Trial Outcomes & Findings for Phase Ib/II of TG4001 and Avelumab in HPV16 Positive R/M Cancers (NCT NCT03260023)
NCT ID: NCT03260023
Last Updated: 2026-02-05
Results Overview
Dose limiting toxicities (DLTs) includes the following: * Grade ≥ 3 drug related adverse event (AEs). However, fatigue, nausea/vomiting adequately treated with anti-emetics, endocrinopathies adequately controlled with one physiologic hormone replacement, skin toxicity and single laboratory values out of normal range without any clinical correlate, asymptomatic grade ≥3 lipase or amylase elevation, tumor flare defined as local pain, irritation, or rash localized at sites of known or suspected tumor or a transient Grade 3 infusion adverse event are excluded. * Liver function test abnormality: * AST or ALT \> 5 x ULN * Total bilirubin \> 3 x ULN * Concurrent AST or ALT \> 3 x ULN and total bilirubin \> 2 x ULN * Drug related AE requiring treatment interruption for more than 2 weeks
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE1/PHASE2
Target enrollment
143 participants
Primary outcome timeframe
From Day 1 to Day 28
Results posted on
2026-02-05
Participant Flow
From 01 September 2017 through 27 March 2024, a total of 361 participants were screened. Phase Ib: 01 September 2017 until 11 April 2018 Phase II part 1: 04 October 2018 until 10 August 2020 Phase II part 2: 03 Jun 2021 until 27 March 2024
Out of 361 screened participants, 143 were included in the trial and 142 were administered with trial interventions. 218 participants were not included (main reasons: 48.6% inclusion criterion of having histologically or cytologically documented HPV-16+ cancer, 18.8% inclusion criterion of having adequate hematological, hepatic and renal function)
Participant milestones
| Measure |
Phase I - TG4001 5x10e6 Pfu + Avelumab
Participants received 5x10e6 pfu TG4001 subcutaneously along with 10 mg/kg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
Phase I - TG4001 5x10e7 Pfu + Avelumab
Participants received 5x10e7 pfu TG4001 subcutaneously along with 10 mg/kg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
Phase II Part 1 - TG4001 5x10e7 Pfu + Avelumab
Participants received 5x10e7 pfu TG4001 subcutaneously along with 10 mg/kg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
Phase II Part 2 - Cohort A - Participants Without Liver Metastases - TG4001 5x10e7 Pfu + Avelumab
Participants received 5x10e7 pfu TG4001 subcutaneously along with 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
Phase II Part 2 - Cohort A - Participants Without Liver Metastases - Avelumab
Participants received 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
Phase II Part 2 - Cohort B - Participants With Liver Metastases - TG4001 5x10e7 Pfu + Avelumab
Participants received 5x10e7 pfu TG4001 subcutaneously along with 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
Phase II Part 2 - Cohort B - Participants With Liver Metastases - Avelumab
Participants received 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
6
|
34
|
46
|
44
|
5
|
5
|
|
Overall Study
COMPLETED
|
3
|
5
|
25
|
35
|
33
|
4
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
9
|
11
|
11
|
1
|
2
|
Reasons for withdrawal
| Measure |
Phase I - TG4001 5x10e6 Pfu + Avelumab
Participants received 5x10e6 pfu TG4001 subcutaneously along with 10 mg/kg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
Phase I - TG4001 5x10e7 Pfu + Avelumab
Participants received 5x10e7 pfu TG4001 subcutaneously along with 10 mg/kg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
Phase II Part 1 - TG4001 5x10e7 Pfu + Avelumab
Participants received 5x10e7 pfu TG4001 subcutaneously along with 10 mg/kg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
Phase II Part 2 - Cohort A - Participants Without Liver Metastases - TG4001 5x10e7 Pfu + Avelumab
Participants received 5x10e7 pfu TG4001 subcutaneously along with 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
Phase II Part 2 - Cohort A - Participants Without Liver Metastases - Avelumab
Participants received 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
Phase II Part 2 - Cohort B - Participants With Liver Metastases - TG4001 5x10e7 Pfu + Avelumab
Participants received 5x10e7 pfu TG4001 subcutaneously along with 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
Phase II Part 2 - Cohort B - Participants With Liver Metastases - Avelumab
Participants received 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
4
|
4
|
4
|
1
|
2
|
|
Overall Study
Clinical Progression
|
0
|
1
|
3
|
1
|
0
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
3
|
0
|
0
|
|
Overall Study
Under trial intervention
|
0
|
0
|
2
|
5
|
3
|
0
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Phase I - TG4001 5x10e6 Pfu + Avelumab
n=3 Participants
Participants received 5x10e6 pfu TG4001 subcutaneously along with 10 mg/kg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
Phase I - TG4001 5x10e7 Pfu + Avelumab
n=6 Participants
Participants received 5x10e7 pfu TG4001 subcutaneously along with 10 mg/kg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
Phase II Part 1 - TG4001 5x10e7 Pfu + Avelumab
n=34 Participants
Participants received 5x10e7 pfu TG4001 subcutaneously along with 10 mg/kg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
Phase II Part 2 - Cohort A - Participants Without Liver Metastases - TG4001 5x10e7 Pfu + Avelumab
n=46 Participants
Participants received 5x10e7 pfu TG4001 subcutaneously along with 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
Phase II Part 2 - Cohort A - Participants Without Liver Metastases - Avelumab
n=44 Participants
Participants received 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
Phase II Part 2 - Cohort B - Participants With Liver Metastases - TG4001 5x10e7 Pfu + Avelumab
n=5 Participants
Participants received 5x10e7 pfu TG4001 subcutaneously along with 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
Phase II Part 2 - Cohort B - Participants With Liver Metastases - Avelumab
n=4 Participants
Participants received 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
Total
n=142 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=46 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=142 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
25 Participants
n=34 Participants
|
37 Participants
n=46 Participants
|
30 Participants
n=44 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
104 Participants
n=142 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
9 Participants
n=34 Participants
|
9 Participants
n=46 Participants
|
14 Participants
n=44 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
38 Participants
n=142 Participants
|
|
Age, Continuous
|
52.0 years
n=3 Participants
|
65.5 years
n=6 Participants
|
56.0 years
n=34 Participants
|
57.0 years
n=46 Participants
|
56.5 years
n=44 Participants
|
43.0 years
n=5 Participants
|
67.5 years
n=4 Participants
|
56.0 years
n=142 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
25 Participants
n=34 Participants
|
43 Participants
n=46 Participants
|
44 Participants
n=44 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
125 Participants
n=142 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=3 Participants
|
4 Participants
n=6 Participants
|
9 Participants
n=34 Participants
|
3 Participants
n=46 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
17 Participants
n=142 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
0 participants
n=3 Participants
|
0 participants
n=6 Participants
|
0 participants
n=34 Participants
|
1 participants
n=46 Participants
|
0 participants
n=44 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=142 Participants
|
|
Region of Enrollment
France
|
3 participants
n=3 Participants
|
6 participants
n=6 Participants
|
34 participants
n=34 Participants
|
39 participants
n=46 Participants
|
37 participants
n=44 Participants
|
4 participants
n=5 Participants
|
4 participants
n=4 Participants
|
127 participants
n=142 Participants
|
|
Region of Enrollment
Spain
|
0 participants
n=3 Participants
|
0 participants
n=6 Participants
|
0 participants
n=34 Participants
|
6 participants
n=46 Participants
|
7 participants
n=44 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
14 participants
n=142 Participants
|
|
Primary tumor location
Cervical
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
8 Participants
n=34 Participants
|
25 Participants
n=46 Participants
|
24 Participants
n=44 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
61 Participants
n=142 Participants
|
|
Primary tumor location
Anal
|
2 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
17 Participants
n=34 Participants
|
14 Participants
n=46 Participants
|
13 Participants
n=44 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
52 Participants
n=142 Participants
|
|
Primary tumor location
Oropharyngeal
|
1 Participants
n=3 Participants
|
4 Participants
n=6 Participants
|
5 Participants
n=34 Participants
|
0 Participants
n=46 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
10 Participants
n=142 Participants
|
|
Primary tumor location
Vaginal
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
3 Participants
n=34 Participants
|
2 Participants
n=46 Participants
|
3 Participants
n=44 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
9 Participants
n=142 Participants
|
|
Primary tumor location
Vulvar
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=34 Participants
|
4 Participants
n=46 Participants
|
4 Participants
n=44 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
9 Participants
n=142 Participants
|
|
Primary tumor location
Penile
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=34 Participants
|
1 Participants
n=46 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=142 Participants
|
|
ECOG Performance Status
ECOG Status 0
|
0 Participants
n=3 Participants
|
4 Participants
n=6 Participants
|
10 Participants
n=34 Participants
|
18 Participants
n=46 Participants
|
11 Participants
n=44 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
47 Participants
n=142 Participants
|
|
ECOG Performance Status
ECOG Status 1
|
3 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
24 Participants
n=34 Participants
|
28 Participants
n=46 Participants
|
33 Participants
n=44 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
95 Participants
n=142 Participants
|
PRIMARY outcome
Timeframe: From Day 1 to Day 28Population: Phase Ib : All participants included and who received any amount of study treatment were included in the SAF. Any participant who was assigned a participant number, but did not receive any study treatment was not included in the SAF. Phase II part 1 and Phase II part 2: the outcome measure safety and tolerability has not been defined as primary endpoint. Therefore Phase II part 1 and Phase II part 2 are not included in the analysis population for safety and tolerability as primary endpoint.
Dose limiting toxicities (DLTs) includes the following: * Grade ≥ 3 drug related adverse event (AEs). However, fatigue, nausea/vomiting adequately treated with anti-emetics, endocrinopathies adequately controlled with one physiologic hormone replacement, skin toxicity and single laboratory values out of normal range without any clinical correlate, asymptomatic grade ≥3 lipase or amylase elevation, tumor flare defined as local pain, irritation, or rash localized at sites of known or suspected tumor or a transient Grade 3 infusion adverse event are excluded. * Liver function test abnormality: * AST or ALT \> 5 x ULN * Total bilirubin \> 3 x ULN * Concurrent AST or ALT \> 3 x ULN and total bilirubin \> 2 x ULN * Drug related AE requiring treatment interruption for more than 2 weeks
Outcome measures
| Measure |
Phase II Part 2 - Cohort A - Anal Cancer - TG4001 5x10e7 Pfu + Avelumab
Participants without liver metastases received 5x10e7 pfu TG4001 subcutaneously along with 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
Phase II Part 2 - Cohort A - Anal Cancer - Avelumab
Participants without liver metastases received 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
Phase II Part 2 - Cohort A - Genital Cancer - TG4001 5x10e7 Pfu + Avelumab
Participants without liver metastases received 5x10e7 pfu TG4001 subcutaneously along with 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
Phase II Part 2 - Cohort A - Genital Cancer - Avelumab
Participants without liver metastases received 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
Phase I - TG4001 5x10e6 Pfu + Avelumab
n=3 Participants
Participants received 5x10e6 pfu TG4001 subcutaneously along with 10 mg/kg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
Phase I - TG4001 5x10e7 Pfu + Avelumab
n=6 Participants
Participants received 5x10e7 pfu TG4001 subcutaneously along with 10 mg/kg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
|---|---|---|---|---|---|---|
|
Phase Ib: To Evaluate the Safety and Tolerability of the Combination of TG4001 Plus Avelumab in Participants With Recurrent or Metastatic HPV-16 Positive Advanced Malignancies
|
—
|
—
|
—
|
—
|
0 DLT
|
0 DLT
|
PRIMARY outcome
Timeframe: From treatment start, every 6 weeks for the first 9 months, then every 12 weeks up to 2 years.Population: Phase II part 1 (Evaluable per protocol): Participants dosed with both IMPs and with at least baseline and post-baseline evaluable CT-scan at week 6 according to RECIST 1.1 and no major inc/exc, dosing or protocol violation, except if participant progressed or died due to disease. Phase Ib and phase II part 2: the outcome measure ORR has not been defined as primary endpoint. Therefore Phase Ib and phase II part 2 are not included in the analysis population for ORR as primary endpoint.
Percentage of participants whose best overall response is either a Complete Response or a Partial Response according to Response Evaluation Criteria In Solid Tumors (RECIST v1.0) criteria over the the total number of evaluable participants. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT/MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.", or similar definition that is accurate and appropriate.
Outcome measures
| Measure |
Phase II Part 2 - Cohort A - Anal Cancer - TG4001 5x10e7 Pfu + Avelumab
Participants without liver metastases received 5x10e7 pfu TG4001 subcutaneously along with 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
Phase II Part 2 - Cohort A - Anal Cancer - Avelumab
Participants without liver metastases received 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
Phase II Part 2 - Cohort A - Genital Cancer - TG4001 5x10e7 Pfu + Avelumab
Participants without liver metastases received 5x10e7 pfu TG4001 subcutaneously along with 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
Phase II Part 2 - Cohort A - Genital Cancer - Avelumab
Participants without liver metastases received 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
Phase I - TG4001 5x10e6 Pfu + Avelumab
n=30 Participants
Participants received 5x10e6 pfu TG4001 subcutaneously along with 10 mg/kg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
Phase I - TG4001 5x10e7 Pfu + Avelumab
Participants received 5x10e7 pfu TG4001 subcutaneously along with 10 mg/kg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
|---|---|---|---|---|---|---|
|
Phase II Part 1: Overall Response Rate (ORR) by RECIST 1.1
Overall Response Rate
|
—
|
—
|
—
|
—
|
16.67 percentage of participants
Interval 5.64 to 34.72
|
—
|
|
Phase II Part 1: Overall Response Rate (ORR) by RECIST 1.1
Disease Control Rate (DCR)
|
—
|
—
|
—
|
—
|
46.67 percentage of participants
Interval 28.34 to 65.67
|
—
|
|
Phase II Part 1: Overall Response Rate (ORR) by RECIST 1.1
Complete Response (CR)
|
—
|
—
|
—
|
—
|
3.33 percentage of participants
Interval 0.08 to 17.22
|
—
|
|
Phase II Part 1: Overall Response Rate (ORR) by RECIST 1.1
Partial Response (PR)
|
—
|
—
|
—
|
—
|
13.33 percentage of participants
Interval 3.76 to 30.72
|
—
|
|
Phase II Part 1: Overall Response Rate (ORR) by RECIST 1.1
Stable Disease (SD)
|
—
|
—
|
—
|
—
|
30.0 percentage of participants
Interval 14.73 to 49.4
|
—
|
|
Phase II Part 1: Overall Response Rate (ORR) by RECIST 1.1
Progressive disease (PD)
|
—
|
—
|
—
|
—
|
53.33 percentage of participants
Interval 34.33 to 71.66
|
—
|
PRIMARY outcome
Timeframe: From randomization: Every 6 weeks for the first 9 months, then every 12 weeks through study completion, for an average of 1 year.Population: Phase II part 2, Cohort A: All randomized participants who were adminstered at least one dose of IMP(s) according to the treatment allocated at randomization. (FAS) For Phase Ib, Phase II part 1 and Phase II part 2 Cohort B : the outcome measure PFS has not been defined as primary endpoint Therefore Phase Ib, Phase II part 1 and Phase II part 2 Cohort B are not included in the analysis population for PFS as primary endpoint.
PFS is defined as the time from the date of randomization to the date of first documented tumor progression or death due to any cause, whichever occurs first. If a participant has not had a PFS event at the cut-off date for analysis or at the date when a further antineoplastic therapy (other than those planned as study treatment in the protocol) is started, PFS will be censored at the date of last evaluable tumor assessment before the cut-off or start of further antineoplastic therapy.
Outcome measures
| Measure |
Phase II Part 2 - Cohort A - Anal Cancer - TG4001 5x10e7 Pfu + Avelumab
Participants without liver metastases received 5x10e7 pfu TG4001 subcutaneously along with 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
Phase II Part 2 - Cohort A - Anal Cancer - Avelumab
Participants without liver metastases received 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
Phase II Part 2 - Cohort A - Genital Cancer - TG4001 5x10e7 Pfu + Avelumab
Participants without liver metastases received 5x10e7 pfu TG4001 subcutaneously along with 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
Phase II Part 2 - Cohort A - Genital Cancer - Avelumab
Participants without liver metastases received 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
Phase I - TG4001 5x10e6 Pfu + Avelumab
n=46 Participants
Participants received 5x10e6 pfu TG4001 subcutaneously along with 10 mg/kg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
Phase I - TG4001 5x10e7 Pfu + Avelumab
n=44 Participants
Participants received 5x10e7 pfu TG4001 subcutaneously along with 10 mg/kg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
|---|---|---|---|---|---|---|
|
Phase II Part 2 Cohort A: Progression Free Survival (PFS) by RECIST 1.1
|
—
|
—
|
—
|
—
|
3.0 Months
Interval 2.0 to 4.4
|
2.8 Months
Interval 1.7 to 4.2
|
PRIMARY outcome
Timeframe: From randomization: Every 6 weeks for the first 9 months, then every 12 weeks through study completion, for an average of 1 year.Population: Phase II part 2 Cohort A: All randomized participants who were adminstered at least one dose of IMP(s) according to the treatment allocated at randomization. (FAS) For Phase Ib, Phase II part 1 and Phase II part 2 Cohort B : the outcome measure PFS has not been defined as primary endpoint. Therefore Phase Ib, Phase II part 1 and Phase II part 2 Cohort B are not included in the analysis population for PFS as primary endpoint.
PFS is defined as the time from the date of randomization to the date of first documented tumor progression or death due to any cause, whichever occurs first. If a participant has not had a PFS event at the cut-off date for analysis or at the date when a further antineoplastic therapy (other than those planned as study treatment in the protocol) is started, PFS will be censored at the date of last evaluable tumor assessment before the cut-off or start of further antineoplastic therapy.
Outcome measures
| Measure |
Phase II Part 2 - Cohort A - Anal Cancer - TG4001 5x10e7 Pfu + Avelumab
n=14 Participants
Participants without liver metastases received 5x10e7 pfu TG4001 subcutaneously along with 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
Phase II Part 2 - Cohort A - Anal Cancer - Avelumab
n=13 Participants
Participants without liver metastases received 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
Phase II Part 2 - Cohort A - Genital Cancer - TG4001 5x10e7 Pfu + Avelumab
n=7 Participants
Participants without liver metastases received 5x10e7 pfu TG4001 subcutaneously along with 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
Phase II Part 2 - Cohort A - Genital Cancer - Avelumab
n=7 Participants
Participants without liver metastases received 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
Phase I - TG4001 5x10e6 Pfu + Avelumab
n=25 Participants
Participants received 5x10e6 pfu TG4001 subcutaneously along with 10 mg/kg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
Phase I - TG4001 5x10e7 Pfu + Avelumab
n=24 Participants
Participants received 5x10e7 pfu TG4001 subcutaneously along with 10 mg/kg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
|---|---|---|---|---|---|---|
|
Progression Free Survival (PFS) Phase II Part 2 Cohort A by Stratification
|
3.0 Months
Interval 1.5 to 5.6
|
3.0 Months
Interval 1.4 to
Upper limit of Confidence Interval has not been achieved due to insufficient number of participants with events.
|
1.6 Months
Interval 1.4 to 5.6
|
7.2 Months
Interval 2.8 to
Upper limit of Confidence Interval has not been achieved due to insufficient number of participants with events.
|
4.3 Months
Interval 1.7 to 12.7
|
2.1 Months
Interval 1.4 to 2.8
|
SECONDARY outcome
Timeframe: From treatment start (phase Ib) / randomization (phase II part 2) : Every 6 weeks for the first 9 months, then every 12 weeks up to 2 years.Population: For Phase Ib / Phase II part 2 Cohort A: All participants who received at least one dose of IMP(s) according to treatment allocation. Phase II part 1 and phase II part 2 Cohort B: the outcome measure ORR has not been defined as secondary endpoint. Therefore Phase II part 1 and phase II part 2 Cohort B are not included in the analysis population for ORR as secondary endpoint.
Percentage of participants whose best overall response is either a Complete Response or a Partial Response according to Response Evaluation Criteria In Solid Tumors (RECIST v1.0) criteria over the the total number of evaluable participants. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT/MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.", or similar definition that is accurate and appropriate.
Outcome measures
| Measure |
Phase II Part 2 - Cohort A - Anal Cancer - TG4001 5x10e7 Pfu + Avelumab
n=46 Participants
Participants without liver metastases received 5x10e7 pfu TG4001 subcutaneously along with 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
Phase II Part 2 - Cohort A - Anal Cancer - Avelumab
n=44 Participants
Participants without liver metastases received 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
Phase II Part 2 - Cohort A - Genital Cancer - TG4001 5x10e7 Pfu + Avelumab
Participants without liver metastases received 5x10e7 pfu TG4001 subcutaneously along with 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
Phase II Part 2 - Cohort A - Genital Cancer - Avelumab
Participants without liver metastases received 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
Phase I - TG4001 5x10e6 Pfu + Avelumab
n=3 Participants
Participants received 5x10e6 pfu TG4001 subcutaneously along with 10 mg/kg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
Phase I - TG4001 5x10e7 Pfu + Avelumab
n=6 Participants
Participants received 5x10e7 pfu TG4001 subcutaneously along with 10 mg/kg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
|---|---|---|---|---|---|---|
|
Overall Response Rate (ORR) by Using RECIST 1.1 : Phase Ib, Phase II Part 2 Cohort A
Overall Response Rate (ORR)
|
15.2 percentage of participants
|
13.6 percentage of participants
|
—
|
—
|
0.0 percentage of participants
|
50.0 percentage of participants
|
|
Overall Response Rate (ORR) by Using RECIST 1.1 : Phase Ib, Phase II Part 2 Cohort A
Disease Control Rate (DCR)
|
65.2 percentage of participants
|
68.2 percentage of participants
|
—
|
—
|
33.3 percentage of participants
|
83.3 percentage of participants
|
|
Overall Response Rate (ORR) by Using RECIST 1.1 : Phase Ib, Phase II Part 2 Cohort A
Complete Response (CR)
|
8.7 percentage of participants
|
2.3 percentage of participants
|
—
|
—
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Overall Response Rate (ORR) by Using RECIST 1.1 : Phase Ib, Phase II Part 2 Cohort A
Partial Response (PR)
|
6.5 percentage of participants
|
11.4 percentage of participants
|
—
|
—
|
0.0 percentage of participants
|
50.0 percentage of participants
|
|
Overall Response Rate (ORR) by Using RECIST 1.1 : Phase Ib, Phase II Part 2 Cohort A
Stable Disease (SD)
|
50.0 percentage of participants
|
54.5 percentage of participants
|
—
|
—
|
33.3 percentage of participants
|
33.3 percentage of participants
|
|
Overall Response Rate (ORR) by Using RECIST 1.1 : Phase Ib, Phase II Part 2 Cohort A
Progressive Disease (PD)
|
34.8 percentage of participants
|
31.8 percentage of participants
|
—
|
—
|
66.7 percentage of participants
|
16.7 percentage of participants
|
SECONDARY outcome
Timeframe: From treatment start (phase Ib, phase II part 1): Every 6 weeks for the first 9 months, then every 12 weeks through study completion, for an average of 1 year.Population: For Phase Ib: All participants included and who received any amount of study treatment. For phase II part 1: Evaluable participants population (EPP) Phase II part 2, cohort A and cohort B : the outcome measure PFS has not been defined as secondary endpoint. Therefore Phase II part 2, cohort A and cohort B are not included in the analysis population for PFS as secondary endpoint.
PFS is defined as the time from the date of first study treatment administration (Phase Ib, Phase II Part1) to the date of first documented tumor progression or death due to any cause, whichever occurs first. If a participant has not had a PFS event at the cut-off date for analysis or at the date when a further antineoplastic therapy (other than those planned as study treatment in the protocol) is started, PFS will be censored at the date of last evaluable tumor assessment before the cut-off or start of further antineoplastic therapy.
Outcome measures
| Measure |
Phase II Part 2 - Cohort A - Anal Cancer - TG4001 5x10e7 Pfu + Avelumab
n=30 Participants
Participants without liver metastases received 5x10e7 pfu TG4001 subcutaneously along with 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
Phase II Part 2 - Cohort A - Anal Cancer - Avelumab
Participants without liver metastases received 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
Phase II Part 2 - Cohort A - Genital Cancer - TG4001 5x10e7 Pfu + Avelumab
Participants without liver metastases received 5x10e7 pfu TG4001 subcutaneously along with 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
Phase II Part 2 - Cohort A - Genital Cancer - Avelumab
Participants without liver metastases received 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
Phase I - TG4001 5x10e6 Pfu + Avelumab
n=3 Participants
Participants received 5x10e6 pfu TG4001 subcutaneously along with 10 mg/kg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
Phase I - TG4001 5x10e7 Pfu + Avelumab
n=6 Participants
Participants received 5x10e7 pfu TG4001 subcutaneously along with 10 mg/kg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
|---|---|---|---|---|---|---|
|
Progression Free Survival (PFS) (Phase Ib, Phase II Part 1)
|
1.5 Months
Interval 1.4 to 5.5
|
—
|
—
|
—
|
1.6 Months
Interval 1.4 to
Upper limit of Confidence Interval has not been achieved due to insufficient number of participants with events.
|
12.0 Months
Interval 1.2 to
Upper limit of Confidence Interval has not been achieved due to insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: From treatment start : Phase Ib, Phase II part 1 / from randomization: Phase II part 2 Cohort A through study completion, for an average of 4.5 years.Population: Phase Ib: All participants included and who received any amount of study treatment. Phase II part 1: Evaluable participants' population. Phase II part 2 Cohort A: All randomized participants who were administered at least one dose of IMP(s) according to the treatment allocated at randomization. For the Phase II part 2 Cohort B, the outcome measure Overall Survival has not been defined as secondary endpoint. Therefore Phase II part 2 Cohort B is not included in the analysis population.
Time from the date of first study treatment administration Phase Ib, Phase II part 1 or time from the date of randomization Phase II part 2 Cohort A to the date of death due to any cause. If a patient is not known to have died survival will be censored at the date of last contact.
Outcome measures
| Measure |
Phase II Part 2 - Cohort A - Anal Cancer - TG4001 5x10e7 Pfu + Avelumab
n=30 Participants
Participants without liver metastases received 5x10e7 pfu TG4001 subcutaneously along with 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
Phase II Part 2 - Cohort A - Anal Cancer - Avelumab
n=46 Participants
Participants without liver metastases received 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
Phase II Part 2 - Cohort A - Genital Cancer - TG4001 5x10e7 Pfu + Avelumab
n=44 Participants
Participants without liver metastases received 5x10e7 pfu TG4001 subcutaneously along with 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
Phase II Part 2 - Cohort A - Genital Cancer - Avelumab
Participants without liver metastases received 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
Phase I - TG4001 5x10e6 Pfu + Avelumab
n=3 Participants
Participants received 5x10e6 pfu TG4001 subcutaneously along with 10 mg/kg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
Phase I - TG4001 5x10e7 Pfu + Avelumab
n=6 Participants
Participants received 5x10e7 pfu TG4001 subcutaneously along with 10 mg/kg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
|---|---|---|---|---|---|---|
|
Overall Survival (OS) : Phase Ib, Phase II Part 1, Phase II Part 2 Cohort A
|
10.3 Months
Interval 6.2 to 13.3
|
16.6 Months
Interval 10.5 to 21.7
|
16.5 Months
Interval 10.0 to 19.6
|
—
|
5.6 Months
Interval 5.6 to
Upper limit of Confidence Interval has not been achieved due to insufficient number of participants with events.
|
26.2 Months
Interval 8.7 to
Upper limit of Confidence Interval has not been achieved due to insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: From treatment start Phase Ib, Phase II part 1 / from randomization Phase II part 2 Cohort A : every 6 weeks for the first 9 months, then every 12 weeks through study completion, for an average of 2.5 years.Population: For phase Ib, phase II part 1 and phase II part 2 Cohort A, analysis population consists of all included participants who were dosed with IMP(s) according to treatment allocation and who have a confirmed response according to RECIST1.1. For Phase II part 2 Cohort B, the outcome measure duration of overall response has not been defined as secondary endpoint. Therefore Phase II part 2 cohort B is not included in the analysis population.
Duration of overall response in weeks (DoR) applies only to patients whose best overall response is CR or PR. The start date is the date of first documented response (CR or PR) and the end date is the date of event defined as first documented disease progression or death due to underlying cancer.
Outcome measures
| Measure |
Phase II Part 2 - Cohort A - Anal Cancer - TG4001 5x10e7 Pfu + Avelumab
n=5 Participants
Participants without liver metastases received 5x10e7 pfu TG4001 subcutaneously along with 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
Phase II Part 2 - Cohort A - Anal Cancer - Avelumab
n=7 Participants
Participants without liver metastases received 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
Phase II Part 2 - Cohort A - Genital Cancer - TG4001 5x10e7 Pfu + Avelumab
n=6 Participants
Participants without liver metastases received 5x10e7 pfu TG4001 subcutaneously along with 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
Phase II Part 2 - Cohort A - Genital Cancer - Avelumab
Participants without liver metastases received 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
Phase I - TG4001 5x10e6 Pfu + Avelumab
Participants received 5x10e6 pfu TG4001 subcutaneously along with 10 mg/kg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
Phase I - TG4001 5x10e7 Pfu + Avelumab
n=3 Participants
Participants received 5x10e7 pfu TG4001 subcutaneously along with 10 mg/kg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
|---|---|---|---|---|---|---|
|
Duration of Overall Response (DoR): Phase Ib, Phase II Part 1, Phase II Part 2 Cohort A
|
25.1 Weeks
Interval 22.4 to 228.1
|
90.3 Weeks
Interval 12.1 to 138.4
|
55.9 Weeks
Interval 18.3 to 121.0
|
—
|
—
|
53.7 Weeks
Interval 40.7 to 239.7
|
SECONDARY outcome
Timeframe: From randomization: every 6 weeks up to 24 weeks.Population: Phase II part 2 Cohort B: All randomized participants administered with at least one dose of IMP(s) according to allocation at randomization (FAS). One participant (cohort B - Avelumab) was excluded from analysis because no IMP has been administered. Phase Ib, Phase II part 1 and Phase II part 2 Cohort A, proportion of progressive disease has not been defined as secondary endpoint. Therefore phase Ib, Phase II part 1 and Phase II part 2 Cohort A are not included in the analysis population.
Number of participants with liver metastases at baseline who has a documented disease progression as per RECIST1.1.
Outcome measures
| Measure |
Phase II Part 2 - Cohort A - Anal Cancer - TG4001 5x10e7 Pfu + Avelumab
Participants without liver metastases received 5x10e7 pfu TG4001 subcutaneously along with 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
Phase II Part 2 - Cohort A - Anal Cancer - Avelumab
Participants without liver metastases received 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
Phase II Part 2 - Cohort A - Genital Cancer - TG4001 5x10e7 Pfu + Avelumab
Participants without liver metastases received 5x10e7 pfu TG4001 subcutaneously along with 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
Phase II Part 2 - Cohort A - Genital Cancer - Avelumab
Participants without liver metastases received 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
Phase I - TG4001 5x10e6 Pfu + Avelumab
n=5 Participants
Participants received 5x10e6 pfu TG4001 subcutaneously along with 10 mg/kg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
Phase I - TG4001 5x10e7 Pfu + Avelumab
n=4 Participants
Participants received 5x10e7 pfu TG4001 subcutaneously along with 10 mg/kg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
|---|---|---|---|---|---|---|
|
Proportion of Progressive Disease Phase II Part 2 Cohort B
Progressive disease <= 12 weeks
|
—
|
—
|
—
|
—
|
3 Participants
|
3 Participants
|
|
Proportion of Progressive Disease Phase II Part 2 Cohort B
Progressive disease <= 24 weeks
|
—
|
—
|
—
|
—
|
3 Participants
|
3 Participants
|
|
Proportion of Progressive Disease Phase II Part 2 Cohort B
Non progressive disease
|
—
|
—
|
—
|
—
|
2 Participants
|
0 Participants
|
|
Proportion of Progressive Disease Phase II Part 2 Cohort B
Progressive disease <= 6 weeks
|
—
|
—
|
—
|
—
|
2 Participants
|
1 Participants
|
Adverse Events
Phase I - TG4001 5x10e6 Pfu + Avelumab
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Phase I - TG4001 5x10e7 Pfu + Avelumab
Serious events: 4 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase II Part 1 - TG4001 5x10e7 Pfu + Avelumab
Serious events: 18 serious events
Other events: 34 other events
Deaths: 12 deaths
Phase II Part 2 - Cohort A - Participants Without Liver Metastases - TG4001 5x10e7 Pfu + Avelumab
Serious events: 16 serious events
Other events: 46 other events
Deaths: 7 deaths
Phase II Part 2 - Cohort A - Participants Without Liver Metastases - Avelumab
Serious events: 18 serious events
Other events: 43 other events
Deaths: 5 deaths
Phase II Part 2 - Cohort B - Participants With Liver Metastases - TG4001 5x10e7 PFU + Avelumab
Serious events: 2 serious events
Other events: 5 other events
Deaths: 1 deaths
Phase II Part 2 - Cohort B - Participants With Liver Metastases - Avelumab
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase I - TG4001 5x10e6 Pfu + Avelumab
n=3 participants at risk
Participants received 5x10e6 pfu TG4001 subcutaneously along with 10 mg/kg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
Phase I - TG4001 5x10e7 Pfu + Avelumab
n=6 participants at risk
Participants received 5x10e7 pfu TG4001 subcutaneously along with 10 mg/kg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
Phase II Part 1 - TG4001 5x10e7 Pfu + Avelumab
n=34 participants at risk
Participants received 5x10e7 pfu TG4001 subcutaneously along with 10 mg/kg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
Phase II Part 2 - Cohort A - Participants Without Liver Metastases - TG4001 5x10e7 Pfu + Avelumab
n=46 participants at risk
Participants without liver metastasis received 5x10e7 pfu TG4001 subcutaneously along with 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
Phase II Part 2 - Cohort A - Participants Without Liver Metastases - Avelumab
n=44 participants at risk
Participants without liver metastasis received 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
Phase II Part 2 - Cohort B - Participants With Liver Metastases - TG4001 5x10e7 PFU + Avelumab
n=5 participants at risk
Participants with liver metastasis received 5x10e7 pfu TG4001 subcutaneously along with 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
Phase II Part 2 - Cohort B - Participants With Liver Metastases - Avelumab
n=4 participants at risk
Participants received 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Endocrine disorders
Hypercalcaemia of malignancy
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
20.0%
1/5 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Gastrointestinal disorders
Pneumoperitoneum
|
33.3%
1/3 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
General disorders
Disease progression
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
29.4%
10/34 • Number of events 10 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
General disorders
General physical health deterioration
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
5.9%
2/34 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
20.0%
1/5 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Immune system disorders
Anaphylactic shock
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Infections and infestations
Abdominal sepsis
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Infections and infestations
Clostridium colitis
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Infections and infestations
Device related infection
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Infections and infestations
Influenza
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Infections and infestations
Klebsiella infection
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Infections and infestations
Pneumonia aspiration
|
33.3%
1/3 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Infections and infestations
Septic shock
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
6.5%
3/46 • Number of events 3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Injury, poisoning and procedural complications
Febrile nonhaemolytic transfusion reaction
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Injury, poisoning and procedural complications
Scar
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
6.8%
3/44 • Number of events 3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Nervous system disorders
Central nervous system vasculitis
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
16.7%
1/6 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Nervous system disorders
Neurological symptom
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
16.7%
1/6 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
4.3%
2/46 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Renal and urinary disorders
Urinary bladder haemorrhage
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Reproductive system and breast disorders
Cervix haemorrhage uterine
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopneumopathy
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
16.7%
1/6 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
5.9%
2/34 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
16.7%
1/6 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
33.3%
1/3 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
20.0%
1/5 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Surgical and medical procedures
Nephrostomy
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
16.7%
1/6 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
Other adverse events
| Measure |
Phase I - TG4001 5x10e6 Pfu + Avelumab
n=3 participants at risk
Participants received 5x10e6 pfu TG4001 subcutaneously along with 10 mg/kg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
Phase I - TG4001 5x10e7 Pfu + Avelumab
n=6 participants at risk
Participants received 5x10e7 pfu TG4001 subcutaneously along with 10 mg/kg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
Phase II Part 1 - TG4001 5x10e7 Pfu + Avelumab
n=34 participants at risk
Participants received 5x10e7 pfu TG4001 subcutaneously along with 10 mg/kg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
Phase II Part 2 - Cohort A - Participants Without Liver Metastases - TG4001 5x10e7 Pfu + Avelumab
n=46 participants at risk
Participants without liver metastasis received 5x10e7 pfu TG4001 subcutaneously along with 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
Phase II Part 2 - Cohort A - Participants Without Liver Metastases - Avelumab
n=44 participants at risk
Participants without liver metastasis received 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
Phase II Part 2 - Cohort B - Participants With Liver Metastases - TG4001 5x10e7 PFU + Avelumab
n=5 participants at risk
Participants with liver metastasis received 5x10e7 pfu TG4001 subcutaneously along with 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
Phase II Part 2 - Cohort B - Participants With Liver Metastases - Avelumab
n=4 participants at risk
Participants received 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
66.7%
2/3 • Number of events 4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
44.1%
15/34 • Number of events 26 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
37.0%
17/46 • Number of events 43 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
29.5%
13/44 • Number of events 29 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
40.0%
2/5 • Number of events 4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Blood and lymphatic system disorders
Antiphospholipid syndrome
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Blood and lymphatic system disorders
Haematotoxicity
|
33.3%
1/3 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
25.0%
1/4 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
6.5%
3/46 • Number of events 3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
33.3%
1/3 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
5.9%
2/34 • Number of events 4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
10.9%
5/46 • Number of events 15 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
6.8%
3/44 • Number of events 7 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
25.0%
1/4 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
8.8%
3/34 • Number of events 4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
6.8%
3/44 • Number of events 4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
33.3%
1/3 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
4.3%
2/46 • Number of events 12 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
4.5%
2/44 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Cardiac disorders
Cardiac valve disease
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Cardiac disorders
Intracardiac thrombus
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
4.3%
2/46 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
16.7%
1/6 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Ear and labyrinth disorders
Middle ear inflammation
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
5.9%
2/34 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
4.5%
2/44 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
16.7%
1/6 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
4.3%
2/46 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
6.8%
3/44 • Number of events 3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
25.0%
1/4 • Number of events 4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Endocrine disorders
Goitre
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Endocrine disorders
Hypercalcaemia of malignancy
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
25.0%
1/4 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Endocrine disorders
Hyperparathyroidism
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Endocrine disorders
Hyperthyroidism
|
33.3%
1/3 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
11.8%
4/34 • Number of events 4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
17.4%
8/46 • Number of events 8 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
11.4%
5/44 • Number of events 5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
25.0%
1/4 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
16.7%
1/6 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
8.8%
3/34 • Number of events 4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
15.2%
7/46 • Number of events 7 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
6.8%
3/44 • Number of events 4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Endocrine disorders
Thyroiditis
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Eye disorders
Blepharitis
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Eye disorders
Dry eye
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Eye disorders
Eczema eyelids
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Eye disorders
Eye pruritus
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Eye disorders
Eyelid ptosis
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Eye disorders
Ocular discomfort
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Eye disorders
Visual impairment
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Eye disorders
Vitreous detachment
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
16.7%
1/6 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Eye disorders
Xerophthalmia
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
16.7%
1/6 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
11.8%
4/34 • Number of events 4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
19.6%
9/46 • Number of events 10 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
18.2%
8/44 • Number of events 13 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
20.0%
1/5 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
50.0%
2/4 • Number of events 3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
4.5%
2/44 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
20.0%
1/5 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
25.0%
1/4 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Gastrointestinal disorders
Anal incontinence
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
16.7%
1/6 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Gastrointestinal disorders
Angular cheilitis
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
16.7%
1/6 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Gastrointestinal disorders
Anorectal discomfort
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
16.7%
1/6 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
38.2%
13/34 • Number of events 14 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
19.6%
9/46 • Number of events 12 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
22.7%
10/44 • Number of events 18 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
20.0%
1/5 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
25.0%
1/4 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Gastrointestinal disorders
Defaecation urgency
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Gastrointestinal disorders
Dental cyst
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
16.7%
1/6 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
1/3 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
50.0%
3/6 • Number of events 6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
14.7%
5/34 • Number of events 12 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
37.0%
17/46 • Number of events 23 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
29.5%
13/44 • Number of events 28 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
80.0%
4/5 • Number of events 6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
50.0%
2/4 • Number of events 11 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
16.7%
1/6 • Number of events 4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
5.9%
2/34 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Gastrointestinal disorders
Dysphagia
|
33.3%
1/3 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
33.3%
2/6 • Number of events 7 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Gastrointestinal disorders
Gastrointestinal motility disorder
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
4.5%
2/44 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
4.3%
2/46 • Number of events 4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
20.0%
1/5 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Gastrointestinal disorders
Glossitis
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
5.9%
2/34 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
4.3%
2/46 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Gastrointestinal disorders
Immune-mediated enterocolitis
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
25.0%
1/4 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
16.7%
1/6 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Gastrointestinal disorders
Malignant ascites
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Gastrointestinal disorders
Malignant dysphagia
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
16.7%
1/6 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
16.7%
1/6 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Gastrointestinal disorders
Mucous stools
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
17.6%
6/34 • Number of events 9 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
17.4%
8/46 • Number of events 9 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
13.6%
6/44 • Number of events 10 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
20.0%
1/5 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
50.0%
2/4 • Number of events 6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
16.7%
1/6 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
4.3%
2/46 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Gastrointestinal disorders
Proctitis
|
33.3%
1/3 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
4.5%
2/44 • Number of events 3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
20.0%
1/5 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Gastrointestinal disorders
Rectal tenesmus
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
16.7%
1/6 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
4.5%
2/44 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
4.3%
2/46 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Gastrointestinal disorders
Tongue coated
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
16.7%
1/6 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
20.0%
1/5 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Gastrointestinal disorders
Trichoglossia
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
14.7%
5/34 • Number of events 7 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
19.6%
9/46 • Number of events 14 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
13.6%
6/44 • Number of events 8 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
20.0%
1/5 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
General disorders
Asthenia
|
66.7%
2/3 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
50.0%
3/6 • Number of events 4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
26.5%
9/34 • Number of events 14 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
34.8%
16/46 • Number of events 29 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
31.8%
14/44 • Number of events 27 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
20.0%
1/5 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
50.0%
2/4 • Number of events 5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
General disorders
Chest pain
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
General disorders
Chills
|
33.3%
1/3 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
16.7%
1/6 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
11.8%
4/34 • Number of events 4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
21.7%
10/46 • Number of events 11 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
11.4%
5/44 • Number of events 8 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
General disorders
Face oedema
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
General disorders
Fatigue
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
50.0%
3/6 • Number of events 3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
23.5%
8/34 • Number of events 11 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
19.6%
9/46 • Number of events 17 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
22.7%
10/44 • Number of events 22 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
40.0%
2/5 • Number of events 5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
50.0%
2/4 • Number of events 5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
General disorders
Feeling cold
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
General disorders
Gait disturbance
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
General disorders
General physical health deterioration
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
4.5%
2/44 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
General disorders
Hyperthermia
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
6.5%
3/46 • Number of events 3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
4.5%
2/44 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
General disorders
Influenza like illness
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
5.9%
2/34 • Number of events 4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
General disorders
Injection site discomfort
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
General disorders
Injection site erythema
|
33.3%
1/3 • Number of events 3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
66.7%
4/6 • Number of events 6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
23.5%
8/34 • Number of events 16 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
26.1%
12/46 • Number of events 29 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
20.0%
1/5 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
General disorders
Injection site haematoma
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
8.8%
3/34 • Number of events 3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
General disorders
Injection site induration
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
15.2%
7/46 • Number of events 15 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
General disorders
Injection site inflammation
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
14.7%
5/34 • Number of events 11 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
13.0%
6/46 • Number of events 7 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
General disorders
Injection site nodule
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
6.5%
3/46 • Number of events 4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
General disorders
Injection site oedema
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
33.3%
2/6 • Number of events 4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
14.7%
5/34 • Number of events 15 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
4.3%
2/46 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
General disorders
Injection site pain
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
16.7%
1/6 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
17.6%
6/34 • Number of events 7 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
17.4%
8/46 • Number of events 15 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
20.0%
1/5 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
General disorders
Injection site pruritus
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
4.3%
2/46 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
General disorders
Injection site rash
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
11.8%
4/34 • Number of events 5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
4.3%
2/46 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
General disorders
Injection site reaction
|
33.3%
1/3 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
20.6%
7/34 • Number of events 8 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
17.4%
8/46 • Number of events 12 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
40.0%
2/5 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
General disorders
Injection site swelling
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
General disorders
Localised oedema
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
General disorders
Malaise
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
4.3%
2/46 • Number of events 3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
General disorders
Medical device site joint pain
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
16.7%
1/6 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
General disorders
Oedema
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
25.0%
1/4 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
16.7%
1/6 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
17.6%
6/34 • Number of events 7 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
15.2%
7/46 • Number of events 11 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
11.4%
5/44 • Number of events 11 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
20.0%
1/5 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
25.0%
1/4 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
General disorders
Pain
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
5.9%
2/34 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
General disorders
Peripheral swelling
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
General disorders
Pyrexia
|
66.7%
2/3 • Number of events 6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
50.0%
3/6 • Number of events 6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
41.2%
14/34 • Number of events 25 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
39.1%
18/46 • Number of events 37 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
18.2%
8/44 • Number of events 13 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
40.0%
2/5 • Number of events 3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
General disorders
Swelling
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
16.7%
1/6 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
General disorders
Ulcer
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
General disorders
Vaccination site erythema
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
General disorders
Vascular device occlusion
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
General disorders
Xerosis
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
16.7%
1/6 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Hepatobiliary disorders
Hepatic cytolysis
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
8.8%
3/34 • Number of events 3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
6.5%
3/46 • Number of events 5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Hepatobiliary disorders
Hepatic pain
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Immune system disorders
Contrast media allergy
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
4.3%
2/46 • Number of events 3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
16.7%
1/6 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
4.3%
2/46 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
4.5%
2/44 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Infections and infestations
COVID-19
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
16.7%
1/6 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
8.7%
4/46 • Number of events 6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
4.5%
2/44 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
20.0%
1/5 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Infections and infestations
Candida infection
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Infections and infestations
Cystitis
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
5.9%
2/34 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Infections and infestations
Cystitis escherichia
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
20.0%
1/5 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Infections and infestations
Enterococcal infection
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
16.7%
1/6 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Infections and infestations
Furuncle
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
16.7%
1/6 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
16.7%
1/6 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
4.5%
2/44 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
20.0%
1/5 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
25.0%
1/4 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
16.7%
1/6 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
4.5%
2/44 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Infections and infestations
Herpes virus infection
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Infections and infestations
Implant site infection
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Infections and infestations
Infection
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Infections and infestations
Influenza
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
5.9%
2/34 • Number of events 6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
4.5%
2/44 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Infections and infestations
Laryngitis
|
33.3%
1/3 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
25.0%
1/4 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
6.5%
3/46 • Number of events 3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
4.5%
2/44 • Number of events 4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
20.0%
1/5 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
25.0%
1/4 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Infections and infestations
Oral fungal infection
|
33.3%
1/3 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
16.7%
1/6 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
16.7%
1/6 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Infections and infestations
Oral infection
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
16.7%
1/6 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
25.0%
1/4 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
6.8%
3/44 • Number of events 3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
4.5%
2/44 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
5.9%
2/34 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
20.0%
1/5 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Infections and infestations
Root canal infection
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
16.7%
1/6 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
16.7%
1/6 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
20.0%
1/5 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
20.0%
1/5 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
29.4%
10/34 • Number of events 15 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
4.3%
2/46 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
6.8%
3/44 • Number of events 3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
40.0%
2/5 • Number of events 3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Infections and infestations
Vaginal abscess
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Injury, poisoning and procedural complications
Animal scratch
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Injury, poisoning and procedural complications
Eschar
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
8.7%
4/46 • Number of events 5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
4.5%
2/44 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
20.0%
1/5 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
16.7%
1/6 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
20.0%
1/5 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Injury, poisoning and procedural complications
Radiation injury
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
14.7%
5/34 • Number of events 6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
4.5%
2/44 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Investigations
Amylase increased
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
4.5%
2/44 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
1/3 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
11.8%
4/34 • Number of events 6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
4.3%
2/46 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
6.8%
3/44 • Number of events 4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Investigations
Blood albumin decreased
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Investigations
Blood alkaline phosphatase
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Investigations
Blood creatine increased
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
14.7%
5/34 • Number of events 6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
10.9%
5/46 • Number of events 7 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
4.5%
2/44 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
20.0%
1/5 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Investigations
Blood folate decreased
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
16.7%
1/6 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Investigations
Blood glucose increased
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
25.0%
1/4 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Investigations
Blood pressure increased
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
16.7%
1/6 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
5.9%
2/34 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
25.0%
1/4 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Investigations
Brain natriuretic peptide increased
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
5.9%
2/34 • Number of events 3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
4.5%
2/44 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Investigations
Creatinine renal clearance decreased
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
16.7%
1/6 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Investigations
Faecal volume increased
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
16.7%
1/6 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
4.3%
2/46 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Investigations
Glomerular filtration rate decreased
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
16.7%
1/6 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Investigations
Intestinal transit time increased
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Investigations
Lipase decreased
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Investigations
Lipase increased
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
8.7%
4/46 • Number of events 6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
6.8%
3/44 • Number of events 4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Investigations
Monocyte count increased
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Investigations
Neutrophil count increased
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Investigations
Thyroxine free decreased
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Investigations
Transaminases increased
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
5.9%
2/34 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Investigations
Troponin increased
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Investigations
Weight decreased
|
33.3%
1/3 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Investigations
Weight increased
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
25.0%
1/4 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Metabolism and nutrition disorders
Abnormal loss of weight
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
4.3%
2/46 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
9.1%
4/44 • Number of events 4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
20.0%
1/5 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Metabolism and nutrition disorders
Abnormal weight gain
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
1/3 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
33.3%
2/6 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
32.4%
11/34 • Number of events 12 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
23.9%
11/46 • Number of events 11 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
6.8%
3/44 • Number of events 4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
25.0%
1/4 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Metabolism and nutrition disorders
Folate deficiency
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
16.7%
1/6 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
17.6%
6/34 • Number of events 8 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
4.3%
2/46 • Number of events 3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
9.1%
4/44 • Number of events 6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
25.0%
1/4 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
5.9%
2/34 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
5.9%
2/34 • Number of events 3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
13.0%
6/46 • Number of events 7 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
4.5%
2/44 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
8.8%
3/34 • Number of events 3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
4.3%
2/46 • Number of events 5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
9.1%
4/44 • Number of events 4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
20.0%
1/5 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
6.5%
3/46 • Number of events 3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
4.5%
2/44 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
6.5%
3/46 • Number of events 3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
5.9%
2/34 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
4.5%
2/44 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Metabolism and nutrition disorders
Hypozincaemia
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
4.3%
2/46 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
11.4%
5/44 • Number of events 5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
25.0%
1/4 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Metabolism and nutrition disorders
Pseudohyponatraemia
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
25.0%
1/4 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
33.3%
2/6 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
14.7%
5/34 • Number of events 9 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
23.9%
11/46 • Number of events 19 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
20.5%
9/44 • Number of events 16 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
40.0%
2/5 • Number of events 3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
50.0%
2/4 • Number of events 4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
16.7%
1/6 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
11.8%
4/34 • Number of events 4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
17.4%
8/46 • Number of events 10 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
18.2%
8/44 • Number of events 13 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
16.7%
1/6 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
25.0%
1/4 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Musculoskeletal and connective tissue disorders
Coccydynia
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
20.0%
1/5 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle contracture
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle discomfort
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle fatigue
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
25.0%
1/4 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
33.3%
2/6 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
8.8%
3/34 • Number of events 3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
4.3%
2/46 • Number of events 3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
6.8%
3/44 • Number of events 3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
25.0%
1/4 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle swelling
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
16.7%
1/6 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
16.7%
1/6 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
4.3%
2/46 • Number of events 3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
33.3%
1/3 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
5.9%
2/34 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
6.5%
3/46 • Number of events 11 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
6.8%
3/44 • Number of events 3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
25.0%
1/4 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
33.3%
2/6 • Number of events 3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
4.3%
2/46 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
25.0%
1/4 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
10.9%
5/46 • Number of events 5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
9.1%
4/44 • Number of events 5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
20.0%
1/5 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
16.7%
1/6 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Musculoskeletal and connective tissue disorders
Sacral pain
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Musculoskeletal and connective tissue disorders
Sjogren's syndrome
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
16.7%
1/6 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
25.0%
1/4 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
11.8%
4/34 • Number of events 4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oncologic complication
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
33.3%
1/3 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
8.8%
3/34 • Number of events 4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
20.0%
1/5 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour inflammation
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
33.3%
1/3 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
16.7%
1/6 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
29.4%
10/34 • Number of events 15 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
19.6%
9/46 • Number of events 12 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
18.2%
8/44 • Number of events 13 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
20.0%
1/5 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
25.0%
1/4 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour ulceration
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
16.7%
1/6 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Nervous system disorders
Cervicogenic headache
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Nervous system disorders
Clonus
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
16.7%
1/6 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
4.3%
2/46 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
4.5%
2/44 • Number of events 3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
33.3%
2/6 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
17.4%
8/46 • Number of events 18 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
13.6%
6/44 • Number of events 12 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
20.0%
1/5 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
25.0%
1/4 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
16.7%
1/6 • Number of events 4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Nervous system disorders
Hypokinesia
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Nervous system disorders
Migraine
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
20.0%
1/5 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Nervous system disorders
Motor dysfunction
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Nervous system disorders
Muscle contractions involuntary
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
33.3%
2/6 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
6.8%
3/44 • Number of events 3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
16.7%
1/6 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
4.3%
2/46 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
4.5%
2/44 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
16.7%
1/6 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
5.9%
2/34 • Number of events 4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
25.0%
1/4 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Nervous system disorders
Radicular pain
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
16.7%
1/6 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Nervous system disorders
Resting tremor
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
33.3%
2/6 • Number of events 4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
4.3%
2/46 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
4.5%
2/44 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Nervous system disorders
Tremor
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
4.3%
2/46 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Product Issues
Device occlusion
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Psychiatric disorders
Affect lability
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
16.7%
1/6 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
11.8%
4/34 • Number of events 4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
6.8%
3/44 • Number of events 7 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
4.3%
2/46 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Psychiatric disorders
Enuresis
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
8.7%
4/46 • Number of events 4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
6.8%
3/44 • Number of events 6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
20.0%
1/5 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Renal and urinary disorders
Bladder discomfort
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
16.7%
1/6 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
8.8%
3/34 • Number of events 3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
8.7%
4/46 • Number of events 4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
9.1%
4/44 • Number of events 4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
13.0%
6/46 • Number of events 9 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
6.8%
3/44 • Number of events 3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Renal and urinary disorders
Nephropathy
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Renal and urinary disorders
Nephropathy toxic
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
20.0%
1/5 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
4.5%
2/44 • Number of events 3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
16.7%
1/6 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Renal and urinary disorders
Pyelocaliectasis
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
5.9%
2/34 • Number of events 4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
10.9%
5/46 • Number of events 6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Renal and urinary disorders
Ureteral spasm
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
8.7%
4/46 • Number of events 4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
6.8%
3/44 • Number of events 4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Renal and urinary disorders
Urine abnormality
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Renal and urinary disorders
Urogenital fistula
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Reproductive system and breast disorders
Epididymal cyst
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
16.7%
1/6 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Reproductive system and breast disorders
Female genital tract fistula
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Reproductive system and breast disorders
Heavy menstrual bleeding
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Reproductive system and breast disorders
Intermenstrual bleeding
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
16.7%
1/6 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
4.5%
2/44 • Number of events 3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Reproductive system and breast disorders
Menometrorrhagia
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Reproductive system and breast disorders
Pelvic discomfort
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
6.8%
3/44 • Number of events 4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Reproductive system and breast disorders
Perineal pain
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Reproductive system and breast disorders
Testicular oedema
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Reproductive system and breast disorders
Uterine cervical pain
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
5.9%
2/34 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
20.0%
1/5 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Reproductive system and breast disorders
Vaginal odour
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Reproductive system and breast disorders
Vulval disorder
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Reproductive system and breast disorders
Vulval oedema
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
20.0%
1/5 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Reproductive system and breast disorders
Vulvovaginal discomfort
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Reproductive system and breast disorders
Vulvovaginal pain
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
20.0%
1/5 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
4.3%
2/46 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
4.5%
2/44 • Number of events 3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
50.0%
3/6 • Number of events 4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
5.9%
2/34 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
19.6%
9/46 • Number of events 10 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
13.6%
6/44 • Number of events 7 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
20.0%
1/5 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
25.0%
1/4 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
33.3%
2/6 • Number of events 4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
20.6%
7/34 • Number of events 7 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
8.7%
4/46 • Number of events 7 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
6.8%
3/44 • Number of events 3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
20.0%
1/5 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
25.0%
1/4 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
16.7%
1/6 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
16.7%
1/6 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
20.0%
1/5 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
16.7%
1/6 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal haemorrhage
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
33.3%
2/6 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal obstruction
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
5.9%
2/34 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngeal reflux
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
25.0%
1/4 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
5.9%
2/34 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
6.5%
3/46 • Number of events 3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary artery occlusion
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
16.7%
1/6 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
10.9%
5/46 • Number of events 5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
16.7%
1/6 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Respiratory, thoracic and mediastinal disorders
Throat tightness
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal fistula
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
16.7%
1/6 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
10.9%
5/46 • Number of events 5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
6.8%
3/44 • Number of events 3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
4.5%
2/44 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Skin and subcutaneous tissue disorders
Hand dermatitis
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
4.5%
2/44 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Skin and subcutaneous tissue disorders
Lichenoid keratosis
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
16.7%
1/6 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Skin and subcutaneous tissue disorders
Nail dystrophy
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
16.7%
1/6 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
8.8%
3/34 • Number of events 5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
8.7%
4/46 • Number of events 4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
13.6%
6/44 • Number of events 10 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Skin and subcutaneous tissue disorders
Rash
|
33.3%
1/3 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
16.7%
1/6 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
4.3%
2/46 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
6.8%
3/44 • Number of events 3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
16.7%
1/6 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
16.7%
1/6 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
33.3%
1/3 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Skin and subcutaneous tissue disorders
Rash vesicular
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
16.7%
1/6 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
4.3%
2/46 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
6.8%
3/44 • Number of events 6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Skin and subcutaneous tissue disorders
Skin lesion inflammation
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Skin and subcutaneous tissue disorders
Transient acantholytic dermatosis
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
4.5%
2/44 • Number of events 3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Skin and subcutaneous tissue disorders
Vascular purpura
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
16.7%
1/6 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
20.0%
1/5 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Skin and subcutaneous tissue disorders
Xeroderma
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Vascular disorders
Haematoma
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Vascular disorders
Hot flush
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
6.8%
3/44 • Number of events 3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
20.0%
1/5 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
16.7%
1/6 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
8.8%
3/34 • Number of events 3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
4.5%
2/44 • Number of events 2 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Vascular disorders
Lymphostasis
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Vascular disorders
Vena cava thrombosis
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.2%
1/46 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/44 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/3 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/6 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/34 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/46 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
2.3%
1/44 • Number of events 1 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/5 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
0.00%
0/4 • All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place