Trial Outcomes & Findings for GEN1029 (HexaBody®-DR5/DR5) Safety Trial in Patients With Malignant Solid Tumors (NCT NCT03576131)
NCT ID: NCT03576131
Last Updated: 2023-08-01
Results Overview
DLT criteria in the dose escalation phase of this trial are defined as hematologic toxicity including Grade (G) 4 neutropenia/thrombocytopenia for minimal duration of 7 days, G3/4 febrile neutropenia, \>=G3 thrombocytopenia with bleeding, or G4 anemia; and non-hematologic toxicity including G4 infusion-related reactions (IRR) or anaphylaxis, G3 IRR did not resolve to =\<G1 within 24 hours, \>=G3 diarrhea/vomiting (did not respond to optimal treatment within 2 days), G3 nausea (did not respond to optimal treatment within 7days), or Hy's law or protocol-specified toxicities related to liver function test results or amylase and/or lipase elevations; or any \>=G3 possibly related non-hematological AE, which occurred during first 2 cycles (as specified in protocol).
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
48 participants
Primary outcome timeframe
From Day 1 to 28 days after the first dose of study drug
Results posted on
2023-08-01
Participant Flow
The sponsor decided to halt the development of GEN1029 due to a narrow therapeutic window after the dose-escalation part, hence the expansion part of the trial was not performed. Therefore, results are reported here only for the dose-escalation part.
Participant milestones
| Measure |
Biweekly Regimen (GEN1029 0.1 mg/kg)
Participants received 0.1 mg/kg of GEN1029 every 2 weeks (Q2W) until the end of treatment.
|
Biweekly Regimen (GEN1029 0.2 mg/kg)
Participants received 0.2 mg/kg of GEN1029 Q2W until the end of treatment.
|
Biweekly Regimen (GEN1029 0.3 mg/kg)
Participants received 0.3 mg/kg of GEN1029 Q2W until the end of treatment.
|
Biweekly Regimen (GEN1029 1.0 mg/kg)
Participants received 1.0 mg/kg of GEN1029 Q2W until the end of treatment.
|
Biweekly Regimen (GEN1029 2.0 mg/kg)
Participants received 2.0 mg/kg of GEN1029 Q2W until the end of treatment.
|
Biweekly Regimen (GEN1029 3.0 mg/kg)
Participants received 3.0 mg/kg of GEN1029 Q2W until the end of treatment.
|
Priming Regimen (GEN1029 0.1 mg/kg)
Participants received a priming dose of 0.1 mg/kg of GEN1029 on Cycle 1 Day 1. After 14 days and thereafter once every 14 days, participants received full dose of 0.3 mg/kg until the end of treatment.
|
Intensified Regimen (GEN1029 1.0 mg/kg)
Participants received 1.0 mg/kg of GEN1029 once a week (Q1W) for the first 8 weeks then Q2W until the end of treatment.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
7
|
4
|
11
|
7
|
7
|
1
|
1
|
|
Overall Study
COMPLETED
|
1
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
9
|
5
|
4
|
11
|
7
|
7
|
1
|
1
|
Reasons for withdrawal
| Measure |
Biweekly Regimen (GEN1029 0.1 mg/kg)
Participants received 0.1 mg/kg of GEN1029 every 2 weeks (Q2W) until the end of treatment.
|
Biweekly Regimen (GEN1029 0.2 mg/kg)
Participants received 0.2 mg/kg of GEN1029 Q2W until the end of treatment.
|
Biweekly Regimen (GEN1029 0.3 mg/kg)
Participants received 0.3 mg/kg of GEN1029 Q2W until the end of treatment.
|
Biweekly Regimen (GEN1029 1.0 mg/kg)
Participants received 1.0 mg/kg of GEN1029 Q2W until the end of treatment.
|
Biweekly Regimen (GEN1029 2.0 mg/kg)
Participants received 2.0 mg/kg of GEN1029 Q2W until the end of treatment.
|
Biweekly Regimen (GEN1029 3.0 mg/kg)
Participants received 3.0 mg/kg of GEN1029 Q2W until the end of treatment.
|
Priming Regimen (GEN1029 0.1 mg/kg)
Participants received a priming dose of 0.1 mg/kg of GEN1029 on Cycle 1 Day 1. After 14 days and thereafter once every 14 days, participants received full dose of 0.3 mg/kg until the end of treatment.
|
Intensified Regimen (GEN1029 1.0 mg/kg)
Participants received 1.0 mg/kg of GEN1029 once a week (Q1W) for the first 8 weeks then Q2W until the end of treatment.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Investigator decision
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
0
|
1
|
2
|
3
|
1
|
0
|
|
Overall Study
Death
|
3
|
3
|
1
|
5
|
4
|
1
|
0
|
1
|
|
Overall Study
New anti-cancer treatment
|
5
|
1
|
2
|
3
|
0
|
0
|
0
|
0
|
|
Overall Study
Unspecified reason
|
0
|
0
|
1
|
1
|
1
|
1
|
0
|
0
|
|
Overall Study
Subject non-compliance
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
GEN1029 (HexaBody®-DR5/DR5) Safety Trial in Patients With Malignant Solid Tumors
Baseline characteristics by cohort
| Measure |
Biweekly Regimen (GEN1029 0.1 mg/kg)
n=10 Participants
Participants received 0.1 mg/kg of GEN1029 every 2 weeks (Q2W) until the end of treatment.
|
Biweekly Regimen (GEN1029 0.2 mg/kg)
n=7 Participants
Participants received 0.2 mg/kg of GEN1029 Q2W until the end of treatment.
|
Biweekly Regimen (GEN1029 0.3 mg/kg)
n=4 Participants
Participants received 0.3 mg/kg of GEN1029 Q2W until the end of treatment.
|
Biweekly Regimen (GEN1029 1.0 mg/kg)
n=11 Participants
Participants received 1.0 mg/kg of GEN1029 Q2W until the end of treatment.
|
Biweekly Regimen (GEN1029 2.0 mg/kg)
n=7 Participants
Participants received 2.0 mg/kg of GEN1029 Q2W until the end of treatment.
|
Biweekly Regimen (GEN1029 3.0 mg/kg)
n=7 Participants
Participants received 3.0 mg/kg of GEN1029 Q2W until the end of treatment.
|
Priming Regimen (GEN1029 0.1 mg/kg)
n=1 Participants
Participants received a priming dose of 0.1 mg/kg of GEN1029 on Cycle 1 Day 1. After 14 days and thereafter once every 14 days, participants received full dose of 0.3 mg/kg until the end of treatment.
|
Intensified Regimen (GEN1029 1.0 mg/kg)
n=1 Participants
Participants received 1.0 mg/kg of GEN1029 once a week (Q1W) for the first 8 weeks then Q2W until the end of treatment.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
0 Participants
n=193 Participants
|
0 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
7 Participants
n=31 Participants
|
3 Participants
n=146 Participants
|
4 Participants
n=19 Participants
|
1 Participants
n=147 Participants
|
0 Participants
n=193 Participants
|
27 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
4 Participants
n=31 Participants
|
4 Participants
n=146 Participants
|
3 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
1 Participants
n=193 Participants
|
21 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
8 Participants
n=31 Participants
|
5 Participants
n=146 Participants
|
4 Participants
n=19 Participants
|
1 Participants
n=147 Participants
|
0 Participants
n=193 Participants
|
27 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
3 Participants
n=31 Participants
|
2 Participants
n=146 Participants
|
3 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
1 Participants
n=193 Participants
|
21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
1 Participants
n=146 Participants
|
1 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
0 Participants
n=193 Participants
|
5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
10 Participants
n=31 Participants
|
6 Participants
n=146 Participants
|
6 Participants
n=19 Participants
|
1 Participants
n=147 Participants
|
1 Participants
n=193 Participants
|
43 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
0 Participants
n=193 Participants
|
0 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
0 Participants
n=193 Participants
|
0 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
0 Participants
n=193 Participants
|
1 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
0 Participants
n=193 Participants
|
0 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
0 Participants
n=193 Participants
|
3 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
11 Participants
n=31 Participants
|
7 Participants
n=146 Participants
|
7 Participants
n=19 Participants
|
1 Participants
n=147 Participants
|
1 Participants
n=193 Participants
|
43 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
0 Participants
n=193 Participants
|
0 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
0 Participants
n=193 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: From Day 1 to 28 days after the first dose of study drugPopulation: The Dose-Determining Set (DDS) consists of all participants from the Safety Set (received at least one dose of GEN1029 and analyzed according to the actual trial treatment received) who either received between 80% and 125% of the planned dose and completed the DLT observation period (Days 1-28), or experienced a DLT during Cycle 1.
DLT criteria in the dose escalation phase of this trial are defined as hematologic toxicity including Grade (G) 4 neutropenia/thrombocytopenia for minimal duration of 7 days, G3/4 febrile neutropenia, \>=G3 thrombocytopenia with bleeding, or G4 anemia; and non-hematologic toxicity including G4 infusion-related reactions (IRR) or anaphylaxis, G3 IRR did not resolve to =\<G1 within 24 hours, \>=G3 diarrhea/vomiting (did not respond to optimal treatment within 2 days), G3 nausea (did not respond to optimal treatment within 7days), or Hy's law or protocol-specified toxicities related to liver function test results or amylase and/or lipase elevations; or any \>=G3 possibly related non-hematological AE, which occurred during first 2 cycles (as specified in protocol).
Outcome measures
| Measure |
Biweekly Regimen (GEN1029 0.1 mg/kg)
n=10 Participants
Participants received 0.1 mg/kg of GEN1029 every 2 weeks (Q2W) until the end of treatment.
|
Biweekly Regimen (GEN1029 0.2 mg/kg)
n=6 Participants
Participants received 0.2 mg/kg of GEN1029 Q2W until the end of treatment.
|
Biweekly Regimen (GEN1029 0.3 mg/kg)
n=3 Participants
Participants received 0.3 mg/kg of GEN1029 Q2W until the end of treatment.
|
Biweekly Regimen (GEN1029 1.0 mg/kg)
n=10 Participants
Participants received 1.0 mg/kg of GEN1029 Q2W until the end of treatment.
|
Biweekly Regimen (GEN1029 2.0 mg/kg)
n=7 Participants
Participants received 2.0 mg/kg of GEN1029 Q2W until the end of treatment.
|
Biweekly Regimen (GEN1029 3.0 mg/kg)
n=5 Participants
Participants received 3.0 mg/kg of GEN1029 Q2W until the end of treatment.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicities (DLTs)
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 565 (corresponding to maximum observed duration)Population: The Safety Set consists of all participants who received at least one dose of GEN1029 and analyzed according to the actual trial treatment received.
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is defined as an AE that meets one of the following criteria: fatal or life-threatening; results in persistent or significant disability/incapacity; constitutes a congenital anomaly/birth defect; medically significant (an event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the outcomes listed above \[medical and scientific judgment must be exercised in deciding whether an AE is 'medically important'\]); required inpatient hospitalization or prolongation of existing hospitalization. A TEAE is defined as an AE occurring or worsening during the treatment period including the safety follow-up period.
Outcome measures
| Measure |
Biweekly Regimen (GEN1029 0.1 mg/kg)
n=10 Participants
Participants received 0.1 mg/kg of GEN1029 every 2 weeks (Q2W) until the end of treatment.
|
Biweekly Regimen (GEN1029 0.2 mg/kg)
n=7 Participants
Participants received 0.2 mg/kg of GEN1029 Q2W until the end of treatment.
|
Biweekly Regimen (GEN1029 0.3 mg/kg)
n=4 Participants
Participants received 0.3 mg/kg of GEN1029 Q2W until the end of treatment.
|
Biweekly Regimen (GEN1029 1.0 mg/kg)
n=11 Participants
Participants received 1.0 mg/kg of GEN1029 Q2W until the end of treatment.
|
Biweekly Regimen (GEN1029 2.0 mg/kg)
n=7 Participants
Participants received 2.0 mg/kg of GEN1029 Q2W until the end of treatment.
|
Biweekly Regimen (GEN1029 3.0 mg/kg)
n=7 Participants
Participants received 3.0 mg/kg of GEN1029 Q2W until the end of treatment.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
Any TESAE
|
3 Participants
|
3 Participants
|
2 Participants
|
9 Participants
|
6 Participants
|
4 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
Any TEAE
|
8 Participants
|
7 Participants
|
4 Participants
|
11 Participants
|
7 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 565 (corresponding to maximum observed duration)Population: The Safety Set consists of all participants who received at least one dose of GEN1029 and analyzed according to the actual trial treatment received.
Number of participants with laboratory measurements of Grade \>= 3 by NCI-CTCAE v4.03 are reported. The NCI-CTCAE is a descriptive terminology is used for AE reporting. The NCI-CTCAE v4.03 displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Based on this general guideline: Grade 1 as mild AE, Grade 2 as moderate AE, Grade 3 as severe AE, Grade 4 as life-threatening or disabling AE, and Grade 5 as death. In case a participant reported multiple severity grades for an AE, only the maximum grade was used.
Outcome measures
| Measure |
Biweekly Regimen (GEN1029 0.1 mg/kg)
n=10 Participants
Participants received 0.1 mg/kg of GEN1029 every 2 weeks (Q2W) until the end of treatment.
|
Biweekly Regimen (GEN1029 0.2 mg/kg)
n=7 Participants
Participants received 0.2 mg/kg of GEN1029 Q2W until the end of treatment.
|
Biweekly Regimen (GEN1029 0.3 mg/kg)
n=4 Participants
Participants received 0.3 mg/kg of GEN1029 Q2W until the end of treatment.
|
Biweekly Regimen (GEN1029 1.0 mg/kg)
n=11 Participants
Participants received 1.0 mg/kg of GEN1029 Q2W until the end of treatment.
|
Biweekly Regimen (GEN1029 2.0 mg/kg)
n=7 Participants
Participants received 2.0 mg/kg of GEN1029 Q2W until the end of treatment.
|
Biweekly Regimen (GEN1029 3.0 mg/kg)
n=7 Participants
Participants received 3.0 mg/kg of GEN1029 Q2W until the end of treatment.
|
|---|---|---|---|---|---|---|
|
Number of Participants With >= Grade 3 Laboratory Results
Calcium decreased
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With >= Grade 3 Laboratory Results
Creatinine increased
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With >= Grade 3 Laboratory Results
Gamma-glutamyl transferase increased
|
2 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With >= Grade 3 Laboratory Results
Glucose increased
|
2 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With >= Grade 3 Laboratory Results
Hemoglobin decreased
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With >= Grade 3 Laboratory Results
Lipase increased
|
1 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With >= Grade 3 Laboratory Results
Lymphocytes decreased
|
2 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With >= Grade 3 Laboratory Results
Magnesium increased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With >= Grade 3 Laboratory Results
Prothrombin international normalized ratio - increased
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With >= Grade 3 Laboratory Results
Sodium decreased
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With >= Grade 3 Laboratory Results
Urate increased
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With >= Grade 3 Laboratory Results
Activated partial thromboplastin time prolonged
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With >= Grade 3 Laboratory Results
Alanine aminotransferase increased
|
1 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With >= Grade 3 Laboratory Results
Alkaline phosphatase increased
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With >= Grade 3 Laboratory Results
Amylase increased
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With >= Grade 3 Laboratory Results
Asparate aminotransferase increased
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With >= Grade 3 Laboratory Results
Bilirubin increased
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Predose, end of infusion, 2, 4, 24, 48, 168 and 336 hours after end of infusion on Day 1 of Cycles 1, 2, 3Population: Pharmacokinetic (PK) analysis set included all participants who were exposed to at least 1 dose of GEN1029 and who had at least 1 post-dose PK measurement. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
The Cmax of Hx-DR5-01 and Hx-DR5-05 are reported.
Outcome measures
| Measure |
Biweekly Regimen (GEN1029 0.1 mg/kg)
n=9 Participants
Participants received 0.1 mg/kg of GEN1029 every 2 weeks (Q2W) until the end of treatment.
|
Biweekly Regimen (GEN1029 0.2 mg/kg)
n=7 Participants
Participants received 0.2 mg/kg of GEN1029 Q2W until the end of treatment.
|
Biweekly Regimen (GEN1029 0.3 mg/kg)
n=4 Participants
Participants received 0.3 mg/kg of GEN1029 Q2W until the end of treatment.
|
Biweekly Regimen (GEN1029 1.0 mg/kg)
n=11 Participants
Participants received 1.0 mg/kg of GEN1029 Q2W until the end of treatment.
|
Biweekly Regimen (GEN1029 2.0 mg/kg)
n=7 Participants
Participants received 2.0 mg/kg of GEN1029 Q2W until the end of treatment.
|
Biweekly Regimen (GEN1029 3.0 mg/kg)
n=6 Participants
Participants received 3.0 mg/kg of GEN1029 Q2W until the end of treatment.
|
|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Hx-DR5-01 and Hx-DR5-05
Cmax Hx-DR5-01 Cycle 1 (Day 1)
|
0.86 µg/mL
Geometric Coefficient of Variation 36.8
|
1.90 µg/mL
Geometric Coefficient of Variation 38.0
|
2.81 µg/mL
Geometric Coefficient of Variation 28.9
|
9.79 µg/mL
Geometric Coefficient of Variation 20.9
|
21.31 µg/mL
Geometric Coefficient of Variation 24.6
|
29.75 µg/mL
Geometric Coefficient of Variation 24.9
|
|
Maximum Observed Plasma Concentration (Cmax) of Hx-DR5-01 and Hx-DR5-05
Cmax Hx-DR5-01 Cycle 2 (Day 1)
|
0.79 µg/mL
Geometric Coefficient of Variation 42.9
|
2.11 µg/mL
Geometric Coefficient of Variation 18.3
|
1.12 µg/mL
Geometric Coefficient of Variation 59.9
|
8.36 µg/mL
Geometric Coefficient of Variation 22.7
|
13.13 µg/mL
Geometric Coefficient of Variation 156.3
|
29.56 µg/mL
Geometric Coefficient of Variation 7.7
|
|
Maximum Observed Plasma Concentration (Cmax) of Hx-DR5-01 and Hx-DR5-05
Cmax Hx-DR5-01 Cycle 3 (Day 1)
|
0.89 µg/mL
Geometric Coefficient of Variation 16.6
|
1.82 µg/mL
Geometric Coefficient of Variation 53.9
|
0.89 µg/mL
Geometric Coefficient of Variation 146.4
|
7.20 µg/mL
Geometric Coefficient of Variation 11.2
|
20.35 µg/mL
Geometric Coefficient of Variation 24.7
|
28.80 µg/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
|
Maximum Observed Plasma Concentration (Cmax) of Hx-DR5-01 and Hx-DR5-05
Cmax Hx-DR5-05 Cycle 1 (Day 1)
|
0.87 µg/mL
Geometric Coefficient of Variation 45.2
|
1.81 µg/mL
Geometric Coefficient of Variation 35.7
|
2.82 µg/mL
Geometric Coefficient of Variation 31.8
|
9.72 µg/mL
Geometric Coefficient of Variation 17.0
|
20.90 µg/mL
Geometric Coefficient of Variation 21.9
|
29.44 µg/mL
Geometric Coefficient of Variation 27.9
|
|
Maximum Observed Plasma Concentration (Cmax) of Hx-DR5-01 and Hx-DR5-05
Cmax Hx-DR5-05 Cycle 2 (Day 1)
|
0.79 µg/mL
Geometric Coefficient of Variation 25.9
|
2.00 µg/mL
Geometric Coefficient of Variation 18.3
|
1.11 µg/mL
Geometric Coefficient of Variation 76.2
|
7.75 µg/mL
Geometric Coefficient of Variation 25.8
|
20.37 µg/mL
Geometric Coefficient of Variation 14.3
|
30.52 µg/mL
Geometric Coefficient of Variation 5.8
|
|
Maximum Observed Plasma Concentration (Cmax) of Hx-DR5-01 and Hx-DR5-05
Cmax Hx-DR5-05 Cycle 3 (Day 1)
|
0.87 µg/mL
Geometric Coefficient of Variation 26.6
|
1.28 µg/mL
Geometric Coefficient of Variation 93.8
|
1.62 µg/mL
Geometric Coefficient of Variation 108.2
|
6.77 µg/mL
Geometric Coefficient of Variation 20.6
|
5.27 µg/mL
Geometric Coefficient of Variation 577.8
|
28.50 µg/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
SECONDARY outcome
Timeframe: Predose, end of infusion, 2, 4, 24, 48, 168 and 336 hours after end of infusion on Day 1 of Cycles 1, 2, 3Population: PK analysis set included all participants who were exposed to at least 1 dose of GEN1029 and who had at least 1 post-dose PK measurement. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
The AUC(0-inf) of Hx-DR5-01 and Hx-DR5-05 are reported.
Outcome measures
| Measure |
Biweekly Regimen (GEN1029 0.1 mg/kg)
n=9 Participants
Participants received 0.1 mg/kg of GEN1029 every 2 weeks (Q2W) until the end of treatment.
|
Biweekly Regimen (GEN1029 0.2 mg/kg)
n=7 Participants
Participants received 0.2 mg/kg of GEN1029 Q2W until the end of treatment.
|
Biweekly Regimen (GEN1029 0.3 mg/kg)
n=4 Participants
Participants received 0.3 mg/kg of GEN1029 Q2W until the end of treatment.
|
Biweekly Regimen (GEN1029 1.0 mg/kg)
n=11 Participants
Participants received 1.0 mg/kg of GEN1029 Q2W until the end of treatment.
|
Biweekly Regimen (GEN1029 2.0 mg/kg)
n=7 Participants
Participants received 2.0 mg/kg of GEN1029 Q2W until the end of treatment.
|
Biweekly Regimen (GEN1029 3.0 mg/kg)
n=6 Participants
Participants received 3.0 mg/kg of GEN1029 Q2W until the end of treatment.
|
|---|---|---|---|---|---|---|
|
Area Under Plasma Concentration-time Curve From Time Zero to Infinity (AUC[0-inf]) of Hx-DR5-01 and Hx-DR5-05
AUC(0-inf) Hx-DR5-01 Cycle 1 Day 1
|
39.44 µg*h/mL
Geometric Coefficient of Variation 50.2
|
91.20 µg*h/mL
Geometric Coefficient of Variation 66.0
|
85.80 µg*h/mL
Geometric Coefficient of Variation 56.7
|
523.66 µg*h/mL
Geometric Coefficient of Variation 47.5
|
1298.0 µg*h/mL
Geometric Coefficient of Variation 22.7
|
1497.7 µg*h/mL
Geometric Coefficient of Variation 58.7
|
|
Area Under Plasma Concentration-time Curve From Time Zero to Infinity (AUC[0-inf]) of Hx-DR5-01 and Hx-DR5-05
AUC(0-inf) Hx-DR5-01 Cycle 2 Day 1
|
46.37 µg*h/mL
Geometric Coefficient of Variation 61.5
|
105.32 µg*h/mL
Geometric Coefficient of Variation 55.8
|
35.24 µg*h/mL
Geometric Coefficient of Variation 30.5
|
530.48 µg*h/mL
Geometric Coefficient of Variation 24.8
|
1071.5 µg*h/mL
Geometric Coefficient of Variation 30.7
|
2488.5 µg*h/mL
Geometric Coefficient of Variation 10.7
|
|
Area Under Plasma Concentration-time Curve From Time Zero to Infinity (AUC[0-inf]) of Hx-DR5-01 and Hx-DR5-05
AUC(0-inf) Hx-DR5-01 Cycle 3 Day 1
|
37.43 µg*h/mL
Geometric Coefficient of Variation 74.0
|
53.24 µg*h/mL
Geometric Coefficient of Variation 133.3
|
41.41 µg*h/mL
Geometric Coefficient of Variation 84.9
|
422.32 µg*h/mL
Geometric Coefficient of Variation 26.8
|
1097.8 µg*h/mL
Geometric Coefficient of Variation 36.6
|
2653.5 µg*h/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
|
Area Under Plasma Concentration-time Curve From Time Zero to Infinity (AUC[0-inf]) of Hx-DR5-01 and Hx-DR5-05
AUC(0-inf) Hx-DR5-05 Cycle 1 Day 1
|
32.97 µg*h/mL
Geometric Coefficient of Variation 55.4
|
71.21 µg*h/mL
Geometric Coefficient of Variation 66.9
|
83.37 µg*h/mL
Geometric Coefficient of Variation 51.7
|
508.76 µg*h/mL
Geometric Coefficient of Variation 33.0
|
1052.1 µg*h/mL
Geometric Coefficient of Variation 24.7
|
1270.0 µg*h/mL
Geometric Coefficient of Variation 60.1
|
|
Area Under Plasma Concentration-time Curve From Time Zero to Infinity (AUC[0-inf]) of Hx-DR5-01 and Hx-DR5-05
AUC(0-inf) Hx-DR5-05 Cycle 2 Day 1
|
39.31 µg*h/mL
Geometric Coefficient of Variation 65.9
|
93.11 µg*h/mL
Geometric Coefficient of Variation 66.6
|
44.76 µg*h/mL
Geometric Coefficient of Variation 184.4
|
414.90 µg*h/mL
Geometric Coefficient of Variation 24.1
|
609.90 µg*h/mL
Geometric Coefficient of Variation 55.2
|
2273.6 µg*h/mL
Geometric Coefficient of Variation 9.0
|
|
Area Under Plasma Concentration-time Curve From Time Zero to Infinity (AUC[0-inf]) of Hx-DR5-01 and Hx-DR5-05
AUC(0-inf) Hx-DR5-05 Cycle 3 Day 1
|
25.87 µg*h/mL
Geometric Coefficient of Variation 57.3
|
51.36 µg*h/mL
Geometric Coefficient of Variation 161.6
|
67.23 µg*h/mL
Geometric Coefficient of Variation 200.5
|
231.49 µg*h/mL
Geometric Coefficient of Variation 53.2
|
412.87 µg*h/mL
Geometric Coefficient of Variation 64.1
|
2398.5 µg*h/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
SECONDARY outcome
Timeframe: Predose, end of infusion, 2, 4, 24, 48, 168 and 336 hours after end of infusion on Day 1 of Cycles 1, 2, 3Population: PK analysis set included all participants who were exposed to at least 1 dose of GEN1029 and who had at least 1 post-dose PK measurement. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
The AUC(0-Clast) of Hx-DR5-01 and Hx-DR5-05 are reported.
Outcome measures
| Measure |
Biweekly Regimen (GEN1029 0.1 mg/kg)
n=9 Participants
Participants received 0.1 mg/kg of GEN1029 every 2 weeks (Q2W) until the end of treatment.
|
Biweekly Regimen (GEN1029 0.2 mg/kg)
n=7 Participants
Participants received 0.2 mg/kg of GEN1029 Q2W until the end of treatment.
|
Biweekly Regimen (GEN1029 0.3 mg/kg)
n=4 Participants
Participants received 0.3 mg/kg of GEN1029 Q2W until the end of treatment.
|
Biweekly Regimen (GEN1029 1.0 mg/kg)
n=11 Participants
Participants received 1.0 mg/kg of GEN1029 Q2W until the end of treatment.
|
Biweekly Regimen (GEN1029 2.0 mg/kg)
n=7 Participants
Participants received 2.0 mg/kg of GEN1029 Q2W until the end of treatment.
|
Biweekly Regimen (GEN1029 3.0 mg/kg)
n=6 Participants
Participants received 3.0 mg/kg of GEN1029 Q2W until the end of treatment.
|
|---|---|---|---|---|---|---|
|
Area Under Plasma Concentration-time Curve From Time Zero to the Time of Last Nonzero Concentration (AUC[0-Clast]) of Hx-DR5-01 and Hx-DR5-05
AUC(0-Clast) Hx-DR5-01 Cycle 1 Day 1
|
24.36 µg*h/mL
Geometric Coefficient of Variation 73.2
|
72.25 µg*h/mL
Geometric Coefficient of Variation 70.6
|
60.78 µg*h/mL
Geometric Coefficient of Variation 35.8
|
460.37 µg*h/mL
Geometric Coefficient of Variation 43.5
|
1173.7 µg*h/mL
Geometric Coefficient of Variation 15.6
|
1058.9 µg*h/mL
Geometric Coefficient of Variation 88.6
|
|
Area Under Plasma Concentration-time Curve From Time Zero to the Time of Last Nonzero Concentration (AUC[0-Clast]) of Hx-DR5-01 and Hx-DR5-05
AUC(0-Clast) Hx-DR5-01 Cycle 2 Day 1
|
17.34 µg*h/mL
Geometric Coefficient of Variation 141.3
|
70.33 µg*h/mL
Geometric Coefficient of Variation 66.4
|
21.85 µg*h/mL
Geometric Coefficient of Variation 36.0
|
308.74 µg*h/mL
Geometric Coefficient of Variation 66.8
|
582.57 µg*h/mL
Geometric Coefficient of Variation 84.8
|
2291.4 µg*h/mL
Geometric Coefficient of Variation 18.1
|
|
Area Under Plasma Concentration-time Curve From Time Zero to the Time of Last Nonzero Concentration (AUC[0-Clast]) of Hx-DR5-01 and Hx-DR5-05
AUC(0-Clast) Hx-DR5-01 Cycle 3 Day 1
|
22.34 µg*h/mL
Geometric Coefficient of Variation 85.9
|
35.31 µg*h/mL
Geometric Coefficient of Variation 151.4
|
6.85 µg*h/mL
Geometric Coefficient of Variation 995.0
|
385.54 µg*h/mL
Geometric Coefficient of Variation 23.7
|
986.38 µg*h/mL
Geometric Coefficient of Variation 30.1
|
2444.7 µg*h/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
|
Area Under Plasma Concentration-time Curve From Time Zero to the Time of Last Nonzero Concentration (AUC[0-Clast]) of Hx-DR5-01 and Hx-DR5-05
AUC(0-Clast) Hx-DR5-05 Cycle 1 Day 1
|
25.41 µg*h/mL
Geometric Coefficient of Variation 120.7
|
53.76 µg*h/mL
Geometric Coefficient of Variation 77.0
|
53.80 µg*h/mL
Geometric Coefficient of Variation 50.8
|
432.18 µg*h/mL
Geometric Coefficient of Variation 24.5
|
956.02 µg*h/mL
Geometric Coefficient of Variation 18.8
|
964.48 µg*h/mL
Geometric Coefficient of Variation 91.1
|
|
Area Under Plasma Concentration-time Curve From Time Zero to the Time of Last Nonzero Concentration (AUC[0-Clast]) of Hx-DR5-01 and Hx-DR5-05
AUC(0-Clast) Hx-DR5-05 Cycle 2 Day 1
|
24.85 µg*h/mL
Geometric Coefficient of Variation 119.4
|
60.75 µg*h/mL
Geometric Coefficient of Variation 76.0
|
29.17 µg*h/mL
Geometric Coefficient of Variation 165.1
|
258.67 µg*h/mL
Geometric Coefficient of Variation 60.5
|
395.50 µg*h/mL
Geometric Coefficient of Variation 62.3
|
2176.0 µg*h/mL
Geometric Coefficient of Variation 11.7
|
|
Area Under Plasma Concentration-time Curve From Time Zero to the Time of Last Nonzero Concentration (AUC[0-Clast]) of Hx-DR5-01 and Hx-DR5-05
AUC(0-Clast) Hx-DR5-05 Cycle 3 Day 1
|
20.12 µg*h/mL
Geometric Coefficient of Variation 168.7
|
16.95 µg*h/mL
Geometric Coefficient of Variation 539.4
|
43.56 µg*h/mL
Geometric Coefficient of Variation 405.4
|
158.98 µg*h/mL
Geometric Coefficient of Variation 76.4
|
52.16 µg*h/mL
Geometric Coefficient of Variation 22162.5
|
2248.1 µg*h/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
SECONDARY outcome
Timeframe: Predose, end of infusion, 2, 4, 24, 48, 168 and 336 hours after end of infusion on Day 1 of Cycles 1, 2, 3Population: PK analysis set included all participants who were exposed to at least 1 dose of GEN1029 and who had at least 1 post-dose PK measurement. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
The CL of Hx-DR5-01 and Hx-DR5-05 are reported.
Outcome measures
| Measure |
Biweekly Regimen (GEN1029 0.1 mg/kg)
n=9 Participants
Participants received 0.1 mg/kg of GEN1029 every 2 weeks (Q2W) until the end of treatment.
|
Biweekly Regimen (GEN1029 0.2 mg/kg)
n=7 Participants
Participants received 0.2 mg/kg of GEN1029 Q2W until the end of treatment.
|
Biweekly Regimen (GEN1029 0.3 mg/kg)
n=4 Participants
Participants received 0.3 mg/kg of GEN1029 Q2W until the end of treatment.
|
Biweekly Regimen (GEN1029 1.0 mg/kg)
n=11 Participants
Participants received 1.0 mg/kg of GEN1029 Q2W until the end of treatment.
|
Biweekly Regimen (GEN1029 2.0 mg/kg)
n=7 Participants
Participants received 2.0 mg/kg of GEN1029 Q2W until the end of treatment.
|
Biweekly Regimen (GEN1029 3.0 mg/kg)
n=6 Participants
Participants received 3.0 mg/kg of GEN1029 Q2W until the end of treatment.
|
|---|---|---|---|---|---|---|
|
Total Clearance (CL) of Hx-DR5-01 and Hx-DR5-05
CL Hx-DR5-01 Cycle 1 Day 1
|
95.98 mL/h
Geometric Coefficient of Variation 53.8
|
91.27 mL/h
Geometric Coefficient of Variation 51.4
|
123.75 mL/h
Geometric Coefficient of Variation 69.9
|
65.36 mL/h
Geometric Coefficient of Variation 56.5
|
59.07 mL/h
Geometric Coefficient of Variation 31.4
|
69.50 mL/h
Geometric Coefficient of Variation 51.0
|
|
Total Clearance (CL) of Hx-DR5-01 and Hx-DR5-05
CL Hx-DR5-01 Cycle 2 Day 1
|
77.36 mL/h
Geometric Coefficient of Variation 70.2
|
79.97 mL/h
Geometric Coefficient of Variation 51.8
|
155.76 mL/h
Geometric Coefficient of Variation 72.6
|
58.07 mL/h
Geometric Coefficient of Variation 31.8
|
73.43 mL/h
Geometric Coefficient of Variation 28.0
|
36.92 mL/h
Geometric Coefficient of Variation 2.0
|
|
Total Clearance (CL) of Hx-DR5-01 and Hx-DR5-05
CL Hx-DR5-01 Cycle 3 Day 1
|
99.53 mL/h
Geometric Coefficient of Variation 57.1
|
131.46 mL/h
Geometric Coefficient of Variation 76.0
|
111.33 mL/h
Geometric Coefficient of Variation 12.9
|
62.90 mL/h
Geometric Coefficient of Variation 42.5
|
62.64 mL/h
Geometric Coefficient of Variation 26.1
|
37.87 mL/h
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
|
Total Clearance (CL) of Hx-DR5-01 and Hx-DR5-05
CL Hx-DR5-05 Cycle 1 Day 1
|
111.10 mL/h
Geometric Coefficient of Variation 62.5
|
116.89 mL/h
Geometric Coefficient of Variation 51.3
|
127.35 mL/h
Geometric Coefficient of Variation 69.3
|
67.28 mL/h
Geometric Coefficient of Variation 37.4
|
69.39 mL/h
Geometric Coefficient of Variation 29.2
|
81.96 mL/h
Geometric Coefficient of Variation 53.9
|
|
Total Clearance (CL) of Hx-DR5-01 and Hx-DR5-05
CL Hx-DR5-05 Cycle 2 Day 1
|
90.18 mL/h
Geometric Coefficient of Variation 69.4
|
90.45 mL/h
Geometric Coefficient of Variation 67.1
|
131.51 mL/h
Geometric Coefficient of Variation 240.7
|
79.72 mL/h
Geometric Coefficient of Variation 28.8
|
134.11 mL/h
Geometric Coefficient of Variation 51.9
|
40.41 mL/h
Geometric Coefficient of Variation 3.7
|
|
Total Clearance (CL) of Hx-DR5-01 and Hx-DR5-05
CL Hx-DR5-05 Cycle 3 Day 1
|
143.09 mL/h
Geometric Coefficient of Variation 50.5
|
140.38 mL/h
Geometric Coefficient of Variation 77.3
|
68.57 mL/h
Geometric Coefficient of Variation 42.2
|
114.74 mL/h
Geometric Coefficient of Variation 59.8
|
172.66 mL/h
Geometric Coefficient of Variation 78.9
|
41.90 mL/h
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
SECONDARY outcome
Timeframe: Predose, end of infusion, 2, 4, 24, 48, 168 and 336 hours after end of infusion on Day 1 of Cycles 1, 2, 3Population: PK analysis set included all participants who were exposed to at least 1 dose of GEN1029 and who had at least 1 post-dose PK measurement. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
The Vss of Hx-DR5-01 and Hx-DR5-05 are reported.
Outcome measures
| Measure |
Biweekly Regimen (GEN1029 0.1 mg/kg)
n=9 Participants
Participants received 0.1 mg/kg of GEN1029 every 2 weeks (Q2W) until the end of treatment.
|
Biweekly Regimen (GEN1029 0.2 mg/kg)
n=7 Participants
Participants received 0.2 mg/kg of GEN1029 Q2W until the end of treatment.
|
Biweekly Regimen (GEN1029 0.3 mg/kg)
n=4 Participants
Participants received 0.3 mg/kg of GEN1029 Q2W until the end of treatment.
|
Biweekly Regimen (GEN1029 1.0 mg/kg)
n=11 Participants
Participants received 1.0 mg/kg of GEN1029 Q2W until the end of treatment.
|
Biweekly Regimen (GEN1029 2.0 mg/kg)
n=7 Participants
Participants received 2.0 mg/kg of GEN1029 Q2W until the end of treatment.
|
Biweekly Regimen (GEN1029 3.0 mg/kg)
n=6 Participants
Participants received 3.0 mg/kg of GEN1029 Q2W until the end of treatment.
|
|---|---|---|---|---|---|---|
|
Volume of Distribution (Vss) at Steady State of Hx-DR5-01 and Hx-DR5-05
Vss Hx-DR5-01 Cycle 1 Day 1
|
5366.8 mL
Geometric Coefficient of Variation 35.0
|
4788.6 mL
Geometric Coefficient of Variation 5.0
|
3666.8 mL
Geometric Coefficient of Variation 49.4
|
3834.6 mL
Geometric Coefficient of Variation 34.3
|
4885.9 mL
Geometric Coefficient of Variation 18.8
|
4127.3 mL
Geometric Coefficient of Variation 19.2
|
|
Volume of Distribution (Vss) at Steady State of Hx-DR5-01 and Hx-DR5-05
Vss Hx-DR5-01 Cycle 2 Day 1
|
4720.0 mL
Geometric Coefficient of Variation 34.9
|
4287.5 mL
Geometric Coefficient of Variation 10.5
|
5283.0 mL
Geometric Coefficient of Variation 62.0
|
3998.1 mL
Geometric Coefficient of Variation 24.0
|
4185.8 mL
Geometric Coefficient of Variation 17.3
|
3427.5 mL
Geometric Coefficient of Variation 25.1
|
|
Volume of Distribution (Vss) at Steady State of Hx-DR5-01 and Hx-DR5-05
Vss Hx-DR5-01 Cycle 3 Day 1
|
4622.7 mL
Geometric Coefficient of Variation 31.1
|
4531.9 mL
Geometric Coefficient of Variation 6.7
|
3243.6 mL
Geometric Coefficient of Variation 14.3
|
4075.3 mL
Geometric Coefficient of Variation 26.2
|
4227.1 mL
Geometric Coefficient of Variation 8.7
|
4118.5 mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
|
Volume of Distribution (Vss) at Steady State of Hx-DR5-01 and Hx-DR5-05
Vss Hx-DR5-05 Cycle 1 Day 1
|
4722.7 mL
Geometric Coefficient of Variation 55.6
|
5242.9 mL
Geometric Coefficient of Variation 15.8
|
3942.4 mL
Geometric Coefficient of Variation 63.6
|
3611.0 mL
Geometric Coefficient of Variation 26.5
|
4291.6 mL
Geometric Coefficient of Variation 9.8
|
4142.9 mL
Geometric Coefficient of Variation 21.0
|
|
Volume of Distribution (Vss) at Steady State of Hx-DR5-01 and Hx-DR5-05
Vss Hx-DR5-05 Cycle 2 Day 1
|
4899.3 mL
Geometric Coefficient of Variation 22.7
|
4701.6 mL
Geometric Coefficient of Variation 15.0
|
5177.9 mL
Geometric Coefficient of Variation 100.6
|
4054.4 mL
Geometric Coefficient of Variation 16.4
|
4334.9 mL
Geometric Coefficient of Variation 14.9
|
3187.8 mL
Geometric Coefficient of Variation 41.0
|
|
Volume of Distribution (Vss) at Steady State of Hx-DR5-01 and Hx-DR5-05
Vss Hx-DR5-05 Cycle 3 Day 1
|
4812.5 mL
Geometric Coefficient of Variation 31.9
|
5077.6 mL
Geometric Coefficient of Variation 24.1
|
3577.1 mL
Geometric Coefficient of Variation 15.7
|
4951.2 mL
Geometric Coefficient of Variation 42.4
|
5130.8 mL
Geometric Coefficient of Variation 5.6
|
4173.9 mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
SECONDARY outcome
Timeframe: Predose, end of infusion, 2, 4, 24, 48, 168 and 336 hours after end of infusion on Day 1 of Cycles 1, 2, 3Population: PK analysis set included all participants who were exposed to at least 1 dose of GEN1029 and who had at least 1 post-dose PK measurement. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
The t1/2 of Hx-DR5-01 and Hx-DR5-05 are reported.
Outcome measures
| Measure |
Biweekly Regimen (GEN1029 0.1 mg/kg)
n=9 Participants
Participants received 0.1 mg/kg of GEN1029 every 2 weeks (Q2W) until the end of treatment.
|
Biweekly Regimen (GEN1029 0.2 mg/kg)
n=7 Participants
Participants received 0.2 mg/kg of GEN1029 Q2W until the end of treatment.
|
Biweekly Regimen (GEN1029 0.3 mg/kg)
n=4 Participants
Participants received 0.3 mg/kg of GEN1029 Q2W until the end of treatment.
|
Biweekly Regimen (GEN1029 1.0 mg/kg)
n=11 Participants
Participants received 1.0 mg/kg of GEN1029 Q2W until the end of treatment.
|
Biweekly Regimen (GEN1029 2.0 mg/kg)
n=7 Participants
Participants received 2.0 mg/kg of GEN1029 Q2W until the end of treatment.
|
Biweekly Regimen (GEN1029 3.0 mg/kg)
n=6 Participants
Participants received 3.0 mg/kg of GEN1029 Q2W until the end of treatment.
|
|---|---|---|---|---|---|---|
|
Half-life Lambda-z (t1/2) of Hx-DR5-01 and Hx-DR5-05
T1/2 Hx-DR5-01 Cycle 1 Day 1
|
41.69 h
Interval 20.7 to 61.1
|
41.31 h
Interval 16.6 to 60.3
|
18.10 h
Interval 11.4 to 40.5
|
40.27 h
Interval 5.1 to 66.8
|
70.90 h
Interval 50.5 to 86.2
|
42.45 h
Interval 17.9 to 80.5
|
|
Half-life Lambda-z (t1/2) of Hx-DR5-01 and Hx-DR5-05
T1/2 Hx-DR5-01 Cycle 2 Day 1
|
37.75 h
Interval 29.1 to 72.3
|
39.57 h
Interval 21.7 to 62.5
|
24.47 h
Interval 16.9 to 29.7
|
49.64 h
Interval 36.2 to 71.5
|
33.62 h
Interval 29.0 to 88.2
|
65.85 h
Interval 54.6 to 77.1
|
|
Half-life Lambda-z (t1/2) of Hx-DR5-01 and Hx-DR5-05
T1/2 Hx-DR5-01 Cycle 3 Day 1
|
27.64 h
Interval 16.2 to 84.1
|
19.93 h
Interval 13.1 to 66.9
|
20.16 h
Interval 16.2 to 24.1
|
47.86 h
Interval 30.8 to 60.0
|
44.51 h
Interval 40.1 to 64.0
|
77.00 h
Interval 77.0 to 77.0
|
|
Half-life Lambda-z (t1/2) of Hx-DR5-01 and Hx-DR5-05
T1/2 Hx-DR5-05 Cycle 1 Day 1
|
35.55 h
Interval 12.5 to 46.5
|
34.50 h
Interval 15.6 to 52.5
|
19.10 h
Interval 14.6 to 44.0
|
36.33 h
Interval 26.4 to 70.6
|
42.68 h
Interval 35.3 to 68.8
|
37.71 h
Interval 16.6 to 69.6
|
|
Half-life Lambda-z (t1/2) of Hx-DR5-01 and Hx-DR5-05
T1/2 Hx-DR5-05 Cycle 2 Day 1
|
32.46 h
Interval 19.3 to 71.4
|
37.71 h
Interval 17.3 to 80.7
|
25.43 h
Interval 13.9 to 62.3
|
37.69 h
Interval 28.4 to 43.5
|
26.68 h
Interval 13.1 to 29.4
|
51.97 h
Interval 30.8 to 73.1
|
|
Half-life Lambda-z (t1/2) of Hx-DR5-01 and Hx-DR5-05
T1/2 Hx-DR5-05 Cycle 3 Day 1
|
25.30 h
Interval 12.0 to 39.6
|
18.75 h
Interval 15.4 to 57.4
|
41.26 h
Interval 24.3 to 58.2
|
33.90 h
Interval 14.2 to 62.1
|
22.83 h
Interval 13.2 to 32.5
|
70.9 h
Interval 70.9 to 70.9
|
SECONDARY outcome
Timeframe: Predose, end of infusion, 2, 4, 24, 48, 168 and 336 hours after end of infusion on Day 1 of Cycles 1, 2, 3Population: PK analysis set included all participants who were exposed to at least 1 dose of GEN1029 and who had at least 1 post-dose PK measurement. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
The Tmax of Hx-DR5-01 and Hx-DR5-05 are reported.
Outcome measures
| Measure |
Biweekly Regimen (GEN1029 0.1 mg/kg)
n=9 Participants
Participants received 0.1 mg/kg of GEN1029 every 2 weeks (Q2W) until the end of treatment.
|
Biweekly Regimen (GEN1029 0.2 mg/kg)
n=7 Participants
Participants received 0.2 mg/kg of GEN1029 Q2W until the end of treatment.
|
Biweekly Regimen (GEN1029 0.3 mg/kg)
n=4 Participants
Participants received 0.3 mg/kg of GEN1029 Q2W until the end of treatment.
|
Biweekly Regimen (GEN1029 1.0 mg/kg)
n=11 Participants
Participants received 1.0 mg/kg of GEN1029 Q2W until the end of treatment.
|
Biweekly Regimen (GEN1029 2.0 mg/kg)
n=7 Participants
Participants received 2.0 mg/kg of GEN1029 Q2W until the end of treatment.
|
Biweekly Regimen (GEN1029 3.0 mg/kg)
n=6 Participants
Participants received 3.0 mg/kg of GEN1029 Q2W until the end of treatment.
|
|---|---|---|---|---|---|---|
|
Time to Reach Maximum Observed Concentration (Tmax) of Hx-DR5-01 and Hx-DR5-05
Tmax Hx-DR5-01 Cycle 1 Day 1
|
1.58 h
Interval 1.1 to 5.8
|
1.89 h
Interval 1.4 to 5.0
|
1.23 h
Interval 1.2 to 1.4
|
2.00 h
Interval 0.1 to 4.7
|
1.30 h
Interval 1.1 to 3.6
|
1.46 h
Interval 1.0 to 3.1
|
|
Time to Reach Maximum Observed Concentration (Tmax) of Hx-DR5-01 and Hx-DR5-05
Tmax Hx-DR5-01 Cycle 2 Day 1
|
1.25 h
Interval 1.0 to 3.2
|
3.03 h
Interval 3.0 to 5.2
|
1.30 h
Interval 1.1 to 3.2
|
3.06 h
Interval 1.1 to 5.1
|
3.25 h
Interval 1.1 to 163.7
|
1.11 h
Interval 1.0 to 1.2
|
|
Time to Reach Maximum Observed Concentration (Tmax) of Hx-DR5-01 and Hx-DR5-05
Tmax Hx-DR5-01 Cycle 3 Day 1
|
1.08 h
Interval 0.0 to 3.4
|
1.48 h
Interval 1.0 to 2.1
|
1.13 h
Interval 1.1 to 1.3
|
3.08 h
Interval 1.4 to 3.5
|
1.82 h
Interval 1.1 to 3.2
|
3.1 h
Interval 3.1 to 3.1
|
|
Time to Reach Maximum Observed Concentration (Tmax) of Hx-DR5-01 and Hx-DR5-05
Tmax Hx-DR5-05 Cycle 1 Day 1
|
1.75 h
Interval 1.1 to 5.4
|
2.53 h
Interval 1.0 to 4.8
|
2.36 h
Interval 1.2 to 5.5
|
1.60 h
Interval 0.1 to 4.7
|
1.35 h
Interval 1.1 to 3.0
|
1.46 h
Interval 1.0 to 3.1
|
|
Time to Reach Maximum Observed Concentration (Tmax) of Hx-DR5-01 and Hx-DR5-05
Tmax Hx-DR5-05 Cycle 2 Day 1
|
3.12 h
Interval 1.1 to 5.1
|
2.19 h
Interval 1.0 to 3.5
|
1.19 h
Interval 1.0 to 1.4
|
2.26 h
Interval 1.2 to 5.1
|
2.31 h
Interval 1.1 to 3.3
|
2.21 h
Interval 1.2 to 3.2
|
|
Time to Reach Maximum Observed Concentration (Tmax) of Hx-DR5-01 and Hx-DR5-05
Tmax Hx-DR5-05 Cycle 3 Day 1
|
1.08 h
Interval 0.0 to 1.5
|
1.83 h
Interval 1.0 to 3.3
|
1.18 h
Interval 1.1 to 1.3
|
1.42 h
Interval 1.1 to 3.0
|
1.13 h
Interval 1.0 to 1.8
|
3.1 h
Interval 3.1 to 3.1
|
SECONDARY outcome
Timeframe: Predose, end of infusion, 2, 4, 24, 48, 168 and 336 hours after end of infusion on Day 1 of Cycles 1, 2, 3Population: PK analysis set included all participants who were exposed to at least 1 dose of GEN1029 and who had at least 1 post-dose PK measurement. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
The plasma concentration of Hx-DR5-01 and Hx-DR5-05 are reported.
Outcome measures
| Measure |
Biweekly Regimen (GEN1029 0.1 mg/kg)
n=9 Participants
Participants received 0.1 mg/kg of GEN1029 every 2 weeks (Q2W) until the end of treatment.
|
Biweekly Regimen (GEN1029 0.2 mg/kg)
n=7 Participants
Participants received 0.2 mg/kg of GEN1029 Q2W until the end of treatment.
|
Biweekly Regimen (GEN1029 0.3 mg/kg)
n=4 Participants
Participants received 0.3 mg/kg of GEN1029 Q2W until the end of treatment.
|
Biweekly Regimen (GEN1029 1.0 mg/kg)
n=11 Participants
Participants received 1.0 mg/kg of GEN1029 Q2W until the end of treatment.
|
Biweekly Regimen (GEN1029 2.0 mg/kg)
n=7 Participants
Participants received 2.0 mg/kg of GEN1029 Q2W until the end of treatment.
|
Biweekly Regimen (GEN1029 3.0 mg/kg)
n=6 Participants
Participants received 3.0 mg/kg of GEN1029 Q2W until the end of treatment.
|
|---|---|---|---|---|---|---|
|
Plasma Concentration of Hx-DR5-01 and Hx-DR5-05
Plasma concentration Hx-DR5-01 Cycle 1 Day 1 (predose)
|
0.085 µg/mL
Geometric Coefficient of Variation 38.5
|
0.075 µg/mL
Geometric Coefficient of Variation 0.0
|
0.075 µg/mL
Geometric Coefficient of Variation 0.0
|
0.075 µg/mL
Geometric Coefficient of Variation 0.0
|
0.075 µg/mL
Geometric Coefficient of Variation 0.0
|
0.075 µg/mL
Geometric Coefficient of Variation 0.0
|
|
Plasma Concentration of Hx-DR5-01 and Hx-DR5-05
Plasma concentration Hx-DR5-01 Cycle 2 Day 1 (predose)
|
0.091 µg/mL
Geometric Coefficient of Variation 61.0
|
0.075 µg/mL
Geometric Coefficient of Variation 0.0
|
0.075 µg/mL
Geometric Coefficient of Variation 0.0
|
0.084 µg/mL
Geometric Coefficient of Variation 34.0
|
0.230 µg/mL
Geometric Coefficient of Variation 77.8
|
0.283 µg/mL
Geometric Coefficient of Variation 576.2
|
|
Plasma Concentration of Hx-DR5-01 and Hx-DR5-05
Plasma concentration Hx-DR5-01 Cycle 3 Day 1 (predose)
|
0.075 µg/mL
Geometric Coefficient of Variation 0.0
|
0.125 µg/mL
Geometric Coefficient of Variation 164.3
|
0.075 µg/mL
Geometric Coefficient of Variation 0.0
|
0.090 µg/mL
Geometric Coefficient of Variation 46.4
|
0.224 µg/mL
Geometric Coefficient of Variation 156.9
|
0.739 µg/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
|
Plasma Concentration of Hx-DR5-01 and Hx-DR5-05
Plasma concentration Hx-DR5-05 Cycle 1 Day 1 (predose)
|
0.094 µg/mL
Geometric Coefficient of Variation 77.6
|
0.075 µg/mL
Geometric Coefficient of Variation 0.0
|
0.075 µg/mL
Geometric Coefficient of Variation 0.0
|
0.075 µg/mL
Geometric Coefficient of Variation 0.0
|
0.075 µg/mL
Geometric Coefficient of Variation 0.0
|
0.075 µg/mL
Geometric Coefficient of Variation 0.0
|
|
Plasma Concentration of Hx-DR5-01 and Hx-DR5-05
Plasma concentration Hx-DR5-05 Cycle 2 Day 1 (predose)
|
0.097 µg/mL
Geometric Coefficient of Variation 83.6
|
0.075 µg/mL
Geometric Coefficient of Variation 0.0
|
0.075 µg/mL
Geometric Coefficient of Variation 0.0
|
0.075 µg/mL
Geometric Coefficient of Variation 0.0
|
0.155 µg/mL
Geometric Coefficient of Variation 161.5
|
0.240 µg/mL
Geometric Coefficient of Variation 372.5
|
|
Plasma Concentration of Hx-DR5-01 and Hx-DR5-05
Plasma concentration Hx-DR5-05 Cycle 3 Day 1 (predose)
|
0.101 µg/mL
Geometric Coefficient of Variation 94.6
|
0.119 µg/mL
Geometric Coefficient of Variation 138.5
|
0.075 µg/mL
Geometric Coefficient of Variation 0.0
|
0.094 µg/mL
Geometric Coefficient of Variation 58.8
|
0.075 µg/mL
Geometric Coefficient of Variation 0.0
|
0.568 µg/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
SECONDARY outcome
Timeframe: From Screening (Day -21 to -1) through Day 478 (corresponding to maximum observed duration)Population: The Immunogenicity Set consists of all participants who received at least one dose of GEN1029 and analyzed according to the actual treatment received and had at least one immunogenicity measurement taken.
From positive ADA samples titer values and neutralizing antibody scores (positive or negative) were determined and reported. A participant was considered positive if negative at baseline (screening) and had at least one positive post-baseline result, or positive at baseline and had at least one positive post-baseline result with a titer higher than baseline. Number of participants with ADA positive to GEN1029 are reported.
Outcome measures
| Measure |
Biweekly Regimen (GEN1029 0.1 mg/kg)
n=10 Participants
Participants received 0.1 mg/kg of GEN1029 every 2 weeks (Q2W) until the end of treatment.
|
Biweekly Regimen (GEN1029 0.2 mg/kg)
n=7 Participants
Participants received 0.2 mg/kg of GEN1029 Q2W until the end of treatment.
|
Biweekly Regimen (GEN1029 0.3 mg/kg)
n=4 Participants
Participants received 0.3 mg/kg of GEN1029 Q2W until the end of treatment.
|
Biweekly Regimen (GEN1029 1.0 mg/kg)
n=11 Participants
Participants received 1.0 mg/kg of GEN1029 Q2W until the end of treatment.
|
Biweekly Regimen (GEN1029 2.0 mg/kg)
n=7 Participants
Participants received 2.0 mg/kg of GEN1029 Q2W until the end of treatment.
|
Biweekly Regimen (GEN1029 3.0 mg/kg)
n=7 Participants
Participants received 3.0 mg/kg of GEN1029 Q2W until the end of treatment.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Antidrug Antibodies (ADAs) Positive to GEN1029
|
5 Participants
|
5 Participants
|
4 Participants
|
7 Participants
|
5 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Baseline (Day 1) through 8.8 months (corresponding to maximum observed duration)Population: Full analysis set included all participants who received at least one dose of GEN1029 and were analyzed according to the actual treatment received.
Anti-tumor activity measured by tumor shrinkage was evaluated on based on of sum of the diameter(s) of all target lesions from the computerized tomography (CT) scan/positron emission tomography (PET)-CT scan. Largest tumor shrinkage is reported.
Outcome measures
| Measure |
Biweekly Regimen (GEN1029 0.1 mg/kg)
n=9 Participants
Participants received 0.1 mg/kg of GEN1029 every 2 weeks (Q2W) until the end of treatment.
|
Biweekly Regimen (GEN1029 0.2 mg/kg)
n=7 Participants
Participants received 0.2 mg/kg of GEN1029 Q2W until the end of treatment.
|
Biweekly Regimen (GEN1029 0.3 mg/kg)
n=4 Participants
Participants received 0.3 mg/kg of GEN1029 Q2W until the end of treatment.
|
Biweekly Regimen (GEN1029 1.0 mg/kg)
n=10 Participants
Participants received 1.0 mg/kg of GEN1029 Q2W until the end of treatment.
|
Biweekly Regimen (GEN1029 2.0 mg/kg)
n=7 Participants
Participants received 2.0 mg/kg of GEN1029 Q2W until the end of treatment.
|
Biweekly Regimen (GEN1029 3.0 mg/kg)
n=4 Participants
Participants received 3.0 mg/kg of GEN1029 Q2W until the end of treatment.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Anti-tumor Activity Measured by Tumor Shrinkage
|
12.0 millimeter
Standard Deviation 11.843
|
12.0 millimeter
Standard Deviation 17.616
|
13.75 millimeter
Standard Deviation 9.032
|
1.10 millimeter
Standard Deviation 9.049
|
9.0 millimeter
Standard Deviation 10.909
|
15.50 millimeter
Standard Deviation 18.574
|
SECONDARY outcome
Timeframe: From Day 1 through 8.8 months (corresponding to maximum observed duration)Population: Full analysis set included all participants who received at least one dose of GEN1029 and were analyzed according to the actual trial treatment received.
The radiological evaluation was based on RECIST v1.1 using CT scan/PET-CT scan. The OR was defined as complete response (CR) or partial response (PR) per RECIST v1.1. The CR was defined as disappearance of all target and non-target lesions and reduction in short axis to \<10 mm of any pathological and non-pathological lymph nodes. The PR was defined as \>=30% decrease in sum of diameters of target lesions (compared to baseline), no unequivocal progression of existing non-target lesions, and no new lesion.
Outcome measures
| Measure |
Biweekly Regimen (GEN1029 0.1 mg/kg)
n=10 Participants
Participants received 0.1 mg/kg of GEN1029 every 2 weeks (Q2W) until the end of treatment.
|
Biweekly Regimen (GEN1029 0.2 mg/kg)
n=7 Participants
Participants received 0.2 mg/kg of GEN1029 Q2W until the end of treatment.
|
Biweekly Regimen (GEN1029 0.3 mg/kg)
n=4 Participants
Participants received 0.3 mg/kg of GEN1029 Q2W until the end of treatment.
|
Biweekly Regimen (GEN1029 1.0 mg/kg)
n=11 Participants
Participants received 1.0 mg/kg of GEN1029 Q2W until the end of treatment.
|
Biweekly Regimen (GEN1029 2.0 mg/kg)
n=7 Participants
Participants received 2.0 mg/kg of GEN1029 Q2W until the end of treatment.
|
Biweekly Regimen (GEN1029 3.0 mg/kg)
n=7 Participants
Participants received 3.0 mg/kg of GEN1029 Q2W until the end of treatment.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Day 1 through 8.8 months (corresponding to maximum observed duration)Population: Full analysis set included all participants who received at least one dose of GEN1029 and were analyzed according to the actual trial treatment received.
The PFS was defined as the number of days from the date of first study drug administration to first progressive disease (PD) or death from any cause. The PD was defined as at least 20% (and \>= 5 mm) increase in the sum of the longest diameter (LD) of target lesions, compared to the smallest sum of the target LDs recorded while in trial or the appearance of 1 or more new lesions; unequivocal progression of existing non-target lesions; and/or new lesion. The radiological evaluation based on RECIST v1.1 was assessed using CT scan/PET scan. The PFS was estimated using Kaplan-Meier method.
Outcome measures
| Measure |
Biweekly Regimen (GEN1029 0.1 mg/kg)
n=10 Participants
Participants received 0.1 mg/kg of GEN1029 every 2 weeks (Q2W) until the end of treatment.
|
Biweekly Regimen (GEN1029 0.2 mg/kg)
n=7 Participants
Participants received 0.2 mg/kg of GEN1029 Q2W until the end of treatment.
|
Biweekly Regimen (GEN1029 0.3 mg/kg)
n=4 Participants
Participants received 0.3 mg/kg of GEN1029 Q2W until the end of treatment.
|
Biweekly Regimen (GEN1029 1.0 mg/kg)
n=11 Participants
Participants received 1.0 mg/kg of GEN1029 Q2W until the end of treatment.
|
Biweekly Regimen (GEN1029 2.0 mg/kg)
n=7 Participants
Participants received 2.0 mg/kg of GEN1029 Q2W until the end of treatment.
|
Biweekly Regimen (GEN1029 3.0 mg/kg)
n=7 Participants
Participants received 3.0 mg/kg of GEN1029 Q2W until the end of treatment.
|
|---|---|---|---|---|---|---|
|
Progression-Free Survival (PFS) According to RECIST 1.1
|
2.5 months
Interval 0.5 to 3.9
|
1.4 months
Interval 0.5 to
Upper limit of 95% confidence interval was not reached due to insufficient events being observed at the time of the analysis.
|
2.4 months
Interval 0.8 to
Upper limit of 95% confidence interval was not reached due to insufficient events being observed at the time of the analysis.
|
1.9 months
Interval 1.2 to
Upper limit of 95% confidence interval was not reached due to insufficient events being observed at the time of the analysis.
|
1.2 months
Interval 1.1 to
Upper limit of 95% confidence interval was not reached due to insufficient events being observed at the time of the analysis.
|
1.2 months
Interval 1.0 to
Upper limit of 95% confidence interval was not reached due to insufficient events being observed at the time of the analysis.
|
SECONDARY outcome
Timeframe: From Day 1 through 8.8 months (corresponding to maximum observed duration)Population: Full analysis set included all participants who received at least one dose of GEN1029 and were analyzed according to the actual trial treatment received.
Overall survival was defined as the number of days from date of first study drug administration to death due to any cause. If a subject was not known to have died, then OS was censored, and the censoring date was the latest date the subject was known to be alive (on or before the cut-off date). The OS was estimated using Kaplan-Meier method.
Outcome measures
| Measure |
Biweekly Regimen (GEN1029 0.1 mg/kg)
n=10 Participants
Participants received 0.1 mg/kg of GEN1029 every 2 weeks (Q2W) until the end of treatment.
|
Biweekly Regimen (GEN1029 0.2 mg/kg)
n=7 Participants
Participants received 0.2 mg/kg of GEN1029 Q2W until the end of treatment.
|
Biweekly Regimen (GEN1029 0.3 mg/kg)
n=4 Participants
Participants received 0.3 mg/kg of GEN1029 Q2W until the end of treatment.
|
Biweekly Regimen (GEN1029 1.0 mg/kg)
n=11 Participants
Participants received 1.0 mg/kg of GEN1029 Q2W until the end of treatment.
|
Biweekly Regimen (GEN1029 2.0 mg/kg)
n=7 Participants
Participants received 2.0 mg/kg of GEN1029 Q2W until the end of treatment.
|
Biweekly Regimen (GEN1029 3.0 mg/kg)
n=7 Participants
Participants received 3.0 mg/kg of GEN1029 Q2W until the end of treatment.
|
|---|---|---|---|---|---|---|
|
Overall Survival (OS) According to RECIST 1.1
|
7.0 months
Interval 2.3 to
Upper limit of 95% confidence interval was not reached due to insufficient events being observed at the time of the analysis.
|
6.4 months
Interval 1.8 to
Upper limit of 95% confidence interval was not reached due to insufficient events being observed at the time of the analysis.
|
4.9 months
95% confidence interval was not reached due to insufficient events being observed at the time of the analysis.
|
7.1 months
Interval 1.7 to
Upper limit of 95% confidence interval was not reached due to insufficient events being observed at the time of the analysis.
|
4.7 months
Interval 2.8 to
Upper limit of 95% confidence interval was not reached due to insufficient events being observed at the time of the analysis.
|
6.9 months
95% confidence interval was not reached due to insufficient events being observed at the time of the analysis.
|
SECONDARY outcome
Timeframe: From Day 1 through 8.8 months (corresponding to maximum observed duration)Population: Full analysis set included all participants who received at least one dose of GEN1029 and were analyzed according to the actual trial treatment received. Participants who achieved confirmed OR by the investigator assessment were evaluated for this outcome measure.
The radiological evaluation based on RECIST v1.1 was assessed using CT scan/PET-CT scan. The DoR was defined as duration from the first documentation of confirmed OR (CR or PR) to date of first progressive disease (PD) or death.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Day 1 through 8.8 months (corresponding to maximum observed duration)Population: Full analysis set included all participants who received at least one dose of GEN1029 and were analyzed according to the actual trial treatment received. Participants who achieved confirmed OR by the investigator assessment were evaluated for this outcome measure.
TTR is defined as the number of days from first dose of study drug to the first documented confirmed CR or PR, which must be subsequently confirmed.
Outcome measures
Outcome data not reported
Adverse Events
Biweekly Regimen (GEN1029 0.1 mg/kg)
Serious events: 3 serious events
Other events: 8 other events
Deaths: 3 deaths
Biweekly Regimen (GEN1029 0.2 mg/kg)
Serious events: 3 serious events
Other events: 7 other events
Deaths: 3 deaths
Biweekly Regimen (GEN1029 0.3 mg/kg)
Serious events: 2 serious events
Other events: 4 other events
Deaths: 1 deaths
Biweekly Regimen (GEN1029 1.0 mg/kg)
Serious events: 9 serious events
Other events: 11 other events
Deaths: 5 deaths
Biweekly Regimen (GEN1029 2.0 mg/kg)
Serious events: 6 serious events
Other events: 7 other events
Deaths: 4 deaths
Biweekly Regimen (GEN1029 3.0 mg/kg)
Serious events: 4 serious events
Other events: 7 other events
Deaths: 1 deaths
Priming Regimen (GEN1029 0.1 mg/kg)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Intensified Regimen (GEN1029 1.0 mg/kg)
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Biweekly Regimen (GEN1029 0.1 mg/kg)
n=10 participants at risk
Participants received 0.1 mg/kg of GEN1029 every 2 weeks (Q2W) until the end of treatment.
|
Biweekly Regimen (GEN1029 0.2 mg/kg)
n=7 participants at risk
Participants received 0.2 mg/kg of GEN1029 Q2W until the end of treatment.
|
Biweekly Regimen (GEN1029 0.3 mg/kg)
n=4 participants at risk
Participants received 0.3 mg/kg of GEN1029 Q2W until the end of treatment.
|
Biweekly Regimen (GEN1029 1.0 mg/kg)
n=11 participants at risk
Participants received 1.0 mg/kg of GEN1029 Q2W until the end of treatment.
|
Biweekly Regimen (GEN1029 2.0 mg/kg)
n=7 participants at risk
Participants received 2.0 mg/kg of GEN1029 Q2W until the end of treatment.
|
Biweekly Regimen (GEN1029 3.0 mg/kg)
n=7 participants at risk
Participants received 3.0 mg/kg of GEN1029 Q2W until the end of treatment.
|
Priming Regimen (GEN1029 0.1 mg/kg)
n=1 participants at risk
Participants received a priming dose of 0.1 mg/kg of GEN1029 on Cycle 1 Day 1. After 14 days and thereafter once every 14 days, participants received full dose of 0.3 mg/kg until the end of treatment.
|
Intensified Regimen (GEN1029 1.0 mg/kg)
n=1 participants at risk
Participants received 1.0 mg/kg of GEN1029 once a week (Q1W) for the first 8 weeks then Q2W until the end of treatment.
|
|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Sinus Tachycardia
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
25.0%
1/4 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/11 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
9.1%
1/11 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
9.1%
1/11 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
42.9%
3/7 • Number of events 4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/11 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Gastrointestinal disorders
Gastrointestinal Inflammation
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/11 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Gastrointestinal disorders
Large Intestinal Obstruction
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
9.1%
1/11 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/11 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
9.1%
1/11 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/11 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
General disorders
Fatigue
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/11 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
General disorders
Hernia
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
9.1%
1/11 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
General disorders
Pyrexia
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
25.0%
1/4 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
18.2%
2/11 • Number of events 2 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Hepatobiliary disorders
Drug-Induced Liver Injury
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
9.1%
1/11 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
100.0%
1/1 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
9.1%
1/11 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
25.0%
1/4 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/11 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Hepatobiliary disorders
Jaundice Cholestatic
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
9.1%
1/11 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Infections and infestations
Anal Abscess
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
9.1%
1/11 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Infections and infestations
Bronchitis
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/11 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Infections and infestations
Cystitis
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/11 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Infections and infestations
Escherichia Urinary Tract Infection
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/11 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
10.0%
1/10 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/11 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Infections and infestations
Peritonitis
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/11 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Infections and infestations
Tinea Versicolour
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
25.0%
1/4 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/11 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
9.1%
1/11 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
10.0%
1/10 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/11 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Investigations
Alanine Aminotransferase Increased
|
10.0%
1/10 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
25.0%
1/4 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
9.1%
1/11 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
42.9%
3/7 • Number of events 3 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Investigations
Aspartate Aminotransferase Increased
|
10.0%
1/10 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
25.0%
1/4 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
9.1%
1/11 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
28.6%
2/7 • Number of events 2 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Investigations
International Normalised Ratio Increased
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/11 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Investigations
Prothrombin Time Prolonged
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/11 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/11 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Neoplasm Progression
|
10.0%
1/10 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
28.6%
2/7 • Number of events 2 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
27.3%
3/11 • Number of events 3 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Skin and subcutaneous tissue disorders
Lichenoid Keratosis
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/11 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
Other adverse events
| Measure |
Biweekly Regimen (GEN1029 0.1 mg/kg)
n=10 participants at risk
Participants received 0.1 mg/kg of GEN1029 every 2 weeks (Q2W) until the end of treatment.
|
Biweekly Regimen (GEN1029 0.2 mg/kg)
n=7 participants at risk
Participants received 0.2 mg/kg of GEN1029 Q2W until the end of treatment.
|
Biweekly Regimen (GEN1029 0.3 mg/kg)
n=4 participants at risk
Participants received 0.3 mg/kg of GEN1029 Q2W until the end of treatment.
|
Biweekly Regimen (GEN1029 1.0 mg/kg)
n=11 participants at risk
Participants received 1.0 mg/kg of GEN1029 Q2W until the end of treatment.
|
Biweekly Regimen (GEN1029 2.0 mg/kg)
n=7 participants at risk
Participants received 2.0 mg/kg of GEN1029 Q2W until the end of treatment.
|
Biweekly Regimen (GEN1029 3.0 mg/kg)
n=7 participants at risk
Participants received 3.0 mg/kg of GEN1029 Q2W until the end of treatment.
|
Priming Regimen (GEN1029 0.1 mg/kg)
n=1 participants at risk
Participants received a priming dose of 0.1 mg/kg of GEN1029 on Cycle 1 Day 1. After 14 days and thereafter once every 14 days, participants received full dose of 0.3 mg/kg until the end of treatment.
|
Intensified Regimen (GEN1029 1.0 mg/kg)
n=1 participants at risk
Participants received 1.0 mg/kg of GEN1029 once a week (Q1W) for the first 8 weeks then Q2W until the end of treatment.
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
1/10 • Number of events 2 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
18.2%
2/11 • Number of events 2 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
28.6%
2/7 • Number of events 2 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
9.1%
1/11 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Gastrointestinal disorders
Ascites
|
10.0%
1/10 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/11 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Gastrointestinal disorders
Constipation
|
40.0%
4/10 • Number of events 4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
9.1%
1/11 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Gastrointestinal disorders
Diarrhoea
|
10.0%
1/10 • Number of events 3 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
27.3%
3/11 • Number of events 3 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
57.1%
4/7 • Number of events 6 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
28.6%
2/7 • Number of events 2 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
100.0%
1/1 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Gastrointestinal disorders
Dyspepsia
|
10.0%
1/10 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
9.1%
1/11 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
9.1%
1/11 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Gastrointestinal disorders
Enteritis
|
10.0%
1/10 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/11 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/11 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Gastrointestinal disorders
Gastrointestinal oedema
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/11 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
10.0%
1/10 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
25.0%
1/4 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/11 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
9.1%
1/11 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
9.1%
1/11 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Gastrointestinal disorders
Nausea
|
20.0%
2/10 • Number of events 2 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
9.1%
1/11 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
42.9%
3/7 • Number of events 3 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
100.0%
1/1 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
9.1%
1/11 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Gastrointestinal disorders
Rectal tenesmus
|
10.0%
1/10 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/11 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Gastrointestinal disorders
Toothache
|
10.0%
1/10 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
9.1%
1/11 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
1/10 • Number of events 2 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
25.0%
1/4 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
9.1%
1/11 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
57.1%
4/7 • Number of events 6 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
28.6%
2/7 • Number of events 2 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
General disorders
Asthenia
|
10.0%
1/10 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
18.2%
2/11 • Number of events 4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
28.6%
2/7 • Number of events 5 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
28.6%
2/7 • Number of events 3 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
General disorders
Chest discomfort
|
20.0%
2/10 • Number of events 2 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
25.0%
1/4 • Number of events 2 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
9.1%
1/11 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
General disorders
Chest pain
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/11 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 2 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
General disorders
Chills
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
9.1%
1/11 • Number of events 2 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
General disorders
Drug withdrawal syndrome
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/11 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
General disorders
Early satiety
|
10.0%
1/10 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/11 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
General disorders
Face oedema
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/11 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
General disorders
Fatigue
|
40.0%
4/10 • Number of events 4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
25.0%
1/4 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
45.5%
5/11 • Number of events 8 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
28.6%
2/7 • Number of events 2 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
100.0%
1/1 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
General disorders
Mucosal inflammation
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
27.3%
3/11 • Number of events 3 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
General disorders
Oedema
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
18.2%
2/11 • Number of events 2 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
General disorders
Oedema peripheral
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/11 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
28.6%
2/7 • Number of events 2 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
General disorders
Pain
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/11 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
100.0%
1/1 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
General disorders
Pyrexia
|
10.0%
1/10 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
36.4%
4/11 • Number of events 5 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Hepatobiliary disorders
Biliary dilatation
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
9.1%
1/11 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/11 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
25.0%
1/4 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
9.1%
1/11 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 2 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
100.0%
1/1 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/11 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Infections and infestations
Bronchitis
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/11 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Infections and infestations
Cystitis
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
9.1%
1/11 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Infections and infestations
Lower respiratory tract infection
|
10.0%
1/10 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/11 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Infections and infestations
Oral candidiasis
|
10.0%
1/10 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
9.1%
1/11 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Infections and infestations
Oral herpes
|
10.0%
1/10 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/11 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Infections and infestations
Pneumonia
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/11 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Infections and infestations
Rash pustular
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
25.0%
1/4 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/11 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Infections and infestations
Rhinitis
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
9.1%
1/11 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Infections and infestations
Trichomoniasis
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
9.1%
1/11 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
9.1%
1/11 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Infections and infestations
Urinary tract infection
|
10.0%
1/10 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/11 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
28.6%
2/7 • Number of events 2 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
9.1%
1/11 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
28.6%
2/7 • Number of events 3 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
25.0%
1/4 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/11 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
9.1%
1/11 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Investigations
Alanine aminotransferase increased
|
30.0%
3/10 • Number of events 5 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
42.9%
3/7 • Number of events 5 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
50.0%
2/4 • Number of events 5 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
54.5%
6/11 • Number of events 14 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
42.9%
3/7 • Number of events 3 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
28.6%
2/7 • Number of events 2 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
100.0%
1/1 • Number of events 2 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
100.0%
1/1 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Investigations
Amylase increased
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
25.0%
1/4 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/11 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Investigations
Aspartate aminotransferase increased
|
40.0%
4/10 • Number of events 5 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
57.1%
4/7 • Number of events 6 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
50.0%
2/4 • Number of events 5 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
63.6%
7/11 • Number of events 14 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
57.1%
4/7 • Number of events 4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
42.9%
3/7 • Number of events 3 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
100.0%
1/1 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Investigations
Blood alkaline phosphatase increased
|
10.0%
1/10 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
27.3%
3/11 • Number of events 4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
42.9%
3/7 • Number of events 3 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
9.1%
1/11 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Investigations
Blood creatinine increased
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 2 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/11 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Investigations
C-reactive protein increased
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
9.1%
1/11 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Investigations
Electrocardiogram T wave inversion
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/11 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
18.2%
2/11 • Number of events 2 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
28.6%
2/7 • Number of events 2 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Investigations
Lipase increased
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
25.0%
1/4 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
9.1%
1/11 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Investigations
Transaminases increased
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
9.1%
1/11 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Investigations
Weight decreased
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
9.1%
1/11 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Investigations
Weight increased
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
9.1%
1/11 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
20.0%
2/10 • Number of events 2 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
25.0%
1/4 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
36.4%
4/11 • Number of events 4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
42.9%
3/7 • Number of events 3 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
28.6%
2/7 • Number of events 2 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Metabolism and nutrition disorders
Dehydration
|
10.0%
1/10 • Number of events 3 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
25.0%
1/4 • Number of events 2 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
9.1%
1/11 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
100.0%
1/1 • Number of events 3 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/11 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
25.0%
1/4 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/11 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
18.2%
2/11 • Number of events 2 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
10.0%
1/10 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
25.0%
1/4 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/11 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
25.0%
1/4 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
18.2%
2/11 • Number of events 3 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
42.9%
3/7 • Number of events 4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Vascular disorders
Hypotension
|
10.0%
1/10 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/11 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
9.1%
1/11 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
9.1%
1/11 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
57.1%
4/7 • Number of events 5 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
9.1%
1/11 • Number of events 2 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
28.6%
2/7 • Number of events 2 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
10.0%
1/10 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
25.0%
1/4 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/11 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 2 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/11 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
28.6%
2/7 • Number of events 2 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
1/10 • Number of events 2 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
27.3%
3/11 • Number of events 6 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
100.0%
1/1 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.0%
2/10 • Number of events 2 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
25.0%
1/4 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/11 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Musculoskeletal and connective tissue disorders
Hypertrophic osteoarthropathy
|
10.0%
1/10 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/11 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
9.1%
1/11 • Number of events 2 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
10.0%
1/10 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/11 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/11 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
100.0%
1/1 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/11 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/11 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
28.6%
2/7 • Number of events 2 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
9.1%
1/11 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
25.0%
1/4 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/11 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 2 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 3 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
25.0%
1/4 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/11 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
100.0%
1/1 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
9.1%
1/11 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Nervous system disorders
Headache
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/11 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/11 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/11 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Nervous system disorders
Somnolence
|
10.0%
1/10 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/11 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/11 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Psychiatric disorders
Insomnia
|
30.0%
3/10 • Number of events 3 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
18.2%
2/11 • Number of events 2 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/11 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Renal and urinary disorders
Acute kidney injury
|
10.0%
1/10 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/11 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Renal and urinary disorders
Bladder spasm
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
9.1%
1/11 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
9.1%
1/11 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/11 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
25.0%
1/4 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/11 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
9.1%
1/11 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
25.0%
1/4 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/11 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
18.2%
2/11 • Number of events 2 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 3 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
9.1%
1/11 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.0%
1/10 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 2 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
9.1%
1/11 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
42.9%
3/7 • Number of events 3 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
10.0%
1/10 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/11 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
10.0%
1/10 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/11 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/11 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/11 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
9.1%
1/11 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
18.2%
2/11 • Number of events 2 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/11 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/11 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
18.2%
2/11 • Number of events 2 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
28.6%
2/7 • Number of events 2 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
18.2%
2/11 • Number of events 2 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
28.6%
2/7 • Number of events 2 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Skin and subcutaneous tissue disorders
Solar dermatitis
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/11 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/11 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Vascular disorders
Hot flush
|
10.0%
1/10 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
9.1%
1/11 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Vascular disorders
Spider vein
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/11 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Blood and lymphatic system disorders
Anaemia
|
20.0%
2/10 • Number of events 2 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
28.6%
2/7 • Number of events 2 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
25.0%
1/4 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
27.3%
3/11 • Number of events 3 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
28.6%
2/7 • Number of events 2 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 3 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
100.0%
1/1 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
9.1%
1/11 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Blood and lymphatic system disorders
Lymphopenia
|
10.0%
1/10 • Number of events 3 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/11 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
10.0%
1/10 • Number of events 2 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/11 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Cardiac disorders
Tachycardia
|
10.0%
1/10 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/11 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/11 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
100.0%
1/1 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/11 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Eye disorders
Diplopia
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/11 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Eye disorders
Extraocular muscle paresis
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/11 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Eye disorders
Eye pain
|
10.0%
1/10 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/11 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Eye disorders
Visual impairment
|
10.0%
1/10 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/11 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/10 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/4 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
9.1%
1/11 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
|
Gastrointestinal disorders
Abdominal distension
|
10.0%
1/10 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
14.3%
1/7 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
25.0%
1/4 • Number of events 1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/11 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
28.6%
2/7 • Number of events 2 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/7 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
0.00%
0/1 • For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is at least 12 months but less than 18 months from the end of study (database lock).The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER