autoimmune hypothyroidism
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Endocrine disorders
Thyroiditis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Endocrine disorders
Adrenal mass
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Eye disorders
Vision blurred
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
3.3%
6/184 • Baseline up to Day 2511
|
2.6%
4/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
3.8%
2/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
4.8%
6/125 • Baseline up to Day 2511
|
3.2%
2/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
1.5%
2/132 • Baseline up to Day 2511
|
2.0%
3/153 • Baseline up to Day 2511
|
|
Eye disorders
Visual impairment
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
2.2%
4/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
1.3%
2/153 • Baseline up to Day 2511
|
|
Eye disorders
Diplopia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.6%
3/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
1.6%
2/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Eye disorders
Cataract
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
1.9%
2/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Eye disorders
Conjunctival oedema
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Eye disorders
Dermatochalasis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Eye disorders
Eye discharge
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Eye disorders
Eye swelling
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Eye disorders
Eyelid ptosis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Eye disorders
Glaucoma
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Eye disorders
Iritis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Eye disorders
Periorbital swelling
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
1.3%
2/153 • Baseline up to Day 2511
|
|
Eye disorders
Pinguecula
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
1.2%
2/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Eye disorders
Eye irritation
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Eye disorders
Asthenopia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Eye disorders
Ocular discomfort
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Eye disorders
Meibomian gland dysfunction
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Eye disorders
Eye pain
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
2.6%
4/153 • Baseline up to Day 2511
|
|
Eye disorders
Episcleritis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Eye disorders
Blindness unilateral
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
1.3%
2/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.6%
3/184 • Baseline up to Day 2511
|
1.3%
2/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
1.3%
2/153 • Baseline up to Day 2511
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Eye naevus
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal tract adenoma
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nasal cavity cancer
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour flare
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
1.9%
2/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
3.6%
6/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
3.9%
2/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
1.5%
3/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
2.0%
3/153 • Baseline up to Day 2511
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hair follicle tumour benign
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of bone
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lymph nodes
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to skin
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour invasion
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant ascites
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
1.9%
2/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal squamous cell carcinoma
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
1.3%
2/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Reproductive system and breast disorders
Breast mass
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Reproductive system and breast disorders
Breast haematoma
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Reproductive system and breast disorders
Breast swelling
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Reproductive system and breast disorders
Genital rash
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Reproductive system and breast disorders
Nipple pain
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Reproductive system and breast disorders
Scrotal oedema
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Reproductive system and breast disorders
Scrotal swelling
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Reproductive system and breast disorders
Testicular oedema
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
1.2%
2/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
4.8%
3/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Reproductive system and breast disorders
Genital discomfort
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Reproductive system and breast disorders
Vulvovaginal pain
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
1.2%
2/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
2.0%
4/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
1.3%
2/153 • Baseline up to Day 2511
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
3.2%
5/156 • Baseline up to Day 2511
|
1.2%
2/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
4.0%
2/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
3.2%
2/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
2.0%
3/153 • Baseline up to Day 2511
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Ear and labyrinth disorders
Deafness unilateral
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
1.3%
2/153 • Baseline up to Day 2511
|
|
Ear and labyrinth disorders
External ear inflammation
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Ear and labyrinth disorders
Middle ear inflammation
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Ear and labyrinth disorders
Ear pruritus
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Ear and labyrinth disorders
Eustachian tube dysfunction
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
1.9%
3/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
1.6%
2/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Immune system disorders
Contrast media reaction
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
1.9%
3/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Immune system disorders
Autoimmune disorder
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
5.6%
1/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Immune system disorders
Type IV hypersensitivity reaction
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Hepatobiliary disorders
Biliary dilatation
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
1.8%
3/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
1.2%
2/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Hepatobiliary disorders
Hepatic pain
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Hepatobiliary disorders
Hepatocellular injury
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
2.6%
4/153 • Baseline up to Day 2511
|
|
Product Issues
Device occlusion
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.54%
1/184 • Baseline up to Day 2511
|
1.3%
2/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
1.7%
1/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
1.9%
2/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Product Issues
Device leakage
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Product Issues
Device malfunction
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Product Issues
Thrombosis in device
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Surgical and medical procedures
Dental implantation
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.64%
1/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Surgical and medical procedures
Manual lymphatic drainage
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Surgical and medical procedures
Therapeutic procedure
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Social circumstances
Loss of personal independence in daily activities
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
1.1%
1/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Urine ketone body present
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
5.6%
1/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Blood albumin decreased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Endocrine disorders
Diabetes insipidus
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Body temperature increased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
1.5%
3/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
2.0%
3/153 • Baseline up to Day 2511
|
|
Investigations
Corneal reflex decreased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Ammonia increased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Glycosylated haemoglobin increased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Urobilinogen urine increased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Vitamin B12 decreased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Platelet count increased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
3.8%
2/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Antinuclear antibody increased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Investigations
Respiratory rate increased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Skin turgor decreased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
1.5%
3/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Streptobacillus test positive
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
General disorders
Administration site erythema
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
General disorders
Catheter site extravasation
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
General disorders
Catheter site haematoma
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
General disorders
Infusion site swelling
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
General disorders
Drug intolerance
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Noninfective sialoadenitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
5.6%
1/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Lip blister
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Anorectal discomfort
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Portal hypertensive gastropathy
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Varices oesophageal
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Gastrointestinal sounds abnormal
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Lip pain
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
1.6%
2/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
4.0%
2/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
1.9%
2/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Metabolism and nutrition disorders
Hyperphagia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
2.9%
3/103 • Baseline up to Day 2511
|
1.5%
3/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Metabolism and nutrition disorders
Iron overload
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Urostomy complication
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Face injury
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Radiation retinopathy
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Stoma site pain
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Perineal injury
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Testicular injury
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Musculoskeletal and connective tissue disorders
Finger deformity
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Musculoskeletal and connective tissue disorders
Soft tissue necrosis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Musculoskeletal and connective tissue disorders
Autoimmune myositis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Musculoskeletal and connective tissue disorders
Clubbing
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Blood and lymphatic system disorders
Anaemia of chronic disease
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Blood and lymphatic system disorders
Hyperchromasia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Akathisia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
4.8%
1/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Asterixis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Motor dysfunction
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Muscle spasticity
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
3.9%
2/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Speech disorder
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
5.6%
1/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Renal and urinary disorders
Renal pain
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Renal and urinary disorders
Bladder dilatation
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Renal and urinary disorders
Bladder trabeculation
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Dermatosis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Skin burning sensation
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
3.2%
2/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Macule
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Nail toxicity
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Cardiac disorders
Nodal arrhythmia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Cardiac disorders
Conduction disorder
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Cardiac disorders
Cardiomegaly
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopneumopathy
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
1.9%
2/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Hypopnoea
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
4.5%
2/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal plaque
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea at rest
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal swelling
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Endocrine disorders
Cushing's syndrome
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Endocrine disorders
Cushingoid
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Endocrine disorders
Hyperparathyroidism
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Endocrine disorders
Hyperparathyroidism primary
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Eye disorders
Blepharitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Eye disorders
Chalazion
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Eye disorders
Retinal drusen
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Eye disorders
Uveitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Viral rhinitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
5.6%
1/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Abscess neck
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Haemophilus infection
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Herpes virus infection
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Infections and infestations
Myringitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Folliculitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
3.9%
2/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
1.6%
2/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Body tinea
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Pulpitis dental
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Trichomoniasis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Wound infection
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
1.9%
2/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Conjunctivitis viral
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Tinea infection
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Infections and infestations
Lip infection
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Penile infection
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Perirectal abscess
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Sepsis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
4.0%
2/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
1.6%
2/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Reproductive system and breast disorders
Dyspareunia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Reproductive system and breast disorders
Haematospermia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Reproductive system and breast disorders
Varicocele
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Reproductive system and breast disorders
Oedema genital
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Vascular disorders
Aortitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Vascular disorders
Hypovolaemic shock
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Vascular disorders
Peripheral coldness
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Vascular disorders
Pallor
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Vascular disorders
Phlebitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Psychiatric disorders
Adjustment disorder with mixed anxiety and depressed mood
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenocortical carcinoma
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
3.9%
2/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to breast
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to muscle
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic malignant melanoma
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour ulceration
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
3.9%
2/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Ear and labyrinth disorders
External ear pain
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
1.5%
2/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Surgical and medical procedures
Infection prophylaxis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Psychiatric disorders
Hallucination, visual
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
1.3%
2/153 • Baseline up to Day 2511
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Psychiatric disorders
Substance-induced psychotic disorder
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Psychiatric disorders
Affective disorder
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
2.0%
1/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Psychiatric disorders
Personality change
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
1.9%
1/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Social circumstances
Pregnancy of partner
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
1.6%
2/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
1.5%
2/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
1.6%
2/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Enterocutaneous fistula
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Faeces soft
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Functional gastrointestinal disorder
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Large intestinal haemorrhage
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Noninfective gingivitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Rectal discharge
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Anal pruritus
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
3.2%
2/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
3.2%
2/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Bowel movement irregularity
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Tongue discomfort
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Mucous stools
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Autoimmune colitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Defaecation urgency
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Gingival disorder
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Lip ulceration
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Mouth cyst
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Oral disorder
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Oral mucosal blistering
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Pancreatic duct dilatation
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Gastrointestinal fistula
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Oesophageal fistula
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
2.0%
3/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Tongue oedema
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
1.3%
2/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Mouth swelling
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Regurgitation
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Salivary gland pain
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Tongue necrosis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
General disorders
Implant site pain
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
General disorders
Catheter site dermatitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
General disorders
Catheter site haemorrhage
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
General disorders
Catheter site rash
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
General disorders
Catheter site inflammation
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
General disorders
Complication associated with device
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
General disorders
Gait deviation
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
General disorders
Hernia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
General disorders
Injection site pruritus
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
General disorders
Suprapubic pain
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
General disorders
Hypothermia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
General disorders
Medical device site erythema
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Investigations
Blood sodium decreased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
1.6%
2/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Carbohydrate antigen 125 increased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Electrocardiogram ST segment abnormal
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Lymph node palpable
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Red blood cells urine positive
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Waist circumference increased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Blood urea increased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
1.5%
3/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Glomerular filtration rate increased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Reticulocyte count increased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Thyroxine decreased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Blood creatine increased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Glomerular filtration rate decreased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Occult blood positive
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Protein total decreased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
1.5%
2/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Prothrombin level increased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Sputum abnormal
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Thyroid hormones increased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Urine output decreased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Blood potassium increased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Cardiac murmur
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Blood magnesium increased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Blood testosterone decreased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Klebsiella test positive
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Transferrin increased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Transferrin saturation decreased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Amylase decreased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Blood calcium decreased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Blood chloride decreased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Investigations
Blood lactic acid increased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Investigations
Computerised tomogram thorax abnormal
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Investigations
Eastern Cooperative Oncology Group performance status worsened
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Investigations
Electrocardiogram QRS complex prolonged
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Investigations
Electrocardiogram T wave peaked
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Investigations
Rheumatoid factor quantitative increased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Genital infection female
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Anal abscess
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Bronchitis viral
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Mastitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Molluscum contagiosum
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Diarrhoea infectious
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Coccidioidomycosis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Pyuria
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Stoma site infection
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Herpes dermatitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Infected skin ulcer
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Paronychia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Pelvic abscess
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Pneumonia cytomegaloviral
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Septic shock
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Urinary tract infection enterococcal
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Urinary tract infection fungal
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Empyema
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Endocarditis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Meningitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Stoma site cellulitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Vascular device infection
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
1.3%
2/153 • Baseline up to Day 2511
|
|
Infections and infestations
Beta haemolytic streptococcal infection
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Infections and infestations
Clostridium colitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Infections and infestations
Gingival abscess
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Infections and infestations
Medical device site infection
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Infections and infestations
Ophthalmic herpes zoster
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Infections and infestations
Purulent discharge
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Infections and infestations
Upper respiratory fungal infection
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Musculoskeletal and connective tissue disorders
Joint instability
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Musculoskeletal and connective tissue disorders
Limb mass
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Musculoskeletal and connective tissue disorders
Bone cyst
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Musculoskeletal and connective tissue disorders
Crystal arthropathy
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Musculoskeletal and connective tissue disorders
Patellofemoral pain syndrome
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Musculoskeletal and connective tissue disorders
Sjogren's syndrome
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Musculoskeletal and connective tissue disorders
Fracture pain
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Melanocytic hyperplasia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Musculoskeletal and connective tissue disorders
Myosclerosis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
1.3%
2/153 • Baseline up to Day 2511
|
|
Musculoskeletal and connective tissue disorders
Bone fistula
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Musculoskeletal and connective tissue disorders
Torticollis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Metabolism and nutrition disorders
Polydipsia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Metabolism and nutrition disorders
Uraemic acidosis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Metabolism and nutrition disorders
Folate deficiency
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
1.5%
2/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary pain
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
1.6%
2/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Scar pain
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Nasal inflammation
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Allergic pharyngitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Peritumoural oedema
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Product Issues
Device material opacification
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Painful respiration
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory acidosis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Rhinalgia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Pachymeningitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Unresponsive to stimuli
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Pneumothorax traumatic
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Renal and urinary disorders
Urinary hesitation
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Renal and urinary disorders
Bladder pain
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
1.5%
3/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Renal and urinary disorders
Urethral stenosis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Renal and urinary disorders
Urge incontinence
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Renal and urinary disorders
Urine abnormality
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Endocrine disorders
Thyroid mass
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Nail dystrophy
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Nail pigmentation
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Skin toxicity
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Idiopathic guttate hypomelanosis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Onychomadesis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Granuloma skin
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Xeroderma
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Blood blister
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Skin hypertrophy
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Solar lentigo
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Febrile convulsion
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
3.2%
2/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Narcolepsy
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Sensory disturbance
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Altered state of consciousness
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Amnesia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
2.0%
4/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Apraxia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Coma
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Coordination abnormal
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Resting tremor
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Sensory loss
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Hypotonia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Aphonia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Nervous system disorders
Carotid sinus syndrome
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Stoma site haemorrhage
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Post procedural inflammation
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Lip injury
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Gastrostomy tube site complication
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Confusion postoperative
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Foreign body in eye
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Fractured sacrum
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Incision site pruritus
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Stoma site pruritus
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Suture related complication
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Bite
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Radiation associated pain
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Radiation fibrosis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Skin injury
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Injury, poisoning and procedural complications
Stoma complication
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Vascular disorders
Pelvic venous thrombosis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Vascular disorders
Phlebitis superficial
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Vascular disorders
Raynaud's phenomenon
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Vascular disorders
Hypertensive urgency
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Vascular disorders
Vasculitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Vascular disorders
Superior vena cava syndrome
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Vascular disorders
Varicose vein
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Psychiatric disorders
Mood swings
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Psychiatric disorders
Mental disorder
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Psychiatric disorders
Panic disorder
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Psychiatric disorders
Affect lability
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Renal and urinary disorders
Nephritis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Eye disorders
Anterior segment ischaemia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Eye disorders
Keratitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Eye disorders
Optic neuropathy
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Eye disorders
Periorbital pain
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Eye disorders
Photophobia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Eye disorders
Diabetic retinopathy
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Eye disorders
Eyelid skin dryness
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Eye disorders
Scleral hyperaemia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Eye disorders
Swelling of eyelid
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Eye disorders
Blepharospasm
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Eye disorders
Erythema of eyelid
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Eye disorders
Macular degeneration
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Eye disorders
Conjunctival deposit
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Eye disorders
Eye pruritus
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Eye disorders
Photopsia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Eye disorders
Charles Bonnet syndrome
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Eye disorders
Dry age-related macular degeneration
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Eye disorders
Ectropion
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Eye disorders
Exophthalmos
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Eye disorders
Noninfective conjunctivitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Blood and lymphatic system disorders
Immune thrombocytopenic purpura
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Blood and lymphatic system disorders
Neutrophilia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Blood and lymphatic system disorders
Platelet dysfunction
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Blood and lymphatic system disorders
Thrombocytopenic purpura
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Cardiac disorders
Bundle branch block right
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Cardiac disorders
Heart valve incompetence
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Cardiac disorders
Atrial thrombosis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Cardiac disorders
Bundle branch block left
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Cardiac disorders
Cardiac failure chronic
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Reproductive system and breast disorders
Penile swelling
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Reproductive system and breast disorders
Uterine atrophy
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Renal and urinary disorders
Vaginal haematoma
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Renal and urinary disorders
Ejaculation disorder
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Reproductive system and breast disorders
Sexual dysfunction
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
5.0%
1/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Reproductive system and breast disorders
Scrotal pain
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Reproductive system and breast disorders
Menopausal symptoms
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Immune system disorders
Contrast media allergy
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.80%
1/125 • Baseline up to Day 2511
|
4.8%
3/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
1.6%
1/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acrochordon
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm swelling
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of thyroid gland
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma stage 0
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spine
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic neoplasm
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Urethral cancer
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Urinary tract carcinoma in situ
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour fistulisation
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basosquamous carcinoma
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Schwannoma
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.97%
1/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Ear and labyrinth disorders
Ear swelling
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Ear and labyrinth disorders
Otorrhoea
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Hepatobiliary disorders
Ischaemic hepatitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Product Issues
Device breakage
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Product Issues
Device dislocation
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Congenital, familial and genetic disorders
Vertebral artery hypoplasia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Abscess
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.76%
1/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Actinic cheilitis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Madarosis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Nodular rash
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Cardiac disorders
Bradycardia
|
25.0%
1/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
1.1%
2/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.60%
1/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
1.9%
2/103 • Baseline up to Day 2511
|
0.98%
2/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.65%
1/153 • Baseline up to Day 2511
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
General disorders
Hyperthermia
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
2.0%
1/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Infections and infestations
Device related sepsis
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
Metabolism and nutrition disorders
Vitamin B1 deficiency
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
0.00%
0/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.49%
1/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
|
General disorders
Injection site oedema
|
0.00%
0/4 • Baseline up to Day 2511
|
0.00%
0/13 • Baseline up to Day 2511
|
0.00%
0/15 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/8 • Baseline up to Day 2511
|
0.00%
0/184 • Baseline up to Day 2511
|
0.00%
0/156 • Baseline up to Day 2511
|
0.00%
0/168 • Baseline up to Day 2511
|
0.00%
0/60 • Baseline up to Day 2511
|
0.00%
0/90 • Baseline up to Day 2511
|
0.00%
0/21 • Baseline up to Day 2511
|
0.00%
0/18 • Baseline up to Day 2511
|
0.00%
0/50 • Baseline up to Day 2511
|
0.00%
0/51 • Baseline up to Day 2511
|
0.00%
0/53 • Baseline up to Day 2511
|
2.3%
1/44 • Baseline up to Day 2511
|
0.00%
0/125 • Baseline up to Day 2511
|
0.00%
0/62 • Baseline up to Day 2511
|
0.00%
0/20 • Baseline up to Day 2511
|
0.00%
0/103 • Baseline up to Day 2511
|
0.00%
0/205 • Baseline up to Day 2511
|
0.00%
0/132 • Baseline up to Day 2511
|
0.00%
0/153 • Baseline up to Day 2511
|
Additional Information
Communication Center
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